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RecruitingPhase 3

A Study to Learn How PF-06821497 (Mevrometostat) Works in Men With Metastatic Castration-resistant Prostate Cancer.

A PHASE 3, RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED STUDY OF PF-06821497 (MEVROMETOSTAT) WITH ENZALUTAMIDE IN METASTATIC CASTRATION RESISTANT PROSTATE CANCER (MEVPRO-2)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Male only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether PF-06821497 (mevrometostat) plus enzalutamide works better than enzalutamide alone. It is for men whose prostate cancer has spread and keeps growing despite treatment to lower testosterone, and who have not taken androgen receptor-blocking drugs or abiraterone.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Tests of tissue or cells show prostate adenocarcinoma, a type of prostate cancer, with no small cell features.
  • Scans show that the cancer has spread to bones or soft tissues.
  • The cancer is getting worse despite medicines or surgery to lower testosterone.
  • You can do all or most daily activities, and the study doctor expects you to live at least 12 months.

Who can't join

  • A health condition, mental health condition, or abnormal lab result makes the study unsuitable for you. This includes suicidal thoughts within the past year or suicidal behavior within the past 5 years.
  • You have a history of active bowel inflammation, long-term diarrhea, surgery to remove part or all of your stomach, or lap-band weight-loss surgery.
  • You have serious heart or blood vessel disease.
  • Cancer is known or suspected to have spread to your brain, or is active in the lining around your brain or spinal cord. A significant history of seizures also rules you out.
  • You have ever had myelodysplastic syndrome (a blood cell disorder), acute myeloid leukemia (a blood cancer), or another cancer, with a few exceptions.
  • You have had treatment for prostate cancer after it spread and stopped responding to testosterone-lowering treatment, or certain other prostate cancer drugs. Some hormone treatments are allowed. Earlier docetaxel is allowed if the cancer still responded to hormone treatment and did not worsen during docetaxel or within 3 months after it ended.
  • You received an experimental drug or vaccine too close to the first study dose: within 30 days or within 5 drug half-lives, whichever is longer. A half-life is the time it takes for half a drug to leave the body.
  • Your organs do not work well enough for the study.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 in the past year or suicidal behavior in the past 5 years 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, estrogens, progestins, cyproterone acetate; 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 sites (39)

AR

AZ

CA

IL

NM

NY

SC

TX

WA