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.

Part of paid clinical trials in Huntsville, Alabama.

Sponsor
Pfizer
Study ID
NCT07028853
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • Cancer of the Prostate
  • Hormone Sensitive Prostate Cancer
  • Metastatic Castration Sensitive Prostate Cancer (mCSPC)
  • Prostate Cancer

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Mevrometostat — DRUG
    Oral continuous
  • Placebo — DRUG
    Oral continuous
  • Enzalutamide — DRUG
    Oral continuous

Study Details

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.

Key Dates

Start date
Sep 28, 2025
Status verified
Jun 2026
Primary completion
Sep 12, 2028
Completion
Dec 8, 2034

Study Design

Enrollment
1,000 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A
    Participants will receive mevrometostat/PF-06821497 (875 mg) BID (twice daily) + enzalutamide 160 mg QD (once daily)
  • Active Comparator: Arm B
    Participants will receive Placebo BID (twice daily) + enzalutamide 160 mg QD (once daily)

Primary Outcome Measure

Radiographic Progression Free Survival (rPFS) [ Time Frame: Randomization up to approximately 4 years ]

Central Contacts

Locations (120)

FacilityCityStateZIPSite coordinators
Clearview Cancer InstituteHuntsvilleAlabama35805-
Clearview Cancer Institute (Crestwood)HuntsvilleAlabama35801-
Ironwood Cancer & Research CentersChandlerArizona85224-
Ironwood Physicians P.C. dba Ironwood Cancer and Research CentersChandlerArizona85224-
Ironwood Cancer & Research CentersGilbertArizona85297-
Ironwood Cancer & Research CentersGlendaleArizona85306-
Ironwood Cancer & Research CentersGoodyearArizona85395-
Ironwood Cancer & Research CentersMesaArizona85202-
Ironwood Cancer & Research CentersMesaArizona85206-
Ironwood Cancer & Research CentersPhoenixArizona85028-
Ironwood Cancer & Research CentersScottsdaleArizona85260-
Highlands Oncology Group, PAFayettevilleArkansas72703-
Highlands Oncology Group, PARogersArkansas72758-
Highlands Oncology Group, PASpringdaleArkansas72762-
UCLA Hematology/Oncology - AlhambraAlhambraCalifornia91801-
UCLA Hematology/Oncology - AtascaderoAtascaderoCalifornia93422-
Cedars-Sinai Cancer Beverly HillsBeverly HillsCalifornia90211-
Cedars-Sinai Cancer Beverly Hills (drug treatment and dispensing location)Beverly HillsCalifornia90211-
UCLA Hematology/Oncology - Beverly HillsBeverly HillsCalifornia90212-
UCLA Hematology/Oncology - BurbankBurbankCalifornia91505-
UCLA Hematology/Oncology - EncinoEncinoCalifornia91436-
UCLA Hematology/Oncology - IrvineIrvineCalifornia92604-
UCLA Hematology/Oncology - Laguna HillsLaguna HillsCalifornia92653-
Cedars-Sinai Cancer at Cedars-Sinai Medical CenterLos AngelesCalifornia90048-
Ronald Reagan UCLA Medical Center - Drug Information CenterLos AngelesCalifornia90095-
UCLA Department of Medicine - Hematology/OncologyLos AngelesCalifornia90095-
UCLA Hematology/OncologyLos AngelesCalifornia90095-
UCLA Hematology/Oncology - Marina del ReyMarina del ReyCalifornia90292-
UCLA Hematology/Oncology - PasadenaPasadenaCalifornia91105-
UCLA Hematology/Oncology - Porter RanchPorter RanchCalifornia91326-
UCLA Hematology/Oncology - San Luis ObispoSan Luis ObispoCalifornia93401-
UCLA Hematology/Oncology - Santa BarbaraSanta BarbaraCalifornia93101-
UCLA Hematology/Oncology- Santa MonicaSanta MonicaCalifornia90404-
UCLA Hematology/Oncology - TorranceTorranceCalifornia90505-
UCLA Hematology/Oncology - Santa ClaritaValenciaCalifornia91355-
UCLA Hematology/Oncology - VenturaVenturaCalifornia93003-
UCLA Hematology/Oncology - WestlakeWestlake VillageCalifornia91361-
AdventHealth Medical Group Urology of DenverDenverColorado80210-
Tennessee Oncology, PLLC - DaltonDaltonGeorgia30720-
Tennessee Oncology, PLLC - RinggoldRinggoldGeorgia30736-
Associated Urological Specialists - Chicago RidgeChicago RidgeIllinois60415-
Cancer Care Specialists of IllinoisDecaturIllinois62526-
Cancer Care Specialists of IllinoisO'FallonIllinois62269-
Michigan Institute of Urology, PCTroyMichigan48084-
MSK Basking RidgeBasking RidgeNew Jersey07920-
MSK MonmouthMiddletownNew Jersey07748-
MSK BergenMontvaleNew Jersey07645-
MSK CommackCommackNew York11725-
MSKCC-Westchester (500 Westchester Ave.)HarrisonNew York10604-
Memorial Sloan Kettering Cancer Center (IDS Pharmacy)Long Island CityNew York11101-
Evelyn H. Lauder Breast and Imaging Center (BAIC).New YorkNew York10065-
Memorial Sloan Kettering Cancer Center - Main CampusNew YorkNew York10065-
Sidney Kimmel Center for Prostate and Urological Cancers - Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
University of Rochester Medical CenterRochesterNew York14642-
University of Rochester, Cancer Center Pharmacy (Investigational Product)RochesterNew York14642-
Montefiore Einstein Comprehensive Cancer CenterThe BronxNew York10461-
