Clinical Trial for Metastatic Castrate Resistant Prostate Cancer (mCRPC).

Who may participate

Each clinical study has its own guidelines for who may participate, called eligibility criteria. These factors can include your age, sex, overall health, type and stage of disease, and personal treatment history. However, only the research study staff can determine if you qualify to enroll in the study.

Condition

Metastatic Castrate Resistant Prostate Cancer (mCRPC)

Sex

Male

Age

18+ years

Healthy participants

Visit ClinicalTrials.gov for more information

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 surgical or medical castration with evidence of disease progression on treatment with abiraterone acetate in the mCSPC setting or first line mCRPC setting is required.
Eastern Cooperate Oncology Group (ECOG) performance status 0 - 2, with life expectancy of at least 6 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 may make the participant inappropriate for the study.
Know 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.
Prior treatment for prostate cancer at any stage with any cytotoxic chemotherapy, radioligand therapy (i.e. 177Lu-PSMA-617, radium 223), 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 agents, if discontinued prior to first dose of study intervention.
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 within 30 days or 5 half-lives preceding the first dose of study intervention (whichever is shorter).
Inadequate organ function.

Study overview

Pfizer MEVPRO-1 (C2321014) is a randomized, open-label, multi-center clinical trial evaluating whether combining the study medicine (PF-06821497) with enzalutamide is safe and effective compared to physician's choice of either second-line androgen receptor (AR) directed therapy with enzalutamide or docetaxel (chemotherapy) for treating metastatic castration-resistant prostate cancer (mCRPC) after progression on prior abiraterone acetate treatment.

The primary objective of this clinical trial is to assess the radiographic progression free survival (rPFS) of the combination of PF-06821497 plus enzalutamide versus physician's choice of enzalutamide or docetaxel.

View locations for this study

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Miles

0500

Nearest Locations found

50 sites found

AdventHealth Hematology and Oncology

Orlando, Florida, United States, 32804

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AdventHealth Orlando Infusion Center

Orlando, Florida, United States, 32804

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Colorado Clinical Research

Lakewood, Colorado, United States, 80228

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Duly Health and Care

Lisle, Illinois, United States, 60532

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Duly Health and Care

Westmont, Illinois, United States, 60559

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Florida Cancer Specialists

Bonita Springs, Florida, United States, 34135

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Florida Cancer Specialists

Bradenton, Florida, United States, 34211

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Florida Cancer Specialists

Cape Coral, Florida, United States, 33909

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Florida Cancer Specialists

Fort Myers, Florida, United States, 33905

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Florida Cancer Specialists

Fort Myers, Florida, United States, 33908

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Florida Cancer Specialists

N. Venice, Florida, United States, 34275

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Florida Cancer Specialists

Naples, Florida, United States, 34102

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Florida Cancer Specialists

Port Charlotte, Florida, United States, 33980

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Florida Cancer Specialists

Sarasota, Florida, United States, 34236

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