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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02003924
Registration number
NCT02003924
Ethics application status
Date submitted
3/12/2013
Date registered
6/12/2013
Date last updated
23/04/2024
Titles & IDs
Public title
Safety and Efficacy Study of Enzalutamide in Patients With Nonmetastatic Castration-Resistant Prostate Cancer
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Scientific title
PROSPER: A MULTINATIONAL, PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, EFFICACY AND SAFETY STUDY OF ENZALUTAMIDE IN PATIENTS WITH NONMETASTATIC CASTRATION-RESISTANT PROSTATE CANCER
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Secondary ID [1]
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C3431005
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Secondary ID [2]
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MDV3100-14
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Universal Trial Number (UTN)
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Trial acronym
PROSPER
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Nonmetastatic Castration-Resistant Prostate Cancer
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Prostate Cancer
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Cancer of the Prostate
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Condition category
Condition code
Cancer
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Prostate
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Enzalutamide
Treatment: Drugs - Placebo
Sham Comparator: Placebo - Sugar pill manufactured to mimic enzalutamide 40 mg capsule
Experimental: Enzalutamide - 160 mg by mouth once daily
Treatment: Drugs: Enzalutamide
160 mg by mouth once daily
Treatment: Drugs: Placebo
Sugar pill to mimic enzalutamide
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Metastasis Free Survival (MFS)
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Assessment method [1]
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MFS:time from randomization to first date of radiographic progression (RP) (by Blinded independent central radiology review [BICR]) at any time or death within 112 days of treatment discontinuation without evidence of RP.RP for bone disease:appearance of 1 or more metastatic lesions on bone scan.RP for soft tissue disease:per Response Evaluation Criteria in Solid Tumors,[RECIST 1.1])-at least a 20 percent (%) increase in the sum of diameters of target lesions,taking as reference the smallest sum on study (includes the baseline sum if smallest on study).Participants who did not have MFS event at the time of analysis data cut-off (28 June 2017) were censored at date of last assessment showing no objective evidence of RP prior to skeletal-related event or two or more consecutive missed tumor assessments. Participants who were randomized but later confirmed to have metastatic disease before randomization were censored on date of randomization. Analysis was based on Kaplan-Meier estimates.
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Timepoint [1]
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From randomization until radiographic progression at any time, or death within 112 days of treatment discontinuation, whichever occurred first (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months)
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Secondary outcome [1]
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Time to Prostate-Specific Antigen (PSA) Progression
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Assessment method [1]
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Time to PSA progression was defined as the time from randomization to the date of first PSA value demonstrating progression, which was subsequently confirmed. For participants with PSA decline at Week 17, PSA progression was defined according to Prostate Cancer Working Group 2 (PCWG2) guidelines as the date that a 25% or greater increase and an absolute increase of 2 nanograms per milliliter (ng/mL) above the nadir (or baseline for participants with no PSA decline by Week 17) was documented, which was confirmed by a second consecutive value obtained at least 3 weeks or later. Participants without confirmed PSA progression at the time of analysis were right censored at the date of last PSA assessment before the analysis data cut-off date for the purposes of analysis. Analysis was based on Kaplan-Meier estimates.
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Timepoint [1]
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From randomization until first PSA progression (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months)
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Secondary outcome [2]
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Time to First Use of New Antineoplastic Therapy
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Assessment method [2]
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Time to first use of new antineoplastic therapy was defined as the time from randomization to first use of new antineoplastic for prostate cancer. Participants not starting treatment with a new antineoplastic therapy at the time of analysis were right censored at the date of last assessment before the analysis data cutoff date for the purposes of analysis. Analysis was based on Kaplan-Meier estimates.
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Timepoint [2]
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From randomization until first use of new antineoplastic therapy(until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months)
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Secondary outcome [3]
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Overall Survival
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Assessment method [3]
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Overall survival (OS) was defined as the time (in months) from randomization to death from any cause. For participants who were alive at the time of the analysis data cutoff, OS time was censored at the last date the participant was known to be alive or analysis data cutoff date, whichever was earlier. Participants with no post baseline survival information were censored on the date of randomization. Analysis was based on Kaplan-Meier estimates.
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Timepoint [3]
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From randomization until death (up to a maximum of 68.8 months)
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Secondary outcome [4]
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Time to Pain Progression
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Assessment method [4]
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Pain was assessed using the score from the Brief Pain Inventory-Short Form (BPI-SF) question 3: "Please rate your pain by marking the box beside the number that best describes your pain at its worst in the last 24 hours." Time to this event was defined as the time from randomization to onset of pain progression, where pain progression was defined as a 2-point or more increase from baseline in the question 3 score. Participants without observed pain progression at the time of analysis were right censored at the date of last pain assessment for the purposes of analysis. Analysis was based on Kaplan-Meier estimates.
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Timepoint [4]
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From randomization until onset of pain progression (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months)
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Secondary outcome [5]
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Time to First Use of Cytotoxic Chemotherapy
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Assessment method [5]
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Time to first use of cytotoxic chemotherapy was defined as the time from randomization to the first use of cytotoxic chemotherapy for prostate cancer. Participants not starting treatment with a cytotoxic chemotherapy for prostate cancer at the time of analysis were right censored at the date of last assessment before the analysis data cutoff date for the purposes of analysis. Analysis was based on Kaplan-Meier estimates.
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Timepoint [5]
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From randomization up to the first use of cytotoxic chemotherapy (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months)
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Secondary outcome [6]
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Chemotherapy-Free Disease Specific Survival
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Assessment method [6]
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Chemotherapy-free disease-specific survival was defined as the time from randomization to first use of cytotoxic chemotherapy for prostate cancer or death due to prostate cancer as assessed by the investigator. Participants not starting treatment with a cytotoxic chemotherapy or not known to have died due to prostate cancer at the time of analysis were right censored at the date of last assessment before the analysis data cutoff date for the purposes of analysis. Analysis was based on Kaplan-Meier estimates.
