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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05884398
Registration number
NCT05884398
Ethics application status
Date submitted
23/05/2023
Date registered
1/06/2023
Titles & IDs
Public title
A Study of an Intermittent ADT Approach With Apalutamide Monotherapy in Participants With mCSPC
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Scientific title
A Phase 3, Open-label, Randomized, Prospective Study of Apalutamide With Continued Versus Intermittent Androgen-Deprivation Therapy (ADT) Following PSA Response in Participants With Metastatic Castration-Sensitive Prostate Cancer (mCSPC)
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Secondary ID [1]
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56021927PCR3020
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Secondary ID [2]
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CR109327
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Universal Trial Number (UTN)
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Trial acronym
LIBERTAS
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Metastatic Castrate-sensitive Prostate Cancer
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Condition category
Condition code
Cancer
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Prostate
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Inflammatory and Immune System
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Allergies
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Apalutamide
Treatment: Drugs - Androgen-deprivation Therapy (ADT)
Experimental: Arm A (Intermittent ADT Group) - Participants with PSA level \<0.2 ng/mL after 6 months of treatment with Apalutamide and ADT during initial treatment phase, will enter main treatment phase and treated with apalutamide with intermittent ADT per protocol or followed up for at least 18 months from Day 1 of Cycle 7 (each cycle 28 days) or have discontinued the study, whichever occurs first.
Experimental: Arm B (Continuous ADT Group) - Participants with PSA level \<0.2 ng/mL after 6 months of treatment with Apalutamide and ADT during initial treatment phase, will enter main treatment phase and continue to receive apalutamide plus ADT or followed up for at least 18 months from Day 1 of Cycle 7 (each cycle 28 days) or have discontinued the study, whichever occurs first.
Treatment: Drugs: Apalutamide
Apalutamide will be administered orally from Day 1 of Cycle 1 till 6 months in initial treatment phase and then in main treatment phase from Day 1 of Cycle 7 up to at least 18 months.
Treatment: Drugs: Androgen-deprivation Therapy (ADT)
The choice of ADT will be at discretion of the Investigator. Dosing (dose and frequency of administration) will be consistent with the prescribing information.
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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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Percentage of Participants With 18-Months Radiographic Progression-free Survival (rPFS)
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Assessment method [1]
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rPFS is defined as the duration from the date of randomization to the date of first documentation of confirmed radiographic progressive disease or death due to any cause, whichever occurs first. rPFS will be assessed by investigators using conventional imaging (computed tomography \[CT\]/magnetic resonance imaging \[MRI\] and 99mTc bone scans).
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Timepoint [1]
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From randomization (Day 1 of Cycle 7) up to 18 months
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Primary outcome [2]
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Percent Change From Randomization in Severity of Adjusted Hot Flash Score at 18 Months
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Assessment method [2]
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Severity adjusted hot flash score will be calculated from the hot flash diary which will be daily filled by the participants.
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Timepoint [2]
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From randomization (Day 1 of Cycle 7) up to 18 months
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Secondary outcome [1]
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Mean Percentage Changes From Randomization in Severity Adjusted Hot Flash Score and Hot Flash Frequency
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Assessment method [1]
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Severity adjusted hot flash score and hot flash frequency will be calculated from the hot flash diary which will be daily filled by the participants.
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Timepoint [1]
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From randomization (Day 1 of Cycle 7), up to 3 years 3 months
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Secondary outcome [2]
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Second Progression-free Survival (PFS2)
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Assessment method [2]
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PFS2 is defined as the duration from the date of randomization to the first occurrence of investigator-determined disease progression on the first subsequent therapy after study drug discontinuation or death, whichever occurs first.
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Timepoint [2]
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From randomization (Day 1 of Cycle 7) up to 3 years 3 months
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Secondary outcome [3]
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Overall Survival (OS)
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Assessment method [3]
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Overall survival time is defined as the duration from the date of randomization to the date of death from any cause.
