Metastatic Castration Resistant Prostate Cancer Clinical Trial

About the Study

Metastatic prostate cancer that no longer responds to hormone therapy is called metastatic castration resistant prostate cancer (mCRPC).  This clinical trial may be an option for you if you have been diagnosed with mCRPC that has spread or gotten worse since your last treatment.  Participants will be randomly assigned to receive the current standard of care medicine, enzalutamide, or PF-06821497 (study medicine) orally in combination with enzalutamide.

What the Study Involves

The study team will meet with you to see if you are eligible to participate in this study. At your initial screening visit, the study team will ask questions about your cancer diagnosis and medical history, perform a physical exam, laboratory tests, CT/MRI scans and electrocardiogram (ECG), and possibly take a biopsy of your tumor. 

 The study medicine, PF-06821497, is an oral tablet taken twice a day in 21-day cycles until your cancer has gotten worse, disappeared, or you decide to leave the study. You will be able to continue taking the study medicine as long as you and your doctor believe it is a benefit to you. You will need to attend regular visits so the study team can monitor how you are responding to the medicine. These visits will include health assessments, questionnaires, blood samples, ECGs, CT/MRI scans, and optional tumor biopsies. You will also be asked to track your dose schedule in a diary.

You can change your mind at any time if you feel this study isn’t right for you.

Learn more.

Study Locations

This is a global clinical research study. There are 64 study sites planned in 3 countries worldwide, including:

• United States
• Russian Federation
• Spain

Key Inclusion Criteria

• Diagnosis of metastatic castration resistant prostate cancer (mCRPC)
• Participants must have evidence of disease through imaging
• Participants should have received abiraterone treatment (may have received up to 1 prior line of chemotherapy) and have not received prior enzalutamide, apalutamide or darolutamide and have evidence of prostate cancer progression
• Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1.
• Adequate organ function

Key Exclusion Criteria

• Normal heart rhythm that meets study requirements (ask your doctor)
• High blood pressure that cannot be controlled by medications (>150/90 mmHg despite optimal medical therapy).
• Known or suspected sensitivity to PF 06821497 (study drug) or any components or enzalutamide
• Active inflammatory gastrointestinal disease, chronic diarrhea, known diverticular disease or previous gastric resection or lap band surgery.