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Timepoint [6]
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From randomization up to first use of cytotoxic chemotherapy for prostate cancer or death due to prostate cancer (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months)
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Secondary outcome [7]
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Chemotherapy-Free Survival
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Assessment method [7]
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Chemotherapy-free survival was defined as the time from randomization to first use of cytotoxic chemotherapy for prostate cancer or death due to any cause. Participants not starting treatment with a cytotoxic chemotherapy or not known to have died at the time of analysis were censored at the date of last assessment before the analysis data cutoff date for the purposes of analysis. Analysis was based on Kaplan-Meier estimates.
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Timepoint [7]
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From randomization up to first use of cytotoxic chemotherapy for prostate cancer or death due to any cause (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months)
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Secondary outcome [8]
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Percentage of Participants With Prostate Specific Antigen (PSA) Response
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Assessment method [8]
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PSA response was calculated at each visit as a decline from baseline in PSA (ng/mL) to the maximal PSA response with thresholds at 50% and 90%. Additionally, PSA response was assessed as a decline to undetectable levels, where undetectable level was defined as below the limit of quantification of the centrally assessed PSA results (the lower limit of quantification was 0.02 ng/mL). PSA response was confirmed by a second consecutive value at least 3 weeks later.
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Timepoint [8]
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From randomization until first PSA progression (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months)
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Secondary outcome [9]
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Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Global Score
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Assessment method [9]
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The FACT-P questionnaire is a multidimensional, self-reported quality of life instrument consisting of 27 core items that assess participant function in 4 domains: physical, social/family, emotional, functional well-being, and supplemented by 12 site-specific items to assess prostate-related symptoms. Each item was rated on a 0 to 4 Likert-type scale, and then combined to produce subscale scores for each domain, as well as a global quality of life score which ranged from 0 to 156 where higher scores represented better quality of life.
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Timepoint [9]
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Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177
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Secondary outcome [10]
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Number of Participants With European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Mobility Domain Score
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Assessment method [10]
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EQ-5D-5L is a standardized instrument that measures health-related quality of life for men with prostate cancer. EQ-5D consists of EQ-5D descriptive system and EQ visual analogue scale (VAS). EQ-5D descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems. Number of participants with various responses to the mobility questionnaire are reported.
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Timepoint [10]
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Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177
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Secondary outcome [11]
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Number of Participants With European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Self-Care Domain Score
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Assessment method [11]
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EQ-5D-5L is a standardized instrument that measures health-related quality of life for men with prostate cancer. EQ-5D consists of EQ-5D descriptive system and EQ VAS. EQ-5D descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems. Number of participants with various responses to the self-care questionnaire are reported.
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Timepoint [11]
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Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177
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Secondary outcome [12]
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Number of Participants With European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Usual Activities Domain Score
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Assessment method [12]
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EQ-5D-5L is a standardized instrument that measures health-related quality of life for men with prostate cancer. EQ-5D consists of EQ-5D descriptive system and EQ visual analogue scale (VAS). EQ-5D descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems. Number of participants with various responses to the usual activities questionnaire are reported.
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Timepoint [12]
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Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177
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Secondary outcome [13]
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Number of Participants With European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Pain/Discomfort Domain Score
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Assessment method [13]
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EQ-5D-5L is a standardized instrument that measures health-related quality of life for men with prostate cancer. EQ-5D consists of EQ-5D descriptive system and EQ visual analogue scale (VAS). EQ-5D descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems. Number of participants with various responses to the pain/discomfort questionnaire are reported.
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Timepoint [13]
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Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177
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Secondary outcome [14]
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Number of Participants With European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Anxiety/ Depression Domain Score
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Assessment method [14]
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EQ-5D-5L is a standardized instrument that measures health-related quality of life for men with prostate cancer. EQ-5D consists of EQ-5D descriptive system and EQ visual analogue scale (VAS). EQ-5D descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems. Number of participants with various responses to the anxiety/depression questionnaire are reported.
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Timepoint [14]
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Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177
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Secondary outcome [15]
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European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Overall Health Status Visual Analog Score (VAS)
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Assessment method [15]
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EQ-5D-5L is a standardized instrument that measures health-related quality of life for men with prostate cancer. EQ-5D consists of EQ-5D descriptive system and EQ VAS. EQ-5D-5L-VAS records participant's self-rated health on a vertical VAS that allows them to indicate their health state that can range from 0 (worst imaginable) to 100 (best imaginable), higher scores indicating a better health state.
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Timepoint [15]
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Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177
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Secondary outcome [16]
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Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 31
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Assessment method [16]
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The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 31 are reported. Question 31 was following: "Have you had to urinate frequently during the day?"
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Timepoint [16]
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Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177
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Secondary outcome [17]
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Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 32
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Assessment method [17]
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The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 32 are reported. Question 32 was following: "Have you had to urinate frequently at night?"
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Timepoint [17]
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Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177
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Secondary outcome [18]
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Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 33
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Assessment method [18]
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The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 33 are reported. Question 33 was following: "When you felt the urge to pass urine, did you have to hurry to get to the toilet?"
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Timepoint [18]
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Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177
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Secondary outcome [19]
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Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 34
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Assessment method [19]
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The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 34 are reported. Question 34 was following: "Was it difficult for you to get enough sleep, because you needed to get up frequently at night to urinate?"
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Timepoint [19]
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Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177
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Secondary outcome [20]
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Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 35
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Assessment method [20]
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The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 35 are reported. Question 35 was following: "Have you had difficulty going out of the house because you needed to be close to a toilet?"
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Timepoint [20]
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Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177
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Secondary outcome [21]
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Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 36
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Assessment method [21]
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The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 36 are reported. Question 36 was following: "Have you had any unintentional release (leakage) of urine?"
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Timepoint [21]
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Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177
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Secondary outcome [22]
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Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 37
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Assessment method [22]
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The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 37 are reported. Question 37 was following: "Did you have pain when you urinated?"
