Apalutamide and Abiraterone Acetate in African American and Caucasian Men With Metastatic Castrate Resistant Prostate Cancer
Prospective Study of Apalutamide and Abiraterone Acetate iN ChemoTHerapy-Naïve mEn With mCRPC Stratified by Race
Sponsor: Daniel George, MD + Janssen Scientific Affairs, LLC
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Percentage of Participants With 2-Year Progression-Free Survival (PFS)
Time frame: every 12 weeks, up to 2 years
Secondary Endpoints
2-year PSA Progression Free Survival
Time to PSA Nadir
Percent of Men Who Achieve a PSA < 0.1
Eligibility Criteria
Inclusion Criteria: 1. Male, age ≥ 18 years 2. Karnofsky performance status ≥ 70 (Appendix 1) 3. Life expectancy of ≥ 12 months as determined by treating investigator 4. Written Authorization for Use and Release of Health and Research Study Information (HIPAA authorization per institutional requirements) 5. Willing/able to adhere to the prohibitions and restrictions specified in this protocol 6. Willing to take abiraterone acetate on an empty stomach, and should be able to swallow tablets whole, without crushing/chewing tablets. Must have the ability to swallow, retain, and absorb oral medication. 7. Medications known to lower the seizure threshold (see list under prohibited meds, appendix 2) must be discontinued or substituted at least 4 weeks prior to study entry 8. Agrees to use a condom (even men with vasectomies) and another effective method of birth control if he is having sex with a woman of childbearing potential or agrees to use a condom if he is having sex with a woman who i…
Read full criteria on CT.gov →✦ Analyst Commentary
Expert commentary on why this trial matters and what to watch for.
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