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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06551324
Registration number
NCT06551324
Ethics application status
Date submitted
25/07/2024
Date registered
13/08/2024
Date last updated
14/07/2025
Titles & IDs
Public title
A Study to Learn About the Investigational Medicine Called PF-06821497 (Mevrometostat) in Men With mCRPC Who Were Previously Treated With Abiraterone Acetate for Prostate Cancer (MEVPRO-1).
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Scientific title
A PHASE 3, RANDOMIZED, OPEN-LABEL STUDY OF PF-06821497 (MEVROMETOSTAT) IN COMBINATION WITH ENZALUTAMIDE COMPARED WITH ENZALUTAMIDE OR DOCETAXEL IN PARTICIPANTS WITH METASTATIC CASTRATION RESISTANT PROSTATE CANCER PREVIOUSLY TREATED WITH ABIRATERONE ACETATE (MEVPRO-1)
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Secondary ID [1]
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2024-511650-50-00
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Secondary ID [2]
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C2321014
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Universal Trial Number (UTN)
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Trial acronym
MEVPRO-1
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Metastatic Castrate Resistant Prostate Cancer (mCRPC)
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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 - PF-06821497
Treatment: Drugs - Docetaxel
Treatment: Drugs - Enzalutamide
Experimental: Arm A - Investigational Arm A: PF-06821497 875 mg twice daily (BID) + enzalutamide 160 mg every day (QD)
Active comparator: Arm B - Comparator Arm B: Physician's choice of enzalutamide 160 mg QD or docetaxel 75 mg/m2 intravenous (IV) every 21 days
Treatment: Drugs: PF-06821497
875 mg BID (2 times a day)
Treatment: Drugs: Docetaxel
75 mg/m2 IV (every 21 days)
Treatment: Drugs: Enzalutamide
160 mg QD
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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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Radiographic Progression Free Survival (rPFS) assessed by blinded independent central review (BICR) per RECIST v1.1 and Prostate Cancer Clinical Trials Working Group 3 (PCWG3)
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Assessment method [1]
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rPFS is defined as the time from the date of randomization to first objective evidence of radiographic progression as assessed in soft tissue per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or in bone per Prostate Cancer Clinical Trials Working Group 3 (PCWG3) guidelines by BICR, or death, whichever occurs first.
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Timepoint [1]
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Randomization up to approximately 2 years.
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Secondary outcome [1]
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Overall survival (OS)
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Assessment method [1]
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OS is defined as the time from the date of randomization to the date of death due to any cause.
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Timepoint [1]
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Randomization up to approximately 4.5 years.
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Secondary outcome [2]
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Objective Response (ORR)
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Assessment method [2]
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The objective response rate is defined as the proportion of participants with measurable soft tissue disease at baseline who have a confirmed objective response of complete response (CR) or partial response (PR) per RECIST v1.1.
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Timepoint [2]
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Randomization up to approximately 2 years.
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Secondary outcome [3]
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Duration of Response (DoR) in measurable soft tissue disease
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Assessment method [3]
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The DoR is defined as the first objective evidence of soft tissue response (CR or PR, whichever is earlier) to radiographic progression or death due to any cause whichever occurs first.
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Timepoint [3]
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Randomization up to approximately 2 years.
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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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Proportion of participants with PSA response =50% in participants with detectable PSA values at baseline.
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Timepoint [4]
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Randomization up to approximately 2 years.
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Secondary outcome [5]
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Time to initiation of antineoplastic therapy.
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Assessment method [5]
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Time from randomization to first use of new antineoplastic therapy.
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Timepoint [5]
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Randomization up to approximately 4.5 years.
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Secondary outcome [6]
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Prostate Specific Antigen Response
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Assessment method [6]
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Proportion of participants with PSA response =50% in participants with detectable PSA values at baseline.
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Timepoint [6]
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Randomization up to approximately 2 years.