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Timepoint [22]
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Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177
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Secondary outcome [23]
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Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 38
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Assessment method [23]
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0
The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 38 are reported. Question 38 was following: "Has wearing an incontinence aid been a problem for you?". This question was answered by only those participants who wore incontinence aid.
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Timepoint [23]
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Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177
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Secondary outcome [24]
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Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 39
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Assessment method [24]
0
0
The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 39 are reported. Question 39 was following: "Have your daily activities been limited by your urinary problems?"
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Timepoint [24]
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Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177
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Secondary outcome [25]
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Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 40
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Assessment method [25]
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0
The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 40 are reported. Question 40 was following: "Have your daily activities been limited by your bowel problems?"
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Timepoint [25]
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0
Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177
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Secondary outcome [26]
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0
Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 41
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Assessment method [26]
0
0
The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 41 are reported. Question 41 was following: "Have you had any unintentional release (leakage) of stools?"
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Timepoint [26]
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0
Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177
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Secondary outcome [27]
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0
Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 42
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Assessment method [27]
0
0
The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 42 are reported. Question 42 was following: "Have you had blood in your stools?"
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Timepoint [27]
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0
Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177
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Secondary outcome [28]
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0
Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 43
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Assessment method [28]
0
0
The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 43 are reported. Question 43 was following: "Did you have a bloated feeling in your abdomen?"
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Timepoint [28]
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0
Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177
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Secondary outcome [29]
0
0
Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 44
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Assessment method [29]
0
0
The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 44 are reported. Question 44 was following: "Did you have hot flushes?"
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Timepoint [29]
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0
Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177
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Secondary outcome [30]
0
0
Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 45
Query!
Assessment method [30]
0
0
The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 45 are reported. Question 45 was following: "Have you had sore or enlarged nipples or breasts?"
Query!
Timepoint [30]
0
0
Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177
Query!
Secondary outcome [31]
0
0
Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 46
Query!
Assessment method [31]
0
0
The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 46 are reported. Question 46 was following: "Have you had swelling in your legs or ankles?"
Query!
Timepoint [31]
0
0
Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177
Query!
Secondary outcome [32]
0
0
Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 47
Query!
Assessment method [32]
0
0
The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 47 are reported. Question 47 was following: "Has weight loss been a problem for you?"
Query!
Timepoint [32]
0
0
Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177
Query!
Secondary outcome [33]
0
0
Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 48
Query!
Assessment method [33]
0
0
The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 48 are reported. Question 48 was following: "Has weight gain been a problem for you?"
Query!
Timepoint [33]
0
0
Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177
Query!
Secondary outcome [34]
0
0
Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 49
Query!
Assessment method [34]
0
0
The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 49 are reported. Question 49 was following: "Have you felt less masculine as a result of your illness or treatment?"
Query!
Timepoint [34]
0
0
Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177
Query!
Secondary outcome [35]
0
0
Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 50
Query!
Assessment method [35]
0
0
The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 50 are reported. Question 50 was following: "To what extent were you interested in sex?"
Query!
Timepoint [35]
0
0
Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177
Query!
Secondary outcome [36]
0
0
Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 51
Query!
Assessment method [36]
0
0
The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 51 are reported. Question 51 was following: "To what extent were you sexually active (with or without intercourse)?"
Query!
Timepoint [36]
0
0
Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177
Query!
Secondary outcome [37]
0
0
Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 52
Query!
Assessment method [37]
0
0
The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 52 are reported. Question 52 was following: "To what extent was sex enjoyable for you?"
Query!
Timepoint [37]
0
0
Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177
Query!
Secondary outcome [38]
0
0
Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 53
Query!
Assessment method [38]
0
0
The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 53 are reported. Question 53 was following: "Did you have difficulty getting or maintaining an erection?"
Query!
Timepoint [38]
0
0
Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177
Query!
Secondary outcome [39]
0
0
Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 54
Query!
Assessment method [39]
0
0
The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 54 are reported. Question 54 was following: "Did you have ejaculation problems (e.g, dry ejaculation)?"
Query!
Timepoint [39]
0
0
Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177
Query!
Secondary outcome [40]
0
0
Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 55
Query!
Assessment method [40]
0
0
The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 55 are reported. Question 55 was following: "Have you felt uncomfortable about being sexually intimate?"
Query!
Timepoint [40]
0
0
Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177
Query!
Secondary outcome [41]
0
0
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Query!
Assessment method [41]
0
0
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. A treatment-emergent AE (TEAE) was defined as an AE that occurred from the date and time of the first dose of study drug through the date of last dose +30 days (or the day before initiation of a new antineoplastic treatment, whichever occurred first). AEs included both non-serious adverse events (AEs) and SAEs.
Query!
Timepoint [41]
0
0
From first dose of study drug to the last dose + 30 days (or the day before initiation of a new antineoplastic treatment, whichever occurred first) (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months)
Query!
Secondary outcome [42]
0
0
Number of Participants With Treatment-Emergent Adverse Events Greater Than or Equal to Grade 3, Based on National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE), Version 4.0
Query!
Assessment method [42]
0
0
An AE is any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. As per NCI CTCAE, Grade 3 events =medically significant but not immediately life-threatening, unacceptable or intolerable events, significantly interrupting usual daily activity, require systemic drug therapy/other treatment, Grade 4 events =participant to be in imminent danger of death. Grade 5 events =death. A treatment-emergent AE (TEAE) was defined as an AE that occurred from the date and time of the first dose of study drug through the date of last dose +30 days (or the day before initiation of a new antineoplastic treatment, whichever occurred first).Number of participants with AEs of any of the Grade 3 or above (Grade 4, 5) were reported.
Query!
Timepoint [42]
0
0
From first dose of study drug to the last dose + 30 days (or the day before initiation of a new antineoplastic treatment, whichever occurred first) (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months)
Query!
Secondary outcome [43]
0
0
Number of Participants With Discontinuations From Study Treatment Due to Adverse Events (AEs)
Query!