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Timepoint [3]
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From randomization (Day 1 of Cycle 7) up to 3 years 3 months
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Secondary outcome [4]
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Prostate Cancer-specific Survival
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Assessment method [4]
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Prostate cancer-specific survival is defined as the duration from the date of randomization to the date of death from any cause.
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Timepoint [4]
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From randomization (Day 1 Cycle 7) up to 3 years 3 months
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Secondary outcome [5]
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Serum Prostate Specific Antigen (PSA) Evaluations
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Assessment method [5]
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Serum PSA evaluations will be measured according to Prostate Cancer Working Group 3 (PCWG3) criteria.
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Timepoint [5]
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From randomization (Day 1 of Cycle 7) up to 3 years 3 months
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Secondary outcome [6]
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Duration of Time on Androgen-deprivation Therapy (ADT)
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Assessment method [6]
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Duration of time on ADT will be reported for all participants.
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Timepoint [6]
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From randomization (Day 1 of Cycle 7) up to 3 years 3 months
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Secondary outcome [7]
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Time to First ADT Restart
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Assessment method [7]
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Time to first ADT restart will be reported.
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Timepoint [7]
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From randomization (Day 1 of Cycle 7) up to 3 years 3 months
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Secondary outcome [8]
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Duration of Time with Testosterone Level Less than (<) 50 nanograms per millilitre (ng/mL)
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Assessment method [8]
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Duration of time with testosterone level \<50 ng/mL will be reported.
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Timepoint [8]
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From randomization (Day 1 of Cycle 7) up to 3 years 3 months
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Secondary outcome [9]
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Time to Recovery of Testosterone >50 nanogram per decilitre (ng/dL)
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Assessment method [9]
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The testosterone recovery, defined as a serum testosterone \>50 ng/dL will be analyzed.
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Timepoint [9]
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From randomization (Day 1 of Cycle 7) up to 3 years 3 months
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Secondary outcome [10]
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Time to Recovery of Testosterone Greater Than or Equal (>=) Screening Testosterone Level
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Assessment method [10]
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Time to recovery of testosterone \>= screening testosterone level will be reported.
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Timepoint [10]
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From randomization (Day 1 of Cycle 7) up to 3 years 3 months
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Secondary outcome [11]
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Time to Testosterone Recovery to Normal Range (>270 ng/dL)
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Assessment method [11]
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Time to serum testosterone recovery to normal range (\>270 ng/dL) will be reported.
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Timepoint [11]
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From randomization (Day 1 of Cycle 7) up to 3 years 3 months
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Secondary outcome [12]
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Time to Metastatic Castration-resistant Prostate Cancer (mCRPC)
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Assessment method [12]
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Time to mCRPC will be reported.
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Timepoint [12]
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From randomization (Day 1 of Cycle 7) up to 3 years 3 months
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Secondary outcome [13]
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Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
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Assessment method [13]
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An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/ biological agent under study. An SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, leads to a congenital anomaly/birth defect in the offspring of a participant, or is an important medical event.
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Timepoint [13]
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Initial Treatment Phase: From Day 1 of Cycle 1 (each cycle 28 days) up to end of Cycle 6 (6 month); Main Treatment Phase: Day 1 of Cycle 7 up to end of study (up to 3 years 9 months)
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Secondary outcome [14]
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Number of Participants with Abnormal Clinical Laboratory Parameters
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Assessment method [14]
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Number of participants with abnormal clinical laboratory parameters (hematology, clinical chemistry) will be reported.
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Timepoint [14]
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From Cycle 1 Day 1 up to 3 years 9 months
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Secondary outcome [15]
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Number of Participants with Abnormal Vital Sign Parameters
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Assessment method [15]
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Number of participants with abnormal vital sign parameters (temperature, pulse/heart rate, respiratory rate, and blood pressure) will be reported.
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Timepoint [15]
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From Cycle 1 Day 1 up to 3 years 9 months
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Secondary outcome [16]
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Number of Participants with Abnormal Physical Examination Parameters
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Assessment method [16]
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Number of Participants with Abnormal physical examination parameters will be reported.
