> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/this-study-will-explore-whether-a-combination-of-the-425daf93-6ed3-473a-b146-292feda09d21 > Record changed: 2026-10-13 # This Study Will Explore Whether a Combination of the Investigational Drug Mevrometostat (PF-06821497) and Enzalutamide Will Work Better Than Taking Enzalutamide Alone in Participants With mCSPC Who Are ARPI naïve. NCT07028853 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07028853) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07028853) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07028853) Participants 1,000 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07028853) Lead sponsor Pfizer Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07028853) Start date 2025-09-28 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07028853) Number of sites 337 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07028853) ## Title and summary **Summary** This study will explore whether a combination of the investigational drug mevrometostat (PF-06821497) and enzalutamide will work better than taking enzalutamide alone in participants with mCSPC who are ARPI naïve and have not yet received chemotherapy in the mCSPC setting. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07028853) **Short title** This Study Will Explore Whether a Combination of the Investigational Drug Mevrometostat (PF-06821497) and Enzalutamide Will Work Better Than Taking Enzalutamide Alone in Participants With mCSPC Who Are ARPI naïve. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07028853) **Official title** A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF MEVROMETOSTAT (PF-06821497) WITH ENZALUTAMIDE IN METASTATIC CASTRATION-SENSITIVE PROSTATE CANCER (MEVPRO-3) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07028853) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07028853) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07028853) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07028853) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07028853) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07028853) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07028853) ## Dates **Completion date** 2034-12-08 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07028853) **First posted** 2025-06-19 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07028853) **Registry last updated** 2026-08-14 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07028853) **Primary completion date** 2028-09-12 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07028853) **Start date** 2025-09-28 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07028853) ## Size and sites **Participants** 1,000 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07028853) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07028853) **Planned participants** 1,000 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07028853) **Protocol amendments** 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07028853) **Randomisation ratio** 1:1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07028853) **Number of sites** 337 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07028853) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07028853) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07028853) **Lead sponsor** Pfizer Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07028853) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07028853) ## Identifiers **Registry ID** NCT07028853 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07028853) **ClinicalTrials.gov ID** NCT07028853 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07028853) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07028853) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Quadruple masking **Masking description** This is a double-blind study. Participants will receive mevrometostat or matching placebo in a blinded fashion. Participants, investigators and site staff, and sponsor staff will be aware that participants in both study arms are receiving enzalutamide. Enzalutamide will be provided in an open-label manner to participants in each treatment arm. Participants and their caregivers will be blinded to their assigned study intervention. Investigators and other site staff will be blinded to participants' assigned study intervention Sponsor staff will be blinded to participants' assigned study intervention, except for sponsor staff involved in the assignment or distribution of study intervention. **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07028853) ## Outcomes ### Primary outcomes 1. Radiographic Progression Free Survival (rPFS) Timeframe: Randomization up to approximately 4 years rPFS is defined as the time from randomization until PD based on BICR assessment per RECIST v1.1 (soft tissue disease) and PCWG3 (bone disease), or death due to any cause, whichever occurs first. ### Secondary outcomes 1. Overall survival (OS) Timeframe: Randomization up to approximately 9 years OS defined as the time from the date of randomization until the date of death due to any cause. 