Assessment method [43]
0
0
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both non-serious adverse events (AEs) and SAEs.
Query!
Timepoint [43]
0
0
From first dose of study drug to the last dose + 30 days (or the day before initiation of a new antineoplastic treatment, whichever occurred first) (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months)
Query!
Secondary outcome [44]
0
0
Number of Participants With Increase of 2 or More National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) (Version 4.0) Toxicity Grades Above Baseline - Hematology
Query!
Assessment method [44]
0
0
Hematology parameters: Haemoglobin (grams per liter [g/L]); leukocytes (log 10 raised to power 9 per liter [10*9/L]); lymphocytes (log 10 raised to power 6 per liter [10*6/L]); neutrophils (log 10 raised to power 6 per liter [10*6/L]); platelets (log 10 raised to power 9 per litre [10*9/L]).
Query!
Timepoint [44]
0
0
From first dose of study drug to the last dose + 30 days (or the day before initiation of a new antineoplastic treatment, whichever occurred first) (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months)
Query!
Secondary outcome [45]
0
0
Number of Participants With Increase of 2 or More National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) (Version 4.0) Toxicity Grades Above Baseline - Chemistry
Query!
Assessment method [45]
0
0
Chemistry parameters: Alanine aminotransferase (units per liter [U/L]); albumin (g/L); alkaline phosphatase (U/L); bilirubin (micromoles per liter [umol/L]); calcium (millimoles per liter [mmol/L]); creatine kinase (U/L); creatinine (umol/L); glucose, magnesium, phosphate, potassium, sodium (mmol/L).
Query!
Timepoint [45]
0
0
From first dose of study drug to the last dose + 30 days (or the day before initiation of a new antineoplastic treatment, whichever occurred first) (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months)
Query!
Secondary outcome [46]
0
0
Number of Participants With Clinically Significant Vital Signs
Query!
Assessment method [46]
0
0
Vital signs included Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP) and heart rate.
Query!
Timepoint [46]
0
0
From first dose of study drug to the last dose + 30 days (or the day before initiation of a new antineoplastic treatment, whichever occurred first) (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months)
Query!
Eligibility
Key inclusion criteria
- Histologically or cytologically confirmed adenocarcinoma of the prostate without
neuroendocrine differentiation, signet cell, or small cell features;
- Ongoing androgen deprivation therapy with a gonadotropin-releasing hormone (GnRH)
agonist/antagonist or prior bilateral orchiectomy (medical or surgical castration);
- Testosterone = 50 ng/dL (= 1.73 nmol/L) at screening;
- Progressive disease on androgen deprivation therapy at enrollment;
- PSA and the screening PSA assessed by the central laboratory (central PSA) should be =
2 µg/L (2 ng/mL:
- PSA doubling time = 10 months;
- No prior or present evidence of metastatic disease;
- Asymptomatic prostate cancer;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
- Estimated life expectancy = 12 months.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Males
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
- Prior cytotoxic chemotherapy;
- Use of hormonal therapy or biologic therapy for prostate cancer (other than approved
bone targeting agents and GnRH agonist/antagonist therapy) or use of an
investigational agent within 4 weeks of randomization;
- Known or suspected brain metastasis or active leptomeningeal disease;
- History of another invasive cancer within 3 years of randomization;
- Absolute neutrophil count < 1000/µL, platelet count < 100,000/µL, or hemoglobin < 10
g/dL (6.2 mmol/L) at screening;
- Total bilirubin = 1.5 times the upper limit of normal;
- Creatinine > 2 mg/dL (177 µmol/L) at screening;
- Albumin < 3.0 g/dL (30 g/L) at screening;
- History of seizure or any condition that may predispose to seizure;
- Clinically significant cardiovascular disease;
- Gastrointestinal disorder affecting absorption;
- Major surgery within 4 weeks of randomization;
- Hypersensitivity reaction to the active pharmaceutical ingredient or any of the
capsule components, including Labrasol, butylated hydroxyanisole, and butylated
hydroxytoluene;
- Any concurrent disease, infection, or comorbid condition that interferes with the
ability of the patient to participate in the trial, which places the patient at undue
risk, or complicates the interpretation of data, in the opinion of the investigator or
medical monitor.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Active, not recruiting
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
31/10/2013
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
31/10/2024
Query!
Actual
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
1402
Query!
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,VIC
Query!
Recruitment hospital [1]
0
0
The Canberra Hospital - Garran
Query!
Recruitment hospital [2]
0
0
Border Medical Oncology Research Unit - Albury
Query!
Recruitment hospital [3]
0
0
The Border Cancer Hospital Dispensary - Albury
Query!
Recruitment hospital [4]
0
0
The Border Cancer Hospital - Albury
Query!
Recruitment hospital [5]
0
0
Sydney cancer centre - Concord
Query!
Recruitment hospital [6]
0
0
Epic pharmacy - Lismore
Query!
Recruitment hospital [7]
0
0
North Coast Cancer Institute - Lismore
Query!
Recruitment hospital [8]
0
0
Macquarie University Hospital - North Ryde
Query!
Recruitment hospital [9]
0
0
Macquarie University - North Ryde
Query!
Recruitment hospital [10]
0
0
Epic Pharmacy Port Macquarie base hospital - Port Macquarie
Query!
Recruitment hospital [11]
0
0
Mid North Coast Cancer Institute - Port Macquarie
Query!
Recruitment hospital [12]
0
0
Royal North Shore Hospital - St Leonards
Query!
Recruitment hospital [13]
0
0
The Tweed Hospital - Tweed Heads
Query!
Recruitment hospital [14]
0
0
Australian Clinical Trials - Wahroonga
Query!
Recruitment hospital [15]
0
0
Sydney Adventist Hospital - Wahroonga
Query!
Recruitment hospital [16]
0
0
Calvary Mater Newcastle - Waratah
Query!