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Timepoint [16]
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From Cycle 1 Day 1 up to 3 years 9 months
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Secondary outcome [17]
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Hot Flash Related Daily Interference Score (HFRDIS)
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Assessment method [17]
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The HFRDIS is a 10-item scale assessing how much hot flashes interfered with various aspects of a participant's daily life. All items are rated on a 0-10 numerical rating scale with 0 anchored as "Do Not Interfere" and 10 as "Completely Interfere." A total score is computed by summing items. Higher scores indicate higher interference due to hot flashes and thus, greater impact on quality of life.
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Timepoint [17]
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Up to 3 years 9 months
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Secondary outcome [18]
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Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Score
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Assessment method [18]
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The EORTC-QLQ-C30 (Version 3), is a self-administered, 30-item questionnaire measuring the HRQoL of participants with cancer. The recall period for most items is the past week. EORTC-QLQ-C30 includes 5 functional scales (physical, role, cognitive, emotional, and social), 3 symptom scales (fatigue, pain, and nausea and vomiting), a global health status/quality of life scale, and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The item and scale scores are transformed to a 0 to 100 scale. A high scale score represents a higher response level. Thus, a high score for a functional scale represents a high/healthy level of functioning and a high score for the global health status represents high HRQoL, but a high score for a symptom scale/item represents a high level of symptomatology/problems.
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Timepoint [18]
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Baseline up to 3 years 9 months
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Secondary outcome [19]
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Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire -Prostate Cancer Module (EORTC-PR25) Questionnaire
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Assessment method [19]
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The EORTC-PR25 questionnaire is a supplement to the EORTC-QLQ-C30 questionnaire and is designed to assess symptoms related to prostate cancer, its treatment, and aspects of life related to this type of cancer.
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Timepoint [19]
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Baseline up to 3 years 9 months
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Secondary outcome [20]
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Change From Baseline in European Organization for the Research and Treatment of Cancer (EORTC) Customized Study Form
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Assessment method [20]
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EORTC customized study form will include 3 questions that are not included on the QLQ-30 or PR25 forms. The items assess rash, side effect burden, and dry mouth.
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Timepoint [20]
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Baseline up to 3 years 9 months
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Secondary outcome [21]
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Change From Baseline in Patient-Reported Outcomes Measurement Information System Cognitive Function (PROMIS-Cog) Questionnaire
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Assessment method [21]
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The PROMIS-Cog is a self-administered fixed-length questionnaire of 8 items from the PROMIS item bank relating to cognitive function. The raw domain scores are converted to standardized T-scores with a mean of 50 and a standard deviation of 10. Higher scores indicate better cognitive functioning.
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Timepoint [21]
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0
Baseline up to 3 years 9 months
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Secondary outcome [22]
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Change From Baseline in Memorial Anxiety Scale for Prostate Cancer (MAX-PC) Questionnaire
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Assessment method [22]
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The MAX-PC is a patient-reported questionnaire measuring prostate cancer specific anxiety. It consists of 18 items in 3 domains: It includes 11 items regarding prostate cancer anxiety, scored 0-33; 3 items regarding prostate-specific Antigen Anxiety, scored 0-9; and 4 items regarding fear of recurrence, scored 0-12. Total score ranges from 0-54 with higher scores indicating greater anxiety.
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Timepoint [22]
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Baseline up to 3 years 9 months
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Secondary outcome [23]
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Change From Baseline in Patient Health Questionnaire (PHQ-9) Questionnaire
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Assessment method [23]
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The PHQ-9 is self-administered, 9-item questionnaire measuring symptoms of depression. The recall period for all items is the past 2 weeks. The items include diminished interest or pleasure, depressed mood, insomnia/hypersomnia, fatigue or loss of energy, weight loss or weight gain/appetite loss or appetite gain, feelings of worthlessness, diminished concentration/indecisiveness, psychomotor agitation/retardation, and thoughts of death/suicide. Higher scores indicate more severe depressive symptoms.