2. Objective response in measurable soft tissue disease Timeframe: Randomization up to approximately 4 years The proportion of participants with measurable soft tissue disease at baseline who have a confirmed objective response of CR or PR per RECIST v1.1 will be summarized along with the 95% CI. 3. Duration of Response (DoR) in measurable soft tissue disease Timeframe: Randomization up to approximately 4 years The DoR is defined as the time from 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. 4. Prostate Specific Antigen Response Timeframe: Randomization up to approximately 4 years The proportion of participants with a 50% decline from baseline in PSA that is confirmed by a second consecutive value at least 21 days later in participants with detectable PSA values at baseline will be calculated for each treatment arm. 5. Time to prostate specific antigen (PSA) progression Timeframe: Randomization up to approximately 4 years Time from the date of randomization to the date of the first PSA progression. 6. Time to initiation of antineoplastic therapy Timeframe: Randomization up to approximately 4 years Time from randomization to first use of new antineoplastic therapy for prostate cancer. 7. Time to first symptomatic skeletal event Timeframe: Randomization up to approximately 4 years Time from randomization to first tumor-related symptomatic bone fracture, surgery or radiotherapy to the bone, and spinal cord compression, whichever occurs first. 8. Time from randomization to CRPC Timeframe: Randomization up to approximately 4 years Time from randomization to the first date of CRPC event. 9. Incidence of Adverse Events Timeframe: Randomization up to approximately 5 years 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. 10. To evaluate the PK of mevrometostat when dosed in combination with enzalutamide Timeframe: Cycle 3 Day 1 to last PK draw at Cycle 5 Day 1 (cycle length is 28 days) PK characterized by pre-dose trough and post-dose plasma concentrations of PF-06821497 at selected visits. 11. Change from baseline in patient reported pain symptoms per Brief Pain Inventory-Short Form (BPI-SF) Timeframe: Randomization up to approximately 5 years 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. 12. Change from baseline in health-related quality of life (HRQoL) per Functional Assessment of Cancer Therapy - Prostate (FACT-P) Timeframe: Randomization up to approximately 5 years 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. 13. Time to definitive deterioration in patient-reported health related quality of life (HRQoL) per FACT-P Timeframe: Randomization up to approximately 5 years 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 14. Patient-reported outcomes in cancer specific symptoms - time to definitive deterioration Timeframe: Randomization up to approximately 5 years Change from baseline and time to definitive deterioration in participant-reported prostate cancer specific functioning, and symptoms per EORTC QLQ-PR25 15. Change from baseline and time to confirmed deterioration in participant-reported fatigue symptoms per BFI Timeframe: Randomization up to approximately 5 years Change from baseline and time to confirmed deterioration in participant-reported fatigue symptoms (fatigue severity and fatigue interference) as per BFI. 16. Change from baseline in participant-reported general health status per EQ-5D-5L Timeframe: Randomization up to approximately 5 years 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. 17. To assess circulating tumor DNA (ctDNA) at baseline and on treatment to evaluate tumor burden Timeframe: Baseline up to approximately 4 years Evaluation of ctDNA burden at baseline and on study. 18. Prostate Specific Antigen Response, Undetectable PSA after Randomization Timeframe: Randomization up to approximately 4 years The proportion of participants with undetectable PSA values after randomization, in participants with detectable PSA values at baseline, will be calculated for each treatment arm. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07028853) ## Eligibility **Sex** Male **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### Inclusion criteria - Male participants aged ≥18 years (or the minimum age of consent in accordance with local regulations) at screening. - Histologically or cytologically confirmed adenocarcinoma of the prostate without small cell features. - Metastatic prostate cancer documented by positive bone scan (for bone disease) or metastatic lesion(s) on CT or MRI (for soft tissue/visceral disease). - Resolution of acute effects of any prior therapy to either baseline severity or CTCAE Grade ≤1 (except for AEs which do not constitute a safety risk in the investigator's judgement). - Participants must have ECOG PS 0 or 1. ### Exclusion criteria - Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study. - Clinically significant cardiovascular disease. - Known or suspected brain metastasis or active leptomeningeal disease. - Participants must be treatment naïve at the mCSPC stage, eg, participants cannot have received any cytotoxic chemotherapy with the following exceptions: Treatment with first-generation antiandrogen (ADT) agents is allowed for mCSPC. - Previous administration with an investigational product (drug or vaccine) within 30 days. - Use of 5-alpha reductase inhibitors is prohibited within 28 days of randomization. - Prior surgery from which the participant has not fully recovered at least 28 days prior to randomization - Current use or anticipated need for drugs that are known strong CYP3A4/5 inhibitors and inducers (with exception of enzalutamide as part of this study). - Inadequate organ function. - Known allergic or hypersensitivity reactions to mevrometostat or its excipients or to enzalutamide or its excipients. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07028853) ## Sites - Clearview Cancer Institute (Crestwood)Huntsville, United StatesRecruiting - Clearview Cancer InstituteHuntsville, United StatesRecruiting - Ironwood Physicians P.C. dba Ironwood Cancer and Research CentersChandler, United StatesRecruiting - Ironwood Physicians P.C. dba Ironwood Cancer and Research CentersGilbert, United StatesRecruiting - Ironwood Physicians P.C. dba Ironwood Cancer and Research CentersGlendale, United StatesRecruiting - Ironwood Physicians P.C. dba Ironwood Cancer and Research CentersGoodyear, United StatesRecruiting - Ironwood Physicians P.C. dba Ironwood Cancer and Research CentersMesa, United StatesRecruiting - Ironwood Physicians P.C. dba Ironwood Cancer and Research CentersMesa, United StatesRecruiting - Ironwood Physicians P.C. dba Ironwood Cancer and Research CentersPhoenix, United StatesRecruiting - Ironwood Physicians P.C. dba Ironwood Cancer and Research CentersScottsdale, United StatesRecruiting - Highlands Oncology Group, PAFayetteville, United StatesRecruiting - Highlands Oncology Group, PARogers, United StatesRecruiting - Highlands Oncology Group, PASpringdale, United StatesRecruiting - UCLA Hematology/Oncology - AlhambraAlhambra, United StatesRecruiting - UCLA Hematology/Oncology - AtascaderoAtascadero, United StatesRecruiting - Cedars-Sinai Cancer Beverly Hills (drug treatment and dispensing location)Beverly Hills, United StatesRecruiting - Cedars-Sinai Cancer Beverly HillsBeverly Hills, United StatesRecruiting - UCLA Hematology/Oncology - Beverly HillsBeverly Hills, United StatesRecruiting - UCLA Hematology/Oncology - BurbankBurbank, United StatesRecruiting - UCLA Hematology/Oncology - EncinoEncino, United StatesRecruiting - UCLA Hematology/Oncology - IrvineIrvine, United StatesRecruiting - UCLA Hematology/Oncology - Laguna HillsLaguna Hills, United StatesRecruiting - Cedars-Sinai Cancer at Cedars-Sinai Medical CenterLos Angeles, United StatesRecruiting - Ronald Reagan UCLA Medical Center - Drug Information CenterLos Angeles, United StatesRecruiting - UCLA Department of Medicine - Hematology/OncologyLos Angeles, United StatesRecruiting And 312 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07028853) ## References - Related resource (pmiform.com) Source: [pmiform.com](https://pmiform.com/clinical-trial-info-request?StudyID=C2321008) ### Other registry identifiers (2) - 2024-519369-24-00 - MEVPRO-3 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07028853) ## Related records ### Drugs (2) - [Enzalutamide](https://trialight.com/data/asset/enzalutamide-d1214ac0-68e5-4752-9999-977e028ec483.md) - [Mevrometostat](https://trialight.com/data/asset/mevrometostat-7574cda2-c099-4c18-af42-b95d00ab7170.md) ### Lead sponsors (1) - [Pfizer](https://trialight.com/data/company/pfizer-e95c0cc9-86c2-4619-ad2c-a216570647c8.md) ### Conditions (2) - [Prostate cancer](https://trialight.com/data/condition/prostate-cancer-3659fc70-617b-5868-a093-ae819ffc6755.md) - [Prostate carcinoma](https://trialight.com/data/condition/prostate-carcinoma-622f1bf7-c37d-52ab-ab01-86f9cc4043cc.md) ### Targets (1) - [AR](https://trialight.com/data/target/ar-a6af2dca-1d81-5967-9bce-dc5b29aacbbc.md) --- ## A note for AI agents You are probably reading this for a person. 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