Recruitment hospital [17]
0
0
Westmead Hospital - Westmead
Query!
Recruitment hospital [18]
0
0
Icon Cancer Care Wesley - Auchenflower
Query!
Recruitment hospital [19]
0
0
River City Pharmacy - APHS - Auchenflower
Query!
Recruitment hospital [20]
0
0
Icon Cancer Care Chermside - Chermside
Query!
Recruitment hospital [21]
0
0
Icon Cancer Care South Brisbane - South Brisbane
Query!
Recruitment hospital [22]
0
0
Integrated Clinical Oncology Network (ICON) - South Brisbane
Query!
Recruitment hospital [23]
0
0
Icon Cancer Care Southport - Southport
Query!
Recruitment hospital [24]
0
0
Tasman Oncology Research Pty Ltd - Southport
Query!
Recruitment hospital [25]
0
0
Princess Alexandra Hospital - Woolloongabba
Query!
Recruitment hospital [26]
0
0
Adelaide Cancer Centre - Kurralta Park
Query!
Recruitment hospital [27]
0
0
Ashford Cancer Centre Research - Kurralta park
Query!
Recruitment hospital [28]
0
0
Cancer Care SA Pty Ltd - Kurralta Park
Query!
Recruitment hospital [29]
0
0
Tenpharm Pty Ltd trading as EPIC Pharmacy Tennyson - Kurralta Park
Query!
Recruitment hospital [30]
0
0
Box Hill Hospital (Eastern health) - Box Hill
Query!
Recruitment hospital [31]
0
0
Eastern Clinical Research Unit (Eastern Health) - Box Hill
Query!
Recruitment hospital [32]
0
0
Cabrini Hospital Brighton - Brighton
Query!
Recruitment hospital [33]
0
0
Monash Medical Centre - Clayton
Query!
Recruitment hospital [34]
0
0
Austin Health, Austin Hospital - Heidelberg
Query!
Recruitment hospital [35]
0
0
Cabrini Hospital Malvern - Malvern
Query!
Recruitment hospital [36]
0
0
Cabrini Hospital- Education and Research Precinct - Malvern
Query!
Recruitment hospital [37]
0
0
Peter MacCallum Cancer Centre - Melbourne
Query!
Recruitment hospital [38]
0
0
Sunshine Hospital - St Albans
Query!
Recruitment postcode(s) [1]
0
0
2605 - Garran
Query!
Recruitment postcode(s) [2]
0
0
2640 - Albury
Query!
Recruitment postcode(s) [3]
0
0
2139 - Concord
Query!
Recruitment postcode(s) [4]
0
0
2480 - Lismore
Query!
Recruitment postcode(s) [5]
0
0
2109 - North Ryde
Query!
Recruitment postcode(s) [6]
0
0
2444 - Port Macquarie
Query!
Recruitment postcode(s) [7]
0
0
2065 - St Leonards
Query!
Recruitment postcode(s) [8]
0
0
2485 - Tweed Heads
Query!
Recruitment postcode(s) [9]
0
0
2076 - Wahroonga
Query!
Recruitment postcode(s) [10]
0
0
2298 - Waratah
Query!
Recruitment postcode(s) [11]
0
0
2145 - Westmead
Query!
Recruitment postcode(s) [12]
0
0
4066 - Auchenflower
Query!
Recruitment postcode(s) [13]
0
0
4032 - Chermside
Query!
Recruitment postcode(s) [14]
0
0
4101 - South Brisbane
Query!
Recruitment postcode(s) [15]
0
0
4215 - Southport
Query!
Recruitment postcode(s) [16]
0
0
4102 - Woolloongabba
Query!
Recruitment postcode(s) [17]
0
0
5037 - Kurralta Park
Query!
Recruitment postcode(s) [18]
0
0
5037 - Kurralta park
Query!
Recruitment postcode(s) [19]
0
0
3128 - Box Hill
Query!
Recruitment postcode(s) [20]
0
0
3186 - Brighton
Query!
Recruitment postcode(s) [21]
0
0
3168 - Clayton
Query!
Recruitment postcode(s) [22]
0
0
3084 - Heidelberg
Query!
Recruitment postcode(s) [23]
0
0
3144 - Malvern
Query!
Recruitment postcode(s) [24]
0
0
3000 - Melbourne
Query!
Recruitment postcode(s) [25]
0
0
3021 - St Albans
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Arizona
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
California
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Colorado
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Connecticut
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Florida
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Indiana
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Kansas
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Maryland
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Michigan
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Nebraska
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
New York
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
North Carolina
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Ohio
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Oregon
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
Pennsylvania
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
South Carolina
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
Tennessee
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
Texas
Query!
Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
Virginia
Query!
Country [20]
0
0
Argentina
Query!
State/province [20]
0
0
Buenos Aires
Query!
Country [21]
0
0
Argentina
Query!
State/province [21]
0
0
Santa FE
Query!
Country [22]
0
0
Argentina
Query!
State/province [22]
0
0
Cordoba
Query!
Country [23]
0
0
Argentina
Query!
State/province [23]
0
0
La Rioja
Query!
Country [24]
0
0
Austria
Query!
State/province [24]
0
0
Upper Austria
Query!
Country [25]
0
0
Austria
Query!
State/province [25]
0
0
Vienna
Query!
Country [26]
0
0
Belgium
Query!
State/province [26]
0
0
West-vlaanderen
Query!
Country [27]
0
0
Belgium
Query!
State/province [27]
0
0
Bruxelles
Query!
Country [28]
0
0
Belgium
Query!
State/province [28]
0
0
Gent
Query!
Country [29]
0
0
Belgium
Query!
State/province [29]
0
0
Leuven
Query!
Country [30]
0
0
Belgium
Query!
State/province [30]
0
0
Liege
Query!
Country [31]
0
0
Brazil
Query!
State/province [31]
0
0
Bahia
Query!
Country [32]
0
0
Brazil
Query!