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Timepoint [23]
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Baseline up to 3 years 9 months
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Secondary outcome [24]
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Change From Baseline in Patient Global Impression of Severity scale (PGIS) Questionnaire
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Assessment method [24]
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The PGIS is a self-administered, single item questionnaire measuring patients' impression of disease severity. Participants will be asked to rate their disease severity over the past 7 days using the following 5-point scale: 1 = None, 2 = Mild, 3 = Moderate, 4 = Severe, and 5 = Very severe. Higher scores indicate greater severity of fatigue.
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Timepoint [24]
0
0
Baseline up to 3 years 9 months
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Secondary outcome [25]
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Change From Baseline in Patient Global Impression of Change (PGIC) Questionnaire
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Assessment method [25]
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The PGIC is self-administered, single-item questionnaire measuring patients' impression of change in disease symptoms. Participants will be asked to rate their current symptoms as compared to when they started the study, using the following 7-point scale: 1 = Much better, 2 = Moderately better, 3 = A little better, 4 = No change, 5 = A little worse, 6 = Moderately worse, and 7 = Much worse. A higher PGIC score indicates greater worsening of symptoms.
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Timepoint [25]
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0
Baseline up to 3 years 9 months
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Secondary outcome [26]
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Time to Recovery From Baseline as Assessed by EORTC-QLQ-C30
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Assessment method [26]
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0
Time to recovery from baseline as assessed by EORTC-QLQ-C30 will be reported. The EORTC-QLQ-C30 (Version 3), is a self-administered, 30-item questionnaire measuring the HRQoL of participants with cancer. The recall period for most items is the past week. EORTC-QLQ-C30 includes 5 functional scales (physical, role, cognitive, emotional, and social), 3 symptom scales (fatigue, pain, and nausea and vomiting), a global health status/quality of life scale, and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The item and scale scores are transformed to a 0 to 100 scale. A high scale score represents a higher response level. Thus, a high score for a functional scale represents a high/healthy level of functioning and a high score for the global health status represents high HRQoL, but a high score for a symptom scale/item represents a high level of symptomatology/problems.
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Timepoint [26]
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Baseline up to 3 years 9 months
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Secondary outcome [27]
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Time to Recovery From Baseline as Assessed by EORTC-PR25
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Assessment method [27]
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Time to recovery from baseline as assessed by EORTC-PR25 will be reported. The EORTC-PR25 questionnaire is a supplement to the EORTC-QLQ-C30 questionnaire and is designed to assess symptoms related to prostate cancer, its treatment, and aspects of life related to this type of cancer.
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Timepoint [27]
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0
Baseline up to 3 years 9 months
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Secondary outcome [28]
0
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Time to Recovery From Baseline as Assessed by EORTC Customized Study Form
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Assessment method [28]
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Time to recovery from baseline as assessed by EORTC customized study form will be reported. EORTC customized study form will include 3 questions that are not included on the QLQ-30 or PR25 forms. The items assess rash, side effect burden, and dry mouth.
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Timepoint [28]
0
0
Baseline up to 3 years 9 months
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Secondary outcome [29]
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Time to Recovery From Baseline as Assessed by MAX-PC
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Assessment method [29]
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Time to recovery from baseline as assessed by MAX-PC will be reported. The MAX-PC is a patient-reported questionnaire measuring prostate cancer specific anxiety. It consists of 18 items in 3 domains: It includes 11 items regarding prostate cancer anxiety, scored 0-33; 3 items regarding prostate-specific Antigen Anxiety, scored 0-9; and 4 items regarding fear of recurrence, scored 0-12. Total score ranges from 0-54 with higher scores indicating greater anxiety.
