A Phase 3, 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)
Volunteers
Health Professionals
What is the purpose of this trial?
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.
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Principal Investigator
Sub-Investigators
- Agatha Hecht
- Alessia Donadio, MD
- Alison Johnson
- Andrea Brennan
- Armand Russo, MD
- Beverly Drucker, MD, PhD
- D. Barry Boyd, MD, MS
- Elan Gorshein, DO, JD, MPH
- Emily Kopas, APRN, OCN
- Harold Tara Jr, MD
- James Vredenburgh, MD
- Jane Kanowitz, MD
- Jeremy Kortmansky, MD
- Johanna LaSala, MD
- Jose Morales-Marin
- Joseph Kim, MD
- Karishma Mehra, MBBS
- Kayla Martello
- Kristen Hoxie
- Larisa Fleysher
- Laura Sabourin
- Lynn Mastrianni
- M. Sung Lee, MD
- Madeline Santiago
- Michael Hurwitz, MD, PhD
- Michelle Laspino
- Neal Fischbach, MD
- Osarugue Otasowie
- Pawan Karanam, MD
- Renee Moye
- Robert Matera, MD
- Sara Anastasio, RN
- Sarah Carlson
- Su Hsien Lim, MD
- Vidya Kesavan
- Virginia Syombathy
- Wajih Kidwai, MD, FACP
- Yifei Zhang, MD
- Zia Rahman, MD
- Last Updated11/14/2024
- Study HIC#2000037609