Montefiore Medical Center- Montefiore Medical ParkThe BronxNew York10461-
MSK Nassau.UniondaleNew York11553-
Duke Cancer Center CaryCaryNorth Carolina27518-
Duke UniversityDurhamNorth Carolina27713-
Duke University Medical Center - Duke Cancer CenterDurhamNorth Carolina27710-
Duke University Medical Center - Duke University Hospital (location of scans)DurhamNorth Carolina27710-
Duke University Medical Center (location of scans)DurhamNorth Carolina27710-
Duke Cancer Center RaleighRaleighNorth Carolina27609-
Duke Raleigh HospitalRaleighNorth Carolina27609-
Duke Women's Cancer Care Raleigh (Pharmacy location and location of CT, MRI and Bone scan machines)RaleighNorth Carolina27609-
University Hospitals Seidman Cancer Center at UH Avon Health CenterAvonOhio44011-
TriState Urologic Services PSC Inc. dba The Urology GroupCincinnatiOhio45212-
University Hospitals Cleveland Medical CenterClevelandOhio44106-
University Hospitals Seidman Cancer Center at UH Mentor Health CenterMentorOhio44060-
UH Minoff Health Center at Chagrin HighlandsOrangeOhio44122-
MidLantic urologyBala-CynwydPennsylvania19004-
The Centers for Advanced Urology, LLP d/b/a Keystone Urology SpecialistsLancasterPennsylvania17604-
Carolina Urologic Research Center, LLCMyrtle BeachSouth Carolina29572-
Grand Strand Medical CenterMyrtle BeachSouth Carolina295724607-
Parkway Surgery CenterMyrtle BeachSouth Carolina29572-
Tennessee Oncology PLLCChattanoogaTennessee37404-
Tennessee Oncology, PLLC - Chattanooga DowntownChattanoogaTennessee37403-
Tennessee Oncology, PLLC - Chattanooga EastChattanoogaTennessee37421-
Tennessee Oncology, PLLC - Chattanooga Med Park IIChattanoogaTennessee37404-
Tennessee Oncology, PLLC - Chattanooga MemorialChattanoogaTennessee37404-
Tennessee Oncology, PLLC - ClevelandClevelandTennessee37311-
Tennessee Oncology, PLLC - CookevilleCookevilleTennessee38501-
Tennessee Oncology, PLLC - DicksonDicksonTennessee37055-
Tennessee Oncology, PLLC - FranklinFranklinTennessee37067-
Tennessee Oncology, PLLC - GallatinGallatinTennessee37066-
The West Clinic, PLLC dba West Cancer CenterGermantownTennessee38138-
Tennessee Oncology HendersonvilleHendersonvilleTennessee37075-
Tennessee Oncology, PLLC - LebanonLebanonTennessee37090-
Tennessee Oncology, PLLC - Mount JulietMount JulietTennessee37122-
Tennessee Oncology, PLLC - MurfreesboroMurfreesboroTennessee37129-
Tennessee Oncology, PLLC - Investigational Drug ServicesNashvilleTennessee37203-
Tennessee Oncology, PLLC - Nashville Elliston Place Plaza Medical Oncology & HematologyNashvilleTennessee37203-
Tennessee Oncology, PLLC - Nashville Saint Thomas WestNashvilleTennessee37205-
Tennessee Oncology, PLLC - Nashville SkylineNashvilleTennessee37207-
Tennessee Oncology, PLLC - Nashville Southern HillsNashvilleTennessee37211-
Urology Associates, P.C.NashvilleTennessee37209-
Tennessee Oncology, PLLC - ShelbyvilleShelbyvilleTennessee37160-
Tennessee Oncology, PLLC - SmyrnaSmyrnaTennessee37167-
University of Texas Southwestern Medical CenterDallasTexas75390-
University of Texas Southwestern Medical Center - Simmons Cancer CenterDallasTexas75235-
University of Texas Southwestern Medical Center - William P. Clements, Jr., University HospitalDallasTexas75235-
University of Texas Southwestern Medical Center-Zale Lipshy University HospitalDallasTexas75390-
University of Texas Southwestern Simmons Cancer Center - RedbirdDallasTexas75237-
University of Texas Southwestern Simmons Cancer Center - Fort WorthFort WorthTexas76104-
US Oncology Investigational Product Center (IPC)IrvingTexas75063-
University of Texas Southwestern Simmons Cancer Center - Richardson/PlanoRichardsonTexas75080-
Huntsman Cancer InstituteSalt Lake CityUtah84112-
Blue Ridge Cancer CareBlacksburgVirginia24060-
Blue Ridge Cancer CareLow MoorVirginia24457-
Blue Ridge Cancer CareRoanokeVirginia24014-
Blue Ridge Cancer CareSalemVirginia24153-
Blue Ridge Cancer CareWythevilleVirginia24382-
Northwest Medical Specialties, PLLCBonney LakeWashington98391-
Northwest Medical Specialties, PLLCFederal WayWashington98003-
Northwest Medical Specialties, PLLCGig HarborWashington98332-
Northwest Medical Specialties, PLLCPuyallupWashington98373-
Northwest Medical Specialties, PLLCTacomaWashington98405-
University of Wisconsin Carbone Cancer Center - Eastpark Medical CenterMadisonWisconsin53718-
University of Wisconsin Carbone Cancer Center - University HospitalMadisonWisconsin53792-

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Clearview Cancer Institute· Huntsville, ALClearview Cancer Institute (Crestwood)· Huntsville, ALIronwood Cancer & Research Centers· Chandler, AZIronwood Physicians P.C. dba Ironwood Cancer and Research Centers· Chandler, AZIronwood Cancer & Research Centers· Gilbert, AZIronwood Cancer & Research Centers· Glendale, AZ

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