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Timepoint [29]
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0
Baseline up to 3 years 9 months
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Secondary outcome [30]
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Time to Recovery From Baseline as Assessed by PHQ-9
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Assessment method [30]
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Time to recovery from baseline as assessed by PHQ-9 will be reported. The PHQ-9 is self-administered, 9-item questionnaire measuring symptoms of depression. The recall period for all items is the past 2 weeks. The items include diminished interest or pleasure, depressed mood, insomnia/hypersomnia, fatigue or loss of energy, weight loss or weight gain/appetite loss or appetite gain, feelings of worthlessness, diminished concentration/indecisiveness, psychomotor agitation/retardation, and thoughts of death/suicide. Higher scores indicate more severe depressive symptoms.
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Timepoint [30]
0
0
Baseline up to 3 years 9 months
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Secondary outcome [31]
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0
Time to Recovery From Baseline as Assessed by PGIS
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Assessment method [31]
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0
Time to recovery from baseline as assessed by PGIS will be reported. The PGIS is a self-administered, single item questionnaire measuring patients' impression of disease severity. Participants will be asked to rate their disease severity over the past 7 days using the following 5-point scale: 1 = None, 2 = Mild, 3 = Moderate, 4 = Severe, and 5 = Very severe. Higher scores indicate greater severity of fatigue.
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Timepoint [31]
0
0
Baseline up to 3 years 9 months
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Secondary outcome [32]
0
0
Time to Recovery From Baseline as Assessed by PGIC
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Assessment method [32]
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Time to recovery from baseline as assessed by PGIC will be reported. The PGIC is self-administered, single-item questionnaire measuring patients' impression of change in disease symptoms. Participants will be asked to rate their current symptoms as compared to when they started the study, using the following 7-point scale: 1 = Much better, 2 = Moderately better, 3 = A little better, 4 = No change, 5 = A little worse, 6 = Moderately worse, and 7 = Much worse. A higher PGIC score indicates greater worsening of symptoms.
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Timepoint [32]
0
0
Baseline up to 3 years and 9 months
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Secondary outcome [33]
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0
Time to Recovery From Baseline as Assessed by PROMIS-Cog
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Assessment method [33]
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0
Time to recovery from baseline as assessed by PROMIS-Cog will be reported. The PROMIS-Cog is a self-administered fixed-length questionnaire of 8 items from the PROMIS item bank relating to cognitive function. The raw domain scores are converted to standardized T-scores with a mean of 50 and a standard deviation of 10. Higher scores indicate better cognitive functioning.
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Timepoint [33]
0
0
Baseline up to 3 years 9 months
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Secondary outcome [34]
0
0
Time to Deterioration in EORTC-QLQ-C30 Over Time
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Assessment method [34]
0
0
Time to deterioration in EORTC-QLQ-C30 over time will be reported. The EORTC-QLQ-C30 (Version 3), is a self-administered, 30-item questionnaire measuring the HRQoL of participants with cancer. The recall period for most items is the past week. EORTC-QLQ-C30 includes 5 functional scales (physical, role, cognitive, emotional, and social), 3 symptom scales (fatigue, pain, and nausea and vomiting), a global health status/quality of life scale, and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The item and scale scores are transformed to a 0 to 100 scale. A high scale score represents a higher response level. Thus, a high score for a functional scale represents a high/healthy level of functioning and a high score for the global health status represents high HRQoL, but a high score for a symptom scale/item represents a high level of symptomatology/problems.
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Timepoint [34]
0
0
Up to 3 years 9 months
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Secondary outcome [35]
0
0
Time to Deterioration in EORTC-PR25 Over Time
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Assessment method [35]
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0
Time to deterioration in EORTC-PR25 over time will be reported. The EORTC-PR25 questionnaire is a supplement to the EORTC-QLQ-C30 questionnaire and is designed to assess symptoms related to prostate cancer, its treatment, and aspects of life related to this type of cancer.
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Timepoint [35]
0
0
Up to 3 years 9 months
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Secondary outcome [36]
0
0
Time to Deterioration in EORTC Customized Study Form Over Time
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Assessment method [36]
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0
Time to deterioration in EORTC Customized Study Form over time will be reported. EORTC customized study form will include 3 questions that are not included on the QLQ-30 or PR25 forms. The items assess rash, side effect burden, and dry mouth.
