Investigating PF-06821497 for men with advanced prostate cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This global, multicenter, randomized Phase 3 study aims to evaluate the effectiveness of PF-06821497 (mevrometostat) in combination with enzalutamide compared to a placebo with enzalutamide in men with metastatic castration-resistant prostate cancer (mCRPC). Participants will be screened and randomized to receive either the investigational drug or placebo alongside standard treatment. The study will include a Screening Phase, Randomization, Treatment Phase, Safety Follow-up, and Long-Term Follow-up to assess the drug's efficacy and safety. Eligible participants must have confirmed prostate cancer and meet specific health criteria.

Why it matters

Who can join: the full rules

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.

Where it's running

• Ironwood Cancer & Research Centers
  Chandler, Arizona, United States Recruiting
• Ironwood Cancer & Research Centers
  Gilbert, Arizona, United States Recruiting
• Palo Verde Hematology Oncology
  Glendale, Arizona, United States Recruiting
• Ironwood Cancer & Research Centers
  Glendale, Arizona, United States Recruiting
• Ironwood Cancer & Research Centers
  Goodyear, Arizona, United States Recruiting
• Ironwood Cancer & Research Centers
  Mesa, Arizona, United States Recruiting

+181 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Pfizer CT.gov Call Center
• Email: ClinicalTrials.gov_Inquiries@pfizer.com
• Phone: 1-800-718-1021

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Dual-target PSMA/PSCA CAR-NK Therapy in Advanced Prostate Cancer

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.