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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/NCT00974311
Registration number
NCT00974311
Ethics application status
Date submitted
9/09/2009
Date registered
10/09/2009
Date last updated
11/12/2018
Titles & IDs
Public title
Safety and Efficacy Study of MDV3100 in Patients With Castration-Resistant Prostate Cancer Who Have Been Previously Treated With Docetaxel-based Chemotherapy
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Scientific title
Affirm: A Multinational Phase 3, Randomized, Double-blind, Placebo-controlled Efficacy And Safety Study Of Oral Mdv3100 In Patients With Progressive Castration-resistant Prostate Cancer Previously Treated With Docetaxel Based Chemotherapy
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Secondary ID [1]
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2009-013174-41
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Secondary ID [2]
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CRPC2
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Universal Trial Number (UTN)
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Trial acronym
AFFIRM
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Castration-Resistant Prostate Cancer
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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
Experimental: Enzalutamide - Formerly MDV3100
Placebo Comparator: Placebo -
Treatment: Drugs: Enzalutamide
MDV3100, 160 mg orally per day
Treatment: Drugs: Placebo
Placebo comparator
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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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Overall Survival
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Assessment method [1]
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Survival was defined as time from randomization to death due to any cause. The duration of overall survival was right-censored for participants who were lost to follow-up since randomization or not known to have died at the data analysis cut-off date (this included participants who were known to have died after the data analysis cut-off date).
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Timepoint [1]
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During study period (up to 101 months)
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Secondary outcome [1]
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Radiographic Progression-free Survival
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Assessment method [1]
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Radiographic progression-free survival was defined as time from randomization to the earliest objective evidence of radiographic progression or death due to any cause. Participants were assessed for objective disease progression at regularly scheduled visits. The consensus guidelines of the Prostate Cancer Clinical Trials Working Group 2 were taken into consideration for the determination of disease progression. Radiographic disease progression was defined by Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 for soft tissue disease, or the appearance of two or more new bone lesions on bone scan. Progression at the first scheduled reassessment at Week 13 required a confirmatory scan 6 or more weeks later. Participants who did not reach the endpoint were right censored at their last assessment.
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Timepoint [1]
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During DB phase (up to 24 months)
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Secondary outcome [2]
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Time to First Skeletal-related Event
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Assessment method [2]
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The time to first skeletal-related event was defined as time from randomization to the occurrence of the first skeletal-related event. Participants were assessed for skeletal-related events at regularly scheduled visits. A skeletal-related event was defined as radiation therapy or surgery to bone, pathologic bone fracture, spinal cord compression, or change of antineoplastic therapy to treat bone pain. Participants who did not reach the endpoint were right censored at their last assessment.
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Timepoint [2]
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During DB Phase (up to 24 months)
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Secondary outcome [3]
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Percentage of Participants Who Were Responders for Functional Assessment of Cancer Therapy-Prostate (FACT-P)
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Assessment method [3]
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The FACT-P was a 39-item participant questionnaire which assessed physical well-being (7 items), social/family well-being (7 items), emotional well-being (6 items), functional well-being (7 items), and additional prostate cancer specific concerns (12 items). All items were scored from 0 (not at all) to 4 (very much). The sum of scores on all 5 domains constitutes the global FACT-P. The global/total FACT-P score ranged from 0 (worst) to 156 (best), higher scores indicate better health status. Responders were those participants who had a 10-point improvement in their total FACT-P score, as compared with baseline, on two consecutive measurements obtained at least 3 weeks apart.
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Timepoint [3]
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Baseline up to 24 months
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Secondary outcome [4]
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Time to Prostate-specific Antigen (PSA) Progression
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Assessment method [4]
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Time to PSA progression was defined as time from randomization to PSA progression. Participants who did not reach the endpoint were right censored at their last assessment or for participants with no post-baseline PSA assessment, date of randomization. For participants with PSA declines at Week 13, the PSA progression date was defined as the date that a >=25% increase and an absolute increase of >=2 nanogram per milliliter (ng/mL) above the nadir was documented, which was confirmed by a second consecutive value obtained 3 or more weeks later (required only if PSA progression did not occur at last PSA assessment). For participants with no PSA declines at Week 13, PSA progression date was defined as the date that a >=25% increase and an absolute increase of >=2 ng/mL above the baseline was documented, which was confirmed by a second consecutive value 3 or more weeks later (required only if PSA progression did not occur at last PSA assessment).