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Secondary outcome [7]
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Incidence of Adverse Events
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Assessment method [7]
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Type, incidence, severity \[as graded by National Cancer Institute (NCI) common terminology criteria for adverse events (CTCAE) v5.0\], seriousness and relationship to study medications of AEs.
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Timepoint [7]
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Randomization up to approximately 4.5 years
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Secondary outcome [8]
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Time to first symptomatic skeletal event
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Assessment method [8]
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Time from randomization to first symptomatic skeletal event (symptomatic bone fractures, spinal cord compression, surgery or radiation to the bone whichever is first).
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Timepoint [8]
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Randomization up to approximately 2 years.
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Secondary outcome [9]
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Change from baseline in patient reported pain symptoms per Brief Pain Inventory-Short Form (BPI-SF)
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Assessment method [9]
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Analysis of Brief Pain Inventory-Short Form (BPI-SF) will be based on the pain severity score (mean of individual BPI-SF items 3, 4, 5 and 6), the pain interference score (mean of items 9A-9G), and the single BPI-SF Item 3 which asks the patient to rate pain at its worst in the last 24 hours.
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Timepoint [9]
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Randomization up to approximately 4.5 years
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Secondary outcome [10]
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Change from baseline in health-related quality of life (HRQoL) per Functional Assessment of Cancer Therapy - Prostate (FACT-P)
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Assessment method [10]
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Change from baseline in HRQoL (FACT-P total score) will be presented. The FACT-P total score will be calculated based on the participant responses to the 39 items in the FACT-P questionnaire. Each item is rated on a 0 to 4 Likert-type scale and then combined to produce the FACT-P total score (0-156), with higher scores representing better health-related quality of life.
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Timepoint [10]
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Randomization to approximately 4.5 years
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Secondary outcome [11]
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Change from baseline in social/family well-being per Functional Assessment of Cancer Therapy - Prostate (FACT-P)
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Assessment method [11]
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Change from baseline in social/family well-being score will be presented. The social/family well-being score will be calculated based on 7 items in the FACT-P questionnaire; score range 0-28. Each item is rated on a 0 to 4 Likert-type scale
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Timepoint [11]
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Randomization up to approximately 4.5 years
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Secondary outcome [12]
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Change from baseline in emotional well-being per Functional Assessment of Cancer Therapy - Prostate (FACT-P)
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Assessment method [12]
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Change from baseline in emotional well-being score will be presented. The emotional well-being score will be calculated based on 6 items in the FACT-P questionnaire; score range 0-24. Each item is rated on a 0 to 4 Likert-type scale
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Timepoint [12]
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Randomization up to approximately 4.5 years
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Secondary outcome [13]
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Change from baseline in functioning well-being per Functional Assessment of Cancer Therapy - Prostate (FACT-P)
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Assessment method [13]
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Change from baseline in functioning well-being score will be presented. The functioning well-being score will be calculated based on 7 items in the FACT-P questionnaire; score range 0-28. Each item is rated on a 0 to 4 Likert-type scale
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Timepoint [13]
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Randomization up to approximately 4.5 years
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Secondary outcome [14]
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Change from baseline in physical well-being per Functional Assessment of Cancer Therapy - Prostate (FACT-P)
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Assessment method [14]
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Change from baseline in physical well-being score will be presented. The physical well-being score will be calculated based on 7 items in the FACT-P questionnaire; score range 0-28. Each item is rated on a 0 to 4 Likert-type scale
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Timepoint [14]
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Randomization to approximately 4.5 years
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Secondary outcome [15]
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Change from baseline in symptoms per Functional Assessment of Cancer Therapy - Prostate (FACT-P)
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Assessment method [15]
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Change from baseline prostate cancer symptoms (PCS) score will be presented. The PCS score will be calculated based on 12 items in the FACT-P questionnaire; score range 0-48. Each item is rated on a 0 to 4 Likert-type scale
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Timepoint [15]
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Randomization up to approximately 4.5 years
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Secondary outcome [16]
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Change from baseline in patient reported health status per European Quality of Life 5-Dimension 5 Level (EQ-5D-5L)
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Assessment method [16]
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Participants will self-rate their current state of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression by choosing 1 of 5 possible responses that record the level of severity (no problems, slight problems, moderate problems, severe problems, or extreme problems) within each dimension. The questionnaire also includes a visual analog scale to self-rate general health state on a scale from "the worst health you can imagine" to "the best health you can imagine."