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Timepoint [36]
0
0
Up to 3 years 9 months
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Secondary outcome [37]
0
0
Time to Deterioration as per PROMIS-Cog Questionnaire Over Time
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Assessment method [37]
0
0
Time to deterioration as per PROMIS-Cog questionnaire over time will be reported. The PROMIS-Cog is a self-administered fixed-length questionnaire of 8 items from the PROMIS item bank relating to cognitive function. The raw domain scores are converted to standardized T-scores with a mean of 50 and a standard deviation of 10. Higher scores indicate better cognitive functioning.
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Timepoint [37]
0
0
Up to 3 years 9 months
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Secondary outcome [38]
0
0
Time to Deterioration in MAX-PC Questionnaire Over Time
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Assessment method [38]
0
0
Time to deterioration in MAX-PC questionnaire over time will be reported. The MAX-PC is a patient-reported questionnaire measuring prostate cancer specific anxiety. It consists of 18 items in 3 domains: It includes 11 items regarding prostate cancer anxiety, scored 0-33; 3 items regarding prostate-specific Antigen Anxiety, scored 0-9; and 4 items regarding fear of recurrence, scored 0-12. Total score ranges from 0-54 with higher scores indicating greater anxiety.
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Timepoint [38]
0
0
Up to 3 years 9 months
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Secondary outcome [39]
0
0
Time to Deterioration as per PHQ-9 Questionnaire Over Time
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Assessment method [39]
0
0
Time to deterioration as per PHQ-9 questionnaire over time will be reported. The PHQ-9 is self-administered, 9-item questionnaire measuring symptoms of depression. The recall period for all items is the past 2 weeks. The items include diminished interest or pleasure, depressed mood, insomnia/hypersomnia, fatigue or loss of energy, weight loss or weight gain/appetite loss or appetite gain, feelings of worthlessness, diminished concentration/indecisiveness, psychomotor agitation/retardation, and thoughts of death/suicide. Higher scores indicate more severe depressive symptoms.
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Timepoint [39]
0
0
Up to 3 years 9 months
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Secondary outcome [40]
0
0
Time to Deterioration in PGIS Questionnaire Over Time
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Assessment method [40]
0
0
Time to deterioration as per PGIS questionnaire over time will be reported. The PGIS is a self-administered, single item questionnaire measuring patients' impression of disease severity. Participants will be asked to rate their disease severity over the past 7 days using the following 5-point scale: 1 = None, 2 = Mild, 3 = Moderate, 4 = Severe, and 5 = Very severe. Higher scores indicate greater severity of fatigue.
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Timepoint [40]
0
0
Up to 3 years 9 months
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Secondary outcome [41]
0
0
Time to Deterioration as per PGIC Questionnaire Over Time
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Assessment method [41]
0
0
Time to Deterioration as per PGIC questionnaire over time will be reported. The PGIC is self-administered, single-item questionnaire measuring patients' impression of change in disease symptoms. Participants will be asked to rate their current symptoms as compared to when they started the study, using the following 7-point scale: 1 = Much better, 2 = Moderately better, 3 = A little better, 4 = No change, 5 = A little worse, 6 = Moderately worse, and 7 = Much worse. A higher PGIC score indicates greater worsening of symptoms.