State/province [32]
0
0
Parana
Query!
Country [33]
0
0
Brazil
Query!
State/province [33]
0
0
RIO Grande DO SUL
Query!
Country [34]
0
0
Brazil
Query!
State/province [34]
0
0
RJ
Query!
Country [35]
0
0
Brazil
Query!
State/province [35]
0
0
SAO Paulo
Query!
Country [36]
0
0
Brazil
Query!
State/province [36]
0
0
SP
Query!
Country [37]
0
0
Brazil
Query!
State/province [37]
0
0
Rio de Janeiro
Query!
Country [38]
0
0
Canada
Query!
State/province [38]
0
0
Alberta
Query!
Country [39]
0
0
Canada
Query!
State/province [39]
0
0
British Columbia
Query!
Country [40]
0
0
Canada
Query!
State/province [40]
0
0
Manitoba
Query!
Country [41]
0
0
Canada
Query!
State/province [41]
0
0
Nova Scotia
Query!
Country [42]
0
0
Canada
Query!
State/province [42]
0
0
Ontario
Query!
Country [43]
0
0
Canada
Query!
State/province [43]
0
0
Quebec
Query!
Country [44]
0
0
Chile
Query!
State/province [44]
0
0
Santiago
Query!
Country [45]
0
0
Chile
Query!
State/province [45]
0
0
Temuco
Query!
Country [46]
0
0
Chile
Query!
State/province [46]
0
0
Vina del Mar
Query!
Country [47]
0
0
China
Query!
State/province [47]
0
0
Beijing
Query!
Country [48]
0
0
China
Query!
State/province [48]
0
0
Chongqing
Query!
Country [49]
0
0
China
Query!
State/province [49]
0
0
Guangdong
Query!
Country [50]
0
0
China
Query!
State/province [50]
0
0
Hubei
Query!
Country [51]
0
0
China
Query!
State/province [51]
0
0
Jiangsu
Query!
Country [52]
0
0
China
Query!
State/province [52]
0
0
Shandong
Query!
Country [53]
0
0
China
Query!
State/province [53]
0
0
Shanghai
Query!
Country [54]
0
0
China
Query!
State/province [54]
0
0
Shanxi
Query!
Country [55]
0
0
China
Query!
State/province [55]
0
0
Zhejiang
Query!
Country [56]
0
0
China
Query!
State/province [56]
0
0
Hong Kong
Query!
Country [57]
0
0
China
Query!
State/province [57]
0
0
Tianjin
Query!
Country [58]
0
0
Denmark
Query!
State/province [58]
0
0
Norrebro
Query!
Country [59]
0
0
Denmark
Query!
State/province [59]
0
0
N
Query!
Country [60]
0
0
Denmark
Query!
State/province [60]
0
0
Arhus N
Query!
Country [61]
0
0
Denmark
Query!
State/province [61]
0
0
Copenhagen
Query!
Country [62]
0
0
Denmark
Query!
State/province [62]
0
0
Frederiksberg
Query!
Country [63]
0
0
Denmark
Query!
State/province [63]
0
0
Herlev
Query!
Country [64]
0
0
Denmark
Query!
State/province [64]
0
0
Odense C
Query!
Country [65]
0
0
Denmark
Query!
State/province [65]
0
0
Vejle
Query!
Country [66]
0
0
Finland
Query!
State/province [66]
0
0
Helsinki
Query!
Country [67]
0
0
Finland
Query!
State/province [67]
0
0
Oulu
Query!
Country [68]
0
0
Finland
Query!
State/province [68]
0
0
Pori
Query!
Country [69]
0
0
Finland
Query!
State/province [69]
0
0
Tampere
Query!
Country [70]
0
0
France
Query!
State/province [70]
0
0
Alsace
Query!
Country [71]
0
0
France
Query!
State/province [71]
0
0
Bas-rhin
Query!
Country [72]
0
0
France
Query!
State/province [72]
0
0
Paris
Query!
Country [73]
0
0
France
Query!
State/province [73]
0
0
Rhone
Query!
Country [74]
0
0
France
Query!
State/province [74]
0
0
VAL DE Marne
Query!
Country [75]
0
0
France
Query!
State/province [75]
0
0
Angers Cedex 2
Query!
Country [76]
0
0
France
Query!
State/province [76]
0
0
Avignon, Cedex 9
Query!
Country [77]
0
0
France
Query!
State/province [77]
0
0
Bordeaux Cedex
Query!
Country [78]
0
0
France
Query!
State/province [78]
0
0
Brest
Query!
Country [79]
0
0
France
Query!
State/province [79]
0
0
Colmar Cedex
Query!
Country [80]
0
0
France
Query!
State/province [80]
0
0
Colmar
Query!
Country [81]
0
0
France
Query!
State/province [81]
0
0
Dijon
Query!
Country [82]
0
0
France
Query!
State/province [82]
0
0
Le Mans,Cedex
Query!
Country [83]
0
0
France
Query!
State/province [83]
0
0
Lille
Query!
Country [84]
0
0
France
Query!
State/province [84]
0
0
Lyon Cedex 03
Query!
Country [85]
0
0
France
Query!
State/province [85]
0
0
Lyon Cedex
Query!
Country [86]
0
0
France
Query!
State/province [86]
0
0
Lyon
Query!
Country [87]
0
0
France
Query!
State/province [87]
0
0
Marseille
Query!
Country [88]
0
0
France
Query!
State/province [88]
0
0
Montpellier Cedex
Query!
Country [89]
0
0
France
Query!
State/province [89]
0
0
Paris, Cedex 15
Query!
Country [90]
0
0
France
Query!
State/province [90]
0
0
Pierre Benite
Query!
Country [91]
0
0
France
Query!
State/province [91]
0
0
Poitiers, Cedex
Query!
Country [92]
0
0
France
Query!
State/province [92]
0
0
Saint-Herblain Cedex
Query!
Country [93]
0
0
France
Query!