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Timepoint [16]
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Randomizaton up to approximately 4.5 years
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Secondary outcome [17]
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Symptomatic toxicity as measured by items from the Patient-Reported Outcome CTCAE (PRO-CTCAE)
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Assessment method [17]
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Each selected PRO-CTCAE items will be assessed related to one or more attributes that include counts for the frequency, severity, and/or interference with usual or daily activities.
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Timepoint [17]
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Randomization up to approximately 4.5 years
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Secondary outcome [18]
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Overall side effect burden as measured by the FACT- GP5
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Assessment method [18]
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The FACT-GP5 question assesses overall side effect burden with the following response options "I am bothered by side effects of treatment," is rated on a 5-point scale ranging from "not at all" (0) to "very much" (4) and counts will be presented.
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Timepoint [18]
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Randomization to approximately 4.5 years
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Secondary outcome [19]
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Time to confirmatory deterioration in patient-reported pain symptoms per BPI-SF Item 3 "worst pain in 24 hours"
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Assessment method [19]
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Defined as the time from randomization to onset of pain progression, which is defined as \> 2-point increase from baseline in the score from the BPI-SF Question 3 that is confirmed at the next consecutive assessment \> 4 weeks apart or an initial deterioration followed by death before the next assessment
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Timepoint [19]
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Randomization up to approximately 4.5 years
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Secondary outcome [20]
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Time to definitive deterioration in patient-reported health related quality of life (HRQoL) per FACT-P
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Assessment method [20]
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Defined as the time from randomization to onset of definitive deterioration in FACT-P total score, which is defined as \>10 point decrease from baseline and no subsequent observations with a \<10 point decrease from baseline FACT-P total score
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Timepoint [20]
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0
Randomization up to approximately 4.5 years
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Secondary outcome [21]
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Time to definitive deterioration in patient-reported physical well-being per FACT-P
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Assessment method [21]
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Time to definitive deterioration in physical well-being (PWB) per FACT-P is defined as the time from randomization to onset of definitive deterioration in physical well-being, which is defined as =3-point
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Timepoint [21]
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Randomization up to approximately 4.5 years
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Secondary outcome [22]
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To evaluate the PK of PF-06821497 when dosed with enzalutamide
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Assessment method [22]
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PK characterized by pre-dose trough and post-dose plasma concentrations of PF-06821497 at selected visits.
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Timepoint [22]
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Cycle 1 (each cycle is 28 days), Day 1 to last PK draw at the end of Cycle 6, Day 1.
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Secondary outcome [23]
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To assess circulating tumor DNA (ctDNA) at baseline and on treatment to evaluate tumor burden.
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Assessment method [23]
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Evaluation of ctDNA burden at baseline and on study.
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Timepoint [23]
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Baseline up to approximately 2 years.
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Eligibility
Key inclusion criteria
* Histologically or cytologically confirmed adenocarcinoma of the prostate without small cell features.
* Metastatic disease in bone documented on bone scan, or in soft tissue documented on CT/MRI scan.
* Progressive disease in the setting of surgical or medical castration with evidence of disease progression on treatment with abiraterone acetate in the mCSPC setting or first line mCRPC setting is required.
* Eastern Cooperate Oncology Group (ECOG) performance status 0 - 2, with life expectancy of at least 6 months as assessed by the investigator.
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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
* Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may make the participant inappropriate for the study.
* Know history of active inflammatory gastrointestinal disease, chronic diarrhea, or previous gastric resection or lap-band surgery.