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Timepoint [41]
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0
Up to 3 years 9 months
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Eligibility
Key inclusion criteria
* Diagnosis of prostate cancer prior to screening with histologically or cytologically confirmed adenocarcinoma of the prostate
* Metastatic prostate cancer disease documented by conventional imaging (example, computed tomography [CT], magnetic resonance imaging [MRI], or bone scan) and/or next-generation imaging [NGI] demonstrating greater than equal (>=) 2 distinct extraprostatic sites of metastasis
* Have an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1. Participants with ECOG PS 2 or 3 are eligible for the study if the ECOG PS score is related to stable physical limitations (example, wheelchair-bound due to prior spinal cord injury) and not related to prostate cancer or associated therapy
* A participant must agree not to plan to conceive a child while enrolled in this study or within 3 months after the last dose of study treatment
* Must be able to take whole apalutamide tablets by swallowing alone or with another vehicle (example, applesauce)
* Assigned male at birth, inclusive of all gender identities
* Participants who have undergone a bilateral orchidectomy and/or who are actively taking gender-affirming hormone therapy as part of their gender affirming care
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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
* History of seizure or known condition that has been determined to significantly predispose to seizure per investigator
* Pelvic lymph nodes as only site of metastasis
* Known allergies, hypersensitivity, or intolerance to excipients of apalutamide
* Any of the following within 6 months prior to screening: severe or unstable angina, myocardial infarction, symptomatic congestive heart failure, uncontrolled hypertension, clinically significant arterial or venous thromboembolic events
* 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
Open (masking not used)
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Who is / are masked / blinded?
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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
Recruiting
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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
31/08/2023
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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
7/01/2027
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Actual
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Sample size
Target
333
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Macquarie University Hospital - Macquarie University
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Recruitment hospital [2]
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Peter MacCallum Cancer Centre - Melbourne
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Recruitment hospital [3]
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Mater Misericordiae Hospital - South Brisbane
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Recruitment postcode(s) [1]
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2109 - Macquarie University
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Recruitment postcode(s) [2]
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3000 - Melbourne
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Recruitment postcode(s) [3]
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4101 - South Brisbane
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Recruitment outside Australia
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United States of America
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State/province [1]
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Alabama
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United States of America
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Arizona
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United States of America
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Arkansas
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California
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Colorado
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Florida
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Illinois
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Indiana
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Maryland
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Michigan
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New Jersey
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New York
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Ohio
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Oregon
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Pennsylvania
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Tennessee
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Texas
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Utah
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Virginia
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Brazil
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Barretos
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Brazil
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Belo Horizonte
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Brazil
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Natal
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Brazil
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Rio de Janeiro
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Brazil
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Salvador
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Brazil
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Santo André
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Brazil
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São Paulo
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Canada
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Alberta
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Canada
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Nova Scotia
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Canada
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Ontario
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Canada
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Quebec
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China
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Beijing
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China
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Changchun
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China
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Chengdu
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China
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Guangzhou
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China
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Jinan
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China
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Ningbo
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China
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Shenyang
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China
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Wuhan
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China
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XI An
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France
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Bordeaux
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France
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Lyon
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France
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Paris
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France
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Rennes
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France
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Villejuif Cedex
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Germany
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Aachen
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Germany
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Augsburg
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Germany
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Dresden
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Germany
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Koeln
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Germany
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Lubeck
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Germany
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Muenchen
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Germany
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Nuertingen
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Germany
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Würzburg
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Mexico
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State/province [53]
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Chihuahua
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Mexico
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Durango
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Mexico
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Merida
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Mexico
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State/province [56]
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Queretaro
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Country [57]
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Poland
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State/province [57]
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Bydgoszcz
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Country [58]
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Poland
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State/province [58]
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Koszalin
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Country [59]
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Poland
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State/province [59]
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Warszawa
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Country [60]
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Poland
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State/province [60]
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Wroclaw
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Janssen Research & Development, LLC
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of the study is to determine if the intermittent use of androgen-deprivation therapy (ADT) in participants with metastatic castrate-sensitive prostate cancer (mCSPC) who reached a prostate-specific antigen (PSA) level \< 0.2 nanograms/millilitres (ng/mL) after 6 months of treatment with apalutamide and ADT combination therapy provides non-inferior radiographic progression-free survival (rPFS) and a reduced burden of hot flashes measured as 18-month percent change in severity adjusted hot flash score.
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Trial website
https://clinicaltrials.gov/study/NCT05884398
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Janssen Research & Development, LLC Clinical Trial
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Address
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Janssen Research & Development, LLC
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Study Contact
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Address
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Country
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Phone
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844-434-4210
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
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When will data be available (start and end dates)?
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Available to whom?
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: https://www.janssen.com/clinical-trials/transparency
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT05884398