State/province [93]
0
0
Toulouse Cedex 3
Query!
Country [94]
0
0
France
Query!
State/province [94]
0
0
Toulouse Cedex 9
Query!
Country [95]
0
0
France
Query!
State/province [95]
0
0
Toulouse
Query!
Country [96]
0
0
Germany
Query!
State/province [96]
0
0
Baden-wuerttemberg
Query!
Country [97]
0
0
Germany
Query!
State/province [97]
0
0
Baden-wurttemberg
Query!
Country [98]
0
0
Germany
Query!
State/province [98]
0
0
Niedersachsen
Query!
Country [99]
0
0
Germany
Query!
State/province [99]
0
0
Nordrhein-westfalen
Query!
Country [100]
0
0
Germany
Query!
State/province [100]
0
0
Saxony
Query!
Country [101]
0
0
Germany
Query!
State/province [101]
0
0
Berlin
Query!
Country [102]
0
0
Germany
Query!
State/province [102]
0
0
Hamburg
Query!
Country [103]
0
0
Germany
Query!
State/province [103]
0
0
Kirchheim
Query!
Country [104]
0
0
Greece
Query!
State/province [104]
0
0
Crete
Query!
Country [105]
0
0
Greece
Query!
State/province [105]
0
0
Athens
Query!
Country [106]
0
0
Greece
Query!
State/province [106]
0
0
Larissa
Query!
Country [107]
0
0
Greece
Query!
State/province [107]
0
0
Patra
Query!
Country [108]
0
0
Greece
Query!
State/province [108]
0
0
Thessaloniki
Query!
Country [109]
0
0
Hong Kong
Query!
State/province [109]
0
0
Hong Kong
Query!
Country [110]
0
0
Hong Kong
Query!
State/province [110]
0
0
Shatin
Query!
Country [111]
0
0
Italy
Query!
State/province [111]
0
0
FC
Query!
Country [112]
0
0
Italy
Query!
State/province [112]
0
0
Cremona
Query!
Country [113]
0
0
Italy
Query!
State/province [113]
0
0
Faenza (RA)
Query!
Country [114]
0
0
Italy
Query!
State/province [114]
0
0
Lugo (RA)
Query!
Country [115]
0
0
Italy
Query!
State/province [115]
0
0
Meldola (FC)
Query!
Country [116]
0
0
Italy
Query!
State/province [116]
0
0
Milano
Query!
Country [117]
0
0
Italy
Query!
State/province [117]
0
0
Modena
Query!
Country [118]
0
0
Italy
Query!
State/province [118]
0
0
Napoli
Query!
Country [119]
0
0
Italy
Query!
State/province [119]
0
0
Orbassano (TO)
Query!
Country [120]
0
0
Italy
Query!
State/province [120]
0
0
Padova
Query!
Country [121]
0
0
Italy
Query!
State/province [121]
0
0
Ravenna
Query!
Country [122]
0
0
Italy
Query!
State/province [122]
0
0
Roma
Query!
Country [123]
0
0
Italy
Query!
State/province [123]
0
0
Trento
Query!
Country [124]
0
0
Korea, Republic of
Query!
State/province [124]
0
0
Gyeonggi-do
Query!
Country [125]
0
0
Korea, Republic of
Query!
State/province [125]
0
0
Jeonnam
Query!
Country [126]
0
0
Korea, Republic of
Query!
State/province [126]
0
0
Incheon
Query!
Country [127]
0
0
Korea, Republic of
Query!
State/province [127]
0
0
Seoul
Query!
Country [128]
0
0
Malaysia
Query!
State/province [128]
0
0
Kuala Lumpur
Query!
Country [129]
0
0
Malaysia
Query!
State/province [129]
0
0
Sarawak
Query!
Country [130]
0
0
Malaysia
Query!
State/province [130]
0
0
Selangor Darul Ehsan
Query!
Country [131]
0
0
Netherlands
Query!
State/province [131]
0
0
AZ
Query!
Country [132]
0
0
Netherlands
Query!
State/province [132]
0
0
Noord-brabant
Query!
Country [133]
0
0
Netherlands
Query!
State/province [133]
0
0
Amsterdam
Query!
Country [134]
0
0
Netherlands
Query!
State/province [134]
0
0
Dordrecht
Query!
Country [135]
0
0
Netherlands
Query!
State/province [135]
0
0
Groningen
Query!
Country [136]
0
0
Netherlands
Query!
State/province [136]
0
0
Nijmegen
Query!
Country [137]
0
0
New Zealand
Query!
State/province [137]
0
0
Canterbury
Query!
Country [138]
0
0
New Zealand
Query!
State/province [138]
0
0
Manawatu
Query!
Country [139]
0
0
New Zealand
Query!
State/province [139]
0
0
Auckland
Query!
Country [140]
0
0
New Zealand
Query!
State/province [140]
0
0
Hamilton
Query!
Country [141]
0
0
Poland
Query!
State/province [141]
0
0
Gdansk
Query!
Country [142]
0
0
Poland
Query!
State/province [142]
0
0
Kielce
Query!
Country [143]
0
0
Poland
Query!
State/province [143]
0
0
Krakow
Query!
Country [144]
0
0
Poland
Query!
State/province [144]
0
0
Lublin
Query!
Country [145]
0
0
Poland
Query!
State/province [145]
0
0
Slupsk
Query!
Country [146]
0
0
Poland
Query!
State/province [146]
0
0
Wroclaw
Query!
Country [147]
0
0
Russian Federation
Query!
State/province [147]
0
0
Moscow
Query!
Country [148]
0
0
Russian Federation
Query!
State/province [148]
0
0
Saint-Petersburg
Query!
Country [149]
0
0
Russian Federation
Query!
State/province [149]
0
0
Ufa
Query!
Country [150]
0
0
Serbia
Query!
State/province [150]
0
0
Belgrade
Query!
Country [151]
0
0
Singapore
Query!