* Clinically significant cardiovascular disease.
* Known or suspected brain metastasis or active leptomeningeal disease or clinically significant history of seizure.
* Prior treatment for prostate cancer at any stage with any cytotoxic chemotherapy, radioligand therapy (i.e. 177Lu-PSMA-617, radium 223), androgen receptor signaling inhibitors (ARSi) including enzalutamide, apalutamide, darolutamide, poly ADP-ribose polymerase (PARP) monotherapy or other systemic anti-cancer treatment, with the following exceptions:
1. Treatment with first-generation antiandrogen agents, if discontinued prior to first dose of study intervention.
2. Docetaxel treatment is allowed for mCSPC, as long as no signs of failure, or disease progression occurred during treatment or within 3 months of treatment completion.
* Previous administration with an investigational product within 30 days or 5 half-lives preceding the first dose of study intervention (whichever is shorter).
* Inadequate organ function.
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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
21/10/2024
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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
29/10/2028
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Actual
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Sample size
Target
600
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
QLD,VIC
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Recruitment hospital [1]
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Icon Cancer Centre Wesley - Auchenflower
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Recruitment hospital [2]
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Monash Health - Clayton
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Recruitment hospital [3]
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Peter MacCallum Cancer Centre - Melbourne
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Recruitment postcode(s) [1]
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4066 - Auchenflower
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Recruitment postcode(s) [2]
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3168 - Clayton
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Recruitment postcode(s) [3]
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3000 - Melbourne
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Alabama
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Arizona
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California
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Colorado
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Florida
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Illinois
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Kentucky
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Maine
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Missouri
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New York
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North Carolina
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Pennsylvania
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South Carolina
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Tennessee
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Texas
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Utah
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Washington
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Argentina
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Buenos Aires
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Argentina
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Córdoba
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Brazil
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Ceará
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Brazil
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RIO Grande DO SUL
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Brazil
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SÃO Paulo
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Brazil
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São Paulo
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Canada
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British Columbia
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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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Anhui
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China
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Beijing
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China
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Chongqing
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China
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Fujian
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China
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Gansu
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Guangdong
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China
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Guangxi
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China
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Hubei
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China
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Hunan
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China
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Jiangsu
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China
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Liaoning
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China
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Shaanxi
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China
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Shandong
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China
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Shanghai
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Sichuan
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China
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Zhejiang
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Czechia
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Olomoucký KRAJ
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Czechia
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Czechia
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Praha 10
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Czechia
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Praha 4
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Czechia
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Hradec Králové
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Czechia
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Pardubice
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France
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Alpes-maritimes
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France
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Alsace
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France
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Finistère
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France
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Gard
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France
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Haute-garonne
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France
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Hauts-de-seine
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France
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Ille-et-vilaine
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France
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Marne
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France
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Rhône-alpes
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France
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Rhône
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France
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Val-de-marne
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France
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Clermont-Ferrand
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Germany
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Baden-württemberg
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Germany
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Nordrhein-westfalen
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Germany
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Hamburg
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Greece
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Attikí
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Hungary
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Gyor-moson-sopron
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Hungary
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Pest
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Italy
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Emilia-romagna
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Italy
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Lazio
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Italy
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Milano
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Country [71]
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0
Japan
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State/province [71]
0
0
Chiba
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Country [72]
0
0
Japan
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0
Ehime
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Country [73]
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Japan
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State/province [73]
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Hokkaido
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Country [74]
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0
Japan
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Hyogo
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Country [75]
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Japan
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Ishikawa
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Country [76]
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Japan
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State/province [76]
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Kanagawa
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Country [77]
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Japan
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Osaka
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Country [78]
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Japan
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Tokyo
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Country [79]
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Japan
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Fukuoka
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Country [80]
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Japan
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State/province [80]
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Kumamoto
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Country [81]