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Timepoint [4]
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Baseline and at every study visit from Week 13 while on study drug (up to 24 months)
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Secondary outcome [5]
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Percentage of Participants With Pain Palliation
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Assessment method [5]
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The proportion of participants with pain palliation was assessed for participants with a stable and sufficient pain burden at study entry. Pain burden was measured by question #3 of the Brief Pain Inventory (Short Form). This scale measures pain on a 0 to 10 scale with 0 indicating no pain and 10 indicating pain as bad as you can imagine. Pain palliation at Week 13 was determined for the proportion of men with baseline bone metastasis(es) who had baseline pain attributable to the metastasis(es). Palliation was defined as >=30% reduction in average pain score at Week 13 compared to baseline without a >=30% increase in analgesic use.
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Timepoint [5]
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Baseline up to 24 months
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Secondary outcome [6]
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Percentage of Participants With Prostate Specific Antigen (PSA) Response
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Assessment method [6]
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Participants were evaluable for PSA response rate if they had a PSA level measured at baseline and at least 1 post-baseline assessment. Both PSA responses of > 50% and > 90% were determined. PSA responses required confirmation with a subsequent assessment that was conducted at least 3 weeks later.
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Timepoint [6]
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During DB phase (up to 24 months)
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Secondary outcome [7]
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Percentage of Participants With Soft-tissue Objective Response
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Assessment method [7]
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The best overall soft tissue response as assessed using RECIST v1.1 during the study was summarized using the investigators' response assessments and also the derived response assessments by treatment group. Only participants with measurable soft tissue disease at screening were included in this analysis. Participants with measurable disease at screening are participants who had at least 1 target lesion identified per RECIST v1.1 at screening. Percentage of participants summarizes the number of participants with complete or partial objective response (%). Soft Tissue assessment based on Eisenhauer EA, Therasse P, Bogaerts J et al. New response evaluation criteria in solid tumours: Revised RECIST guideline (version 1.1). Eur J Cancer 2009; 45:228-247.
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Timepoint [7]
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During DB phase (up to 24 months)
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Secondary outcome [8]
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European Quality of Life Five-Domain (EQ-5D) Scale
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Assessment method [8]
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EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility or index score. Five parameters (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) were assessed on 3-point categorical scale (1= no problems, 2= some/moderate problems and 3= severe problem). Score were transformed and resulted in a total EQ-5D score range of 0 (worst imaginable health state) to 100 (best imaginable health state), with higher scores indicating better health and quality of life.
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Timepoint [8]
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Week 13
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Secondary outcome [9]
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Percentage of Participants With Circulating Tumor Cell (CTC) Conversion
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Assessment method [9]
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CTC conversion was assessed for participants with baseline CTC counts of greater than or equal to (>=) 5 cells per 7.5 milliliter (mL) of blood. A CTC conversion was defined as a decline in the CTC count to less than (<) 5 cells per 7.5 mL of blood. In this outcome measure percentage of participants with CTC conversion was reported.
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Timepoint [9]
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Baseline up to 24 months
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Eligibility
Key inclusion criteria
- Progressive prostate cancer
- Medical or surgical castration with testosterone less than 50 ng/dl
- One or two prior chemotherapy regimens. At least one chemotherapy regimen must have
contained docetaxel
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Adequate bone marrow, hepatic, and renal function
- Able to swallow the study drug and comply with study requirements
- Informed consent
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Males
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Metastases in the brain or active epidural disease
- Another malignancy within the previous 5 years
- Clinically significant cardiovascular disease
- Gastrointestinal disorder affecting absorption
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
30/09/2009
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
2/11/2017
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Sample size
Target
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Accrual to date
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Final
1199
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,VIC,WA
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Recruitment hospital [1]
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North Coast Cancer Institute - Coffs Harbour
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Sydney Cancer Centre - Concord
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Mid North Coast Diagnostic Imaging - Port Macquarie
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Port Macquarie Base Hospital Pharmacy - Port Macquarie
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Port Macquarie Base Hospital - Port Macquarie
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Recruitment hospital [6]
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Prince of Wales Hospital, Department of Medical Oncology - Randwick
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Recruitment hospital [7]
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The Tweed Hospital - Tweed Heads
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Recruitment hospital [8]
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PRP Diagnostic Imaging - Wentworthville
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Recruitment hospital [9]
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Sydney West Cancer Trials Centre, Department of Medical Oncology - Westmead
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Recruitment hospital [10]
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River City Pharmacy - Auchenflower
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Recruitment hospital [11]
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Heart Care Partners - Auchenflower
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Icon Cancer Care Wesley - Auchenflower
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Icon Cancer Care Chermside - Chermside
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Recruitment hospital [14]
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Southern X-Ray Chermside - Chermside
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Cancer Care Services - Herston
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Icon Cancer Foundation - Milton
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Icon Cancer Care South Brisbane - South Brisbane
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Mater Private Cardiology - South Brisbane
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Queensland X-Ray - South Brisbane
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XRadiology - Toowong
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Department of Medical Oncology - Adelaide
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Royal Hobart Hospital - Hobart
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Recruitment hospital [23]
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St. Vincent's Hospital Melbourne - Fitzroy
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Recruitment hospital [24]
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Peninsula Oncology Centre - Frankston
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Austin Hospital - Heidelberg
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Sir Charles Gairdner Hospital, Department of Medical Oncology - Nedlands
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Recruitment hospital [27]
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60 Eleanor St - Footscray
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Recruitment hospital [28]
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Western Hospital - Footscray
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Recruitment hospital [29]
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The Royal Melbourne Hospital - Victoria
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Recruitment postcode(s) [1]
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2450 - Coffs Harbour
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Recruitment postcode(s) [2]
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2139 - Concord
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Recruitment postcode(s) [3]
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2444 - Port Macquarie
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Recruitment postcode(s) [4]
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2031 - Randwick
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Recruitment postcode(s) [5]
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2485 - Tweed Heads
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Recruitment postcode(s) [6]
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2145 - Wentworthville
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Recruitment postcode(s) [7]
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2145 - Westmead
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Recruitment postcode(s) [8]
