Comparing Mevrometostat with Enzalutamide for metastatic castration sensitive prostate cancer (mcspc)
Official 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.
A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF MEVROMETOSTAT (PF-06821497) WITH ENZALUTAMIDE IN METASTATIC CASTRATION-SENSITIVE PROSTATE CANCER (MEVPRO-3)
Interventions
Mevrometostat
Oral continuous
Placebo
Oral continuous
Enzalutamide
Oral continuous
Canadian Sites (10)
Prostate Cancer Centre
Calgary, Alberta, Canada
Centre of Applied Urology Research/Nova Scotia Health Authority
Halifax, Nova Scotia, Canada
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, Canada
Lakeridge Health
Oshawa, Ontario, Canada
Centre Intégré de Santé et de Services Sociaux de la Montérégie-Centre
Greenfield Park, Quebec, Canada
Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, Canada
Jewish General Hospital
Montreal, Quebec, Canada
Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus
Québec, Quebec, Canada
Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Univer
Sherbrooke, Quebec, Canada
Diex Recherche Trois-Rivieres
Trois-Rivières, Quebec, Canada
Eligibility Criteria
See who this study is looking for26 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Known allergic or hypersensitivity reactions to mevrometostat or its excipients or to enzalutamide or its excipients.
- +Known or suspected brain metastasis or active leptomeningeal disease.
- +Male participants aged ≥18 years (or the minimum age of consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more → in accordance with local regulations) at screeningScreeningThe checks done before joining, to see whether a study fits.Read more →.
- +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 baselineBaselineYour starting measurements, taken before treatment begins.Read more → severity or CTCAE Grade ≤1 (except for AEs which do not constitute a safety risk in the investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →'s judgement).
- +Participants must have ECOG PS 0 or 1.
- +Exclusion CriteriaExclusion criteriaThe things that would prevent someone from taking part.Read more →
- +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.
- +Previous administration with an investigational product (drug or vaccine) within 30 days.
- +Use of 5-alpha reductase inhibitors is prohibited within 28 days of randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more →.
- +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.
- +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.
- +Prior surgery from which the participant has not fully recovered at least 28 days prior to randomization
Exclusion
- −Known allergic or hypersensitivity reactions to mevrometostat or its excipients or to enzalutamide or its excipients.
- −Known or suspected brain metastasis or active leptomeningeal disease.
- −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 investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →'s judgment, make the participant inappropriate for the study.
- −Clinically significant cardiovascular disease.
- −Previous administration with an investigational product (drug or vaccine) within 30 days.
- −Use of 5-alpha reductase inhibitors is prohibited within 28 days of randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more →.
- −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.
- −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.
- −Prior surgery from which the participant has not fully recovered at least 28 days prior to randomization
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 3Phase 3A large study comparing a treatment against the current standard.Read more → — a large study comparing this against the current standard, usually across many hospitals.
What is being given or done in this study: Mevrometostat, PlaceboPlaceboA dummy treatment with no active medicine, used for comparison.Read more →, Enzalutamide.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
- armsInterventionsModule.interventions[].name
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
You, the study team, the people giving the treatment, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment, so the two can be compared.
There are 2 groups in this study.
From the trial registry
Built from this field:
- armsInterventionsModule.armGroups[].type
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study lists male participants only.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 1,000 people.
The study is currently expected to finish around December 2034.
The main measurement is taken over: RandomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more → up to approximately 4 years.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Radiographic Progression Free Survival (rPFS) — measured over RandomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more → up to approximately 4 years.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT07028853 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About MevrometostatDrug
Oral continuous
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About PlaceboDrug
Oral continuous
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About EnzalutamideDrug
Oral continuous
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment so the two can be compared.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
You, the study team, the people giving the treatment, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It lists male participants only.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: RandomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more → up to approximately 4 years.
The study as a whole is currently expected to finish around 2034-12-08.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 1,000 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 23 locations, including: Calgary, Alberta, Canada; Halifax, Nova Scotia, Canada; Hamilton, Ontario, Canada; Oshawa, Ontario, Canada; Greenfield Park, Quebec, Canada; Montreal, Quebec, Canada, and 17 more.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
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.
Other Sites (18)
Michigan Institute of Urology, PC
Troy, Michigan, United States
MSK Commack
Commack, New York, United States
MSKCC-Westchester (500 Westchester Ave.)
Harrison, New York, United States
Memorial Sloan Kettering Cancer Center (IDS Pharmacy)
Long Island City, New York, United States
Evelyn H. Lauder Breast and Imaging Center (BAIC).
New York, New York, United States
Memorial Sloan Kettering Cancer Center - Main Campus
New York, New York, United States
Sidney Kimmel Center for Prostate and Urological Cancers - Memorial Sloan Kettering Cancer Center
New York, New York, United States
University of Rochester Medical Center
Rochester, New York, United States
University of Rochester, Cancer Center Pharmacy (Investigational Product)
Rochester, New York, United States
Integrated Medical Professionals
Seaford, New York, United States
Montefiore Einstein Comprehensive Cancer Center
The Bronx, New York, United States
Montefiore Medical Center- Montefiore Medical Park
The Bronx, New York, United States
MSK Nassau.
Uniondale, New York, United States
Northwest Medical Specialties, PLLC
Bonney Lake, Washington, United States
Northwest Medical Specialties, PLLC
Federal Way, Washington, United States
Northwest Medical Specialties, PLLC
Gig Harbor, Washington, United States
Northwest Medical Specialties, PLLC
Puyallup, Washington, United States
Northwest Medical Specialties, PLLC
Tacoma, Washington, United States
Worth passing on?
Save it to the Care Package and send it to them, or to their doctor, in one message. Whether they follow it up is theirs to decide.
Review the Care PackageThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.