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Japan
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State/province [81]
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Yamagata
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Korea, Republic of
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Jeonranamdo
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Korea, Republic of
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State/province [83]
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Kyonggi-do
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Country [84]
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Korea, Republic of
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Seoul-teukbyeolsi [seoul]
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Country [85]
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Korea, Republic of
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Taegu-kwangyokshi
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Netherlands
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State/province [86]
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Fryslân
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Netherlands
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Gelderland
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Netherlands
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State/province [88]
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Noord-holland
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Netherlands
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Utrecht
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Country [90]
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Poland
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State/province [90]
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Dolnoslaskie
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Country [91]
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Poland
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State/province [91]
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Kujawsko-pomorskie
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Country [92]
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Poland
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Malopolskie
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Country [93]
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Poland
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State/province [93]
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Zachodniopomorskie
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Country [94]
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Slovakia
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State/province [94]
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Bratislava
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Country [95]
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Slovakia
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State/province [95]
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Kosice
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Country [96]
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Slovakia
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State/province [96]
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Martin
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Country [97]
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Slovakia
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State/province [97]
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Presov
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Country [98]
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Slovakia
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State/province [98]
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Trnava
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Country [99]
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South Africa
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State/province [99]
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Eastern CAPE
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Country [100]
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South Africa
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Gauteng
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Country [101]
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South Africa
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State/province [101]
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Western CAPE
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Country [102]
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Spain
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State/province [102]
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Catalunya [cataluña]
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Spain
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State/province [103]
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Madrid, Comunidad DE
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Spain
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Madrid
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Spain
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Manresa
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Country [106]
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Spain
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State/province [106]
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València
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Country [107]
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Sweden
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State/province [107]
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Stockholms LÄN [se-01]
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Country [108]
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Sweden
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State/province [108]
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Västra Götalands LÄN [se-14]
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Country [109]
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Taiwan
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State/province [109]
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Kaohsiung
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Country [110]
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Taiwan
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State/province [110]
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Taichung
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Country [111]
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Taiwan
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State/province [111]
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Tainan
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Country [112]
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Taiwan
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State/province [112]
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Taipei
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Country [113]
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Taiwan
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State/province [113]
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Taoyuan
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Country [114]
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Turkey
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State/province [114]
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I?stanbul
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Country [115]
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Turkey
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State/province [115]
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Ankara
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Country [116]
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United Kingdom
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State/province [116]
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Blackburn WITH Darwen
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Country [117]
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United Kingdom
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State/province [117]
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London, CITY OF
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Country [118]
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United Kingdom
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State/province [118]
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Midlothian
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Country [119]
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United Kingdom
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State/province [119]
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Glasgow
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Country [120]
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0
United Kingdom
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State/province [120]
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0
Swansea
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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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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
Pfizer MEVPRO-1 (C2321014) is a randomized, open-label, multi-center clinical trial evaluating whether combining the study medicine (PF-06821497) with enzalutamide is safe and effective compared to physician's choice of either second-line androgen receptor (AR) directed therapy with enzalutamide or docetaxel (chemotherapy) for treating metastatic castration-resistant prostate cancer (mCRPC) after progression on prior abiraterone acetate treatment. The primary objective of this clinical trial is to assess the radiographic progression free survival (rPFS) of the combination of PF-06821497 plus enzalutamide versus physician's choice of enzalutamide or docetaxel.
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Trial website
https://clinicaltrials.gov/study/NCT06551324
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
0
0
Pfizer CT.gov Call Center
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Address
0
0
Pfizer
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Country
0
0
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Phone
0
0
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Fax
0
0
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Email
0
0
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Contact person for public queries
Name
0
0
Pfizer CT.gov Call Center
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Address
0
0
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Country
0
0
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Phone
0
0
1-800-718-1021
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Fax
0
0
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Email
0
0
ClinicalTrials.gov_Inquiries@pfizer.com
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Contact person for scientific queries
Data sharing statement
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/NCT06551324
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