PhIII MK-5684 VS Alt AbirateroneAcetateOREnzalutamide Ptsw/mCRPC ThatProgressOnORAfter Tx w/One NHA

UCI Specialty Area: Cancer

Principal Investigator: Arash Rezazadeh Kalebasty

Official Title: A Phase III, Randomized, Open-label Study of MK-5684 versus Alternative Abiraterone Acetate or Enzalutamide in Participants with Metastatic Castration-resistant Prostate Cancer (mCRPC) That Progressed on or After Prior Treatment with One Next-generation Hormonal Agent (NHA)

A Study On:

Prostate

Study Description

The purpose of this study is to assess the efficacy and safety of opevesostat plus hormone replacement therapy (HRT) compared to alternative abiraterone acetate or enzalutamide in participants with Metastatic Castration-resistant Prostate Cancer (mCRPC) previously treated with one next-generation hormonal agent (NHA). The primary study hypotheses are that opevesostat is superior to alternative abiraterone acetate or enzalutamide with respect to radiographic progression free survival (rPFS) per Prostate Cancer Working Group (PCWG) Modified Response Evaluation Criteria in Solid Tumors (RECIST 1.1) as assessed by Blinded Independent Central Review (BICR) and overall survival (OS), in androgen receptor ligand binding domain (AR LBD) mutation positive and negative participants.

Eligibility

Have histologically or cytologically confirmed adenocarcinoma of the prostate without small cell histology
Has current evidence of metastatic disease documented by either bone lesions on bone scan and/or soft tissue disease shown by computed tomography scan (CT)/magnetic resonance imaging (MRI)
Has prostate cancer progression while receiving androgen deprivation therapy (ADT) (or post bilateral orchiectomy) within 6 months before screening

Has presence of gastrointestinal condition
Has poorly controlled diabetes mellitus
Has a history of active or unstable cardio/cerebro-vascular disease, including thromboembolic events

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University of California, Irvine - Study Information Sheet

UCI Center for Clinical Research Potential Participant Database

Lead Researcher
Maheswari Senthil, MD
UCI Center for Clinical Research

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