A Study of Risvutatug Rezetecan in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) [EMBOLD Prostate-302]
Condition(s) studied
Investigational drug(s) / intervention(s)
Risvutatug rezetecan (Ris-Rez): Risvutatug rezetecan (Ris-Rez) will be administered.
Enzalutamide: Enzalutamide will be administered.
Abiraterone: Abiraterone will be administered.
Prednisone: Prednisone will be administered along with Abiraterone.
Prednisolone: Prednisolone will be administered along with Abiraterone.
Study summary
This study aims to evaluate how well risvutatug rezetecan (Ris-Rez) works in treating prostate cancer compared to best supportive/standard of care (BSC) which may include a hormone therapy with an androgen receptor pathway inhibitors (ARPI), by checking whether it makes cancers smaller or disappear completely, if it helps participants live longer, and/or feel better. The study is also assessing whether Ris-Rez is safe and tolerated well by participants and aims to provide a better understanding of the side effects of the drug.
Eligibility
Primary outcome measure(s)
- Radiographic Progression-Free Survival (rPFS) per PCWG3 by BICR — Up to approximately 169 weeks
rPFS is defined as time from randomization to the first documented radiographic disease progression, per Prostate cancer clinical trials working group 3 (PCWG3) as assessed by Blinded Independent Central Review (BICR) or death due to any cause, whichever occurs first. - Overall Survival (OS) — Up to approximately 169 weeks
OS is defined as the time from randomization to date of death by any cause.
Trial sites (6)
| Facility | City | Region | Status |
|---|---|---|---|
| GSK Investigational Site | Auchenflower | Queensland | Recruiting |
| GSK Investigational Site | Montreal | Quebec | Recruiting |
| GSK Investigational Site | Tokyo | Japan | Recruiting |
| GSK Investigational Site | Tottori | Japan | Recruiting |
| GSK Investigational Site | Seoul | Seoul Teugbyeolsi | Recruiting |
| GSK Investigational Site | Gyeonggi-do | South Korea | Recruiting |
On this site
📄 Xtandi (enzalutamide) drug profile → 📄 Zytiga (abiraterone) drug profile → 📄 Deltasone (prednisone) drug profile →More GlaxoSmithKline trials in Canada
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07802704 on ClinicalTrials.gov ↗ ← All trials in Canada