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Purpose

This study will explore whether a combination of the investigational drug PF-06821497 and enzalutamide will work better than taking enzalutamide alone in participants with mCRPC who are ARSi or abiraterone naïve.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
Male
Accepts Healthy Volunteers
No

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 medical or surgical castration. - ECOG performance status 0 or 1, with a life expectancy of ≥12 months as assessed by the investigator.

Exclusion Criteria

  • Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that make the participant inappropriate for the study. - Known 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. - Any history of myelodysplastic syndrome, acute myeloid leukemia, or any other prior malignancy with a few exceptions. - Participants must be treatment naïve at the mCRPC stage, eg, no cytotoxic chemotherapy, radio-ligand therapy (i.e. 177Lu- PSMA-617), CDK4/6 inhibitors, 5-alpha reductase inhibitors for prostate cancer in any setting, 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 (ADT) agents; 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 (drug or vaccine) within 30 days or 5 half-lives preceding the first dose of study intervention (whichever is longer). - Inadequate organ function.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
This is a double-blind study. Participants will receive PF-06821497 or matching placebo in a blinded fashion, as indicated in Section 6.1. 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.

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Arm A 		Participants will receive PF-06821497 (875 mg) BID (twice daily) + enzalutamide 160 mg QD (once daily)
  • Drug: PF-06821497
    Oral continuous
    Other names:
    • Mevrometostat
  • Drug: Enzalutamide
    Oral continuous
    Other names:
    • Xtandi
Active Comparator
Arm B 		Participants will receive Placebo BID (twice daily) + enzalutamide 160 mg QD (once daily)
  • Drug: Placebo
    Oral continuous
  • Drug: Enzalutamide
    Oral continuous
    Other names:
    • Xtandi

Recruiting Locations

Ironwood Cancer & Research Centers
Chandler 5289282, Arizona 5551752 85224

Ironwood Cancer & Research Centers
Gilbert 5295903, Arizona 5551752 85297

Palo Verde Hematology Oncology
Glendale 5295985, Arizona 5551752 85304

Ironwood Cancer & Research Centers
Glendale 5295985, Arizona 5551752 85306

Ironwood Cancer & Research Centers
Goodyear 5296266, Arizona 5551752 85395

Ironwood Cancer & Research Centers
Mesa 5304391, Arizona 5551752 85202

Ironwood Cancer & Research Centers
Mesa 5304391, Arizona 5551752 85206

Ironwood Cancer & Research Centers
Phoenix 5308655, Arizona 5551752 85028

Ironwood Cancer & Research Centers
Scottsdale 5313457, Arizona 5551752 85260

Highlands Oncology
Fayetteville 4110486, Arkansas 4099753 72703

Arkansas Urology - Little Rock
Little Rock 4119403, Arkansas 4099753 72211

Highlands Oncology
Rogers 4128894, Arkansas 4099753 72758

Highlands Oncology Group
Springdale 4132093, Arkansas 4099753 72762

Los Angeles Cancer Network (LACN)
Anaheim 5323810, California 5332921 92801

Los Angeles Cancer Network (LACN)
Fountain Valley 5350207, California 5332921 92708

Los Angeles Cancer Network (LACN)
Glendale 5352423, California 5332921 91204

Los Angeles Cancer Network (LACN)
Glendale 5352423, California 5332921 91206

Los Angeles Cancer Network (LACN)
Los Angeles 5368361, California 5332921 90017

Los Angeles Cancer Network (LACN)
Los Angeles 5368361, California 5332921 90067

Medical Oncology Associates of San Diego
San Diego 5391811, California 5332921 92123

Accellacare of Duly
Lisle 4900080, Illinois 4896861 60532

Duly Health and Care (Bone Scintigraphy)
Lisle 4900080, Illinois 4896861 60532

Blessing Hospital
Quincy 4247703, Illinois 4896861 62301

Blessing Physician Services
Quincy 4247703, Illinois 4896861 62301

Duly Health and Care (CT and MRI)
Westmont 4916207, Illinois 4896861 60559

Adult & Pediatric Urology, PC
Omaha 5074472, Nebraska 5073708 68114

CHRISTUS St. Vincent Regional Cancer Center
Santa Fe 5490263, New Mexico 5481136 87505

Montefiore Medical Center - Medical Park
The Bronx 5110266, New York 5128638 10461

Montefiore Medical Center
The Bronx 5110266, New York 5128638 10467

Salisbury VA Medical Center
Salisbury 4489985, North Carolina 4482348 28144

AUC Urologists, LLC
Myrtle Beach 4588718, South Carolina 4597040 29572

Carolina Urologic Research Center, LLC
Myrtle Beach 4588718, South Carolina 4597040 29572

Grand Strand Medical Center
Myrtle Beach 4588718, South Carolina 4597040 29572

Parkway Surgery Center
Myrtle Beach 4588718, South Carolina 4597040 29572

USA Clinical Trials
San Antonio 4726206, Texas 4736286 78229

Northwest Medical Specialties, PLLC
Bonney Lake 5787776, Washington 5815135 98391

Northwest Medical Specialties, PLLC
Federal Way 5794245, Washington 5815135 98003

Northwest Medical Specialties, PLLC
Gig Harbor 5795440, Washington 5815135 98332

Northwest Medical Specialties, PLLC
Puyallup 5807575, Washington 5815135 98373

Harborview Medical Center
Seattle 5809844, Washington 5815135 98104

Fred Hutchinson Cancer Center
Seattle 5809844, Washington 5815135 98109

University of Washington Medical Center - Montlake
Seattle 5809844, Washington 5815135 98195

Northwest Medical Specialties, PLLC
Tacoma 5812944, Washington 5815135 98405

More Details

NCT ID
NCT06629779
Status
Recruiting
Sponsor
Pfizer

Study Contact

Pfizer CT.gov Call Center
1-800-718-1021
ClinicalTrials.gov_Inquiries@pfizer.com

Detailed Description

This is a global, multicenter, randomized Phase 3 study evaluating PF-06821497 (mevrometostat) in combination with enzalutamide versus placebo in combination with enzalutamide in participants with mCRPC where no systemic anti-cancer treatments have been initiated after documentation of mCRPC with the exception of ADT (androgen deprivation therapy) and first-generation anti-androgen agents. Prior treatment with any of the ARSi's enzalutamide, darolutamide, apalutamide, or abiraterone acetate, is not permitted in any setting. Chemotherapy is permitted in the castrate sensitive setting. This study consists of a Screening Phase, Randomization, Treatment Phase, Safety Follow-up, and Long-Term Follow-up. Participants will be randomized on a 1:1 basis to receive (Arm A) PF-06821497 in combination with enzalutamide, or (Arm B) placebo in combination with enzalutamide.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.

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