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4064 - Auchenflower
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Recruitment postcode(s) [9]
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4066 - Auchenflower
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Recruitment postcode(s) [10]
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4032 - Chermside
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Recruitment postcode(s) [11]
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4029 - Herston
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Recruitment postcode(s) [12]
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4064 - Milton
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Recruitment postcode(s) [13]
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4101 - South Brisbane
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4066 - Toowong
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Recruitment postcode(s) [15]
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5000 - Adelaide
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7000 - Hobart
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Recruitment postcode(s) [17]
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3065 - Fitzroy
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Recruitment postcode(s) [18]
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3199 - Frankston
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Recruitment postcode(s) [19]
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3084 - Heidelberg
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6009 - Nedlands
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Recruitment postcode(s) [21]
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3011 - Footscray
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Recruitment postcode(s) [22]
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3050 - Victoria
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Recruitment outside Australia
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Ciudad Autonoma de Buenos Aires
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Germany
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State/province [77]
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0
Mannheim
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Country [78]
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0
Germany
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State/province [78]
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Muenster
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Country [79]
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Germany
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State/province [79]
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Tuebingen
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Country [80]
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Italy
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Modena
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Country [81]
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Italy
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State/province [81]
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TO
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Country [82]
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Italy
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State/province [82]
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Cremona
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Country [83]
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Italy
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Rome
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Country [84]
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Netherlands
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State/province [84]
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Amsterdam
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Country [85]
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Netherlands
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State/province [85]
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Nijmegen
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Country [86]
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Netherlands
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State/province [86]
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Rotterdam
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Country [87]
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Poland
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State/province [87]
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Gdansk
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Country [88]
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Poland
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State/province [88]
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Grudziadz
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Country [89]
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Poland
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State/province [89]
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Lodz
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Country [90]
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Poland
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State/province [90]
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Slupsk
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Country [91]
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South Africa
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State/province [91]
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Durban
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Country [92]
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South Africa
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State/province [92]
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Port Elizabeth
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Country [93]
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South Africa
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State/province [93]
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Sandton
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Country [94]
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Spain
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State/province [94]
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Badalona
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Country [95]
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Spain
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State/province [95]
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Barcelona
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Country [96]
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Spain
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State/province [96]
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Madrid
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Country [97]
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Spain
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State/province [97]
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Pamplona
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Country [98]
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United Kingdom
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State/province [98]
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Middlesex
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Country [99]
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United Kingdom
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Surrey
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United Kingdom
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Belfast
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United Kingdom
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Birmingham
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United Kingdom
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State/province [102]
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Bristol
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Country [103]
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United Kingdom
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State/province [103]
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Cambridge
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United Kingdom
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State/province [104]
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Glasgow
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United Kingdom
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State/province [105]
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London
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Country [106]
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United Kingdom
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State/province [106]
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Manchester
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Country [107]
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United Kingdom
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State/province [107]
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Newcastle upon Tyne
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Country [108]
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United Kingdom
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State/province [108]
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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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0
Commercial sector/Industry
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Name [1]
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Astellas Pharma Inc
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0
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0
0
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Other collaborator category [2]
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0
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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0
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Ethics approval
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Summary
Brief summary
This is a phase 3 study to compare the clinical benefit of MDV3100 versus placebo in patients
with castration-resistant prostate cancer who have been previously treated with
docetaxel-based chemotherapy.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00974311
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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 scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00974311
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