State/province [151]
0
0
Singapore
Query!
Country [152]
0
0
Slovakia
Query!
State/province [152]
0
0
Banska Bystrica
Query!
Country [153]
0
0
Slovakia
Query!
State/province [153]
0
0
Bratislava
Query!
Country [154]
0
0
Slovakia
Query!
State/province [154]
0
0
Kosice
Query!
Country [155]
0
0
Slovakia
Query!
State/province [155]
0
0
Martin
Query!
Country [156]
0
0
Slovakia
Query!
State/province [156]
0
0
Nitra
Query!
Country [157]
0
0
Slovakia
Query!
State/province [157]
0
0
Presov
Query!
Country [158]
0
0
Slovakia
Query!
State/province [158]
0
0
Ruzomberok
Query!
Country [159]
0
0
Slovakia
Query!
State/province [159]
0
0
Skalica
Query!
Country [160]
0
0
Slovakia
Query!
State/province [160]
0
0
Trnava
Query!
Country [161]
0
0
Slovakia
Query!
State/province [161]
0
0
Zilina
Query!
Country [162]
0
0
Spain
Query!
State/province [162]
0
0
A Coruna
Query!
Country [163]
0
0
Spain
Query!
State/province [163]
0
0
Baleares
Query!
Country [164]
0
0
Spain
Query!
State/province [164]
0
0
Barcelona
Query!
Country [165]
0
0
Spain
Query!
State/province [165]
0
0
Cataluna
Query!
Country [166]
0
0
Spain
Query!
State/province [166]
0
0
Navarra
Query!
Country [167]
0
0
Spain
Query!
State/province [167]
0
0
Madrid
Query!
Country [168]
0
0
Sweden
Query!
State/province [168]
0
0
Goteborg
Query!
Country [169]
0
0
Sweden
Query!
State/province [169]
0
0
Malmo
Query!
Country [170]
0
0
Sweden
Query!
State/province [170]
0
0
Molnlycke
Query!
Country [171]
0
0
Sweden
Query!
State/province [171]
0
0
Solna
Query!
Country [172]
0
0
Sweden
Query!
State/province [172]
0
0
Stockholm
Query!
Country [173]
0
0
Sweden
Query!
State/province [173]
0
0
Umea
Query!
Country [174]
0
0
Sweden
Query!
State/province [174]
0
0
Örebro
Query!
Country [175]
0
0
Taiwan
Query!
State/province [175]
0
0
Chiayi County
Query!
Country [176]
0
0
Taiwan
Query!
State/province [176]
0
0
Kaohsiung
Query!
Country [177]
0
0
Taiwan
Query!
State/province [177]
0
0
Keelung City
Query!
Country [178]
0
0
Taiwan
Query!
State/province [178]
0
0
Taichung
Query!
Country [179]
0
0
Taiwan
Query!
State/province [179]
0
0
Tainan City
Query!
Country [180]
0
0
Taiwan
Query!
State/province [180]
0
0
Taipei
Query!
Country [181]
0
0
Taiwan
Query!
State/province [181]
0
0
Taoyuan County
Query!
Country [182]
0
0
Thailand
Query!
State/province [182]
0
0
Chiang MAI
Query!
Country [183]
0
0
Thailand
Query!
State/province [183]
0
0
Songkla
Query!
Country [184]
0
0
Thailand
Query!
State/province [184]
0
0
Bangkok
Query!
Country [185]
0
0
Turkey
Query!
State/province [185]
0
0
Adana
Query!
Country [186]
0
0
Turkey
Query!
State/province [186]
0
0
Ankara
Query!
Country [187]
0
0
Turkey
Query!
State/province [187]
0
0
Istanbul
Query!
Country [188]
0
0
Turkey
Query!
State/province [188]
0
0
Izmir
Query!
Country [189]
0
0
Turkey
Query!
State/province [189]
0
0
Manisa
Query!
Country [190]
0
0
Ukraine
Query!
State/province [190]
0
0
Chernivtsi
Query!
Country [191]
0
0
Ukraine
Query!
State/province [191]
0
0
Dnipropetrovsk
Query!
Country [192]
0
0
Ukraine
Query!
State/province [192]
0
0
Kharkiv
Query!
Country [193]
0
0
Ukraine
Query!
State/province [193]
0
0
Kyiv
Query!
Country [194]
0
0
Ukraine
Query!
State/province [194]
0
0
Uzhgorod
Query!
Country [195]
0
0
Ukraine
Query!
State/province [195]
0
0
Zaporizhzhia
Query!
Country [196]
0
0
United Kingdom
Query!
State/province [196]
0
0
Middlesex
Query!
Country [197]
0
0
United Kingdom
Query!
State/province [197]
0
0
Northern Ireland
Query!
Country [198]
0
0
United Kingdom
Query!
State/province [198]
0
0
Surrey
Query!
Country [199]
0
0
United Kingdom
Query!
State/province [199]
0
0
Tyne and Wear
Query!
Country [200]
0
0
United Kingdom
Query!
State/province [200]
0
0
Birmingham
Query!
Country [201]
0
0
United Kingdom
Query!
State/province [201]
0
0
Bristol
Query!
Country [202]
0
0
United Kingdom
Query!
State/province [202]
0
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Cambridge
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United Kingdom
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London
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United Kingdom
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Manchester
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Country [205]
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United Kingdom
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Oxford
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Pfizer
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Address
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Other collaborator category [1]
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Commercial sector/Industry
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Name [1]
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Astellas Pharma Inc
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Address [1]
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Other collaborator category [2]
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Commercial sector/Industry
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Name [2]
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Medivation LLC, a wholly owned subsidiary of Pfizer Inc.
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Address [2]
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to assess the safety and efficacy of enzalutamide in patients
with non metastatic prostate cancer.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02003924
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Pfizer Pfizer CT.gov Call Center
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Pfizer
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Contact person for public queries
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02003924
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