A Phase III Double-Blind, Randomised, Placebo-Controlled Study Assessing The Efficacy And Safety Of Capivasertib+Abiraterone Versus Placebo+Abiraterone As Treatment For Patients With Denovo Metastatic Hormone-Sensitive Prostate Cancer Characterised By Pte
Posted Date: Oct 19, 2021
- Investigator: Shuchi Gulati
- Specialties:
- Type of Study: Drug
This study will assess the efficacy and safety of capivasertib plus abiraterone (+prednisone/prednisolone) plus androgen deprivation therapy (ADT) versus placebo plus abiraterone (+prednisone/prednisolone) plus ADT in participants with mHSPC whose tumours are characterised by PTEN deficiency. There are 2 arms in this study. In arm 1, Participants will receive capivasertib in combination with abiraterone (prednisone/prednisolone) on a background of ADT. In arm 2, Participants will receive placebo in combination with abiraterone (prednisone/prednisolone) on a background of ADT. Efficacy will be determined by Radiographic Progression-free Survival.
Criteria:
Asymptomatic Or Mildly Symptomatic, Histologically-Confirmed De Novo Metastatic Hormone-Sensitive Prostate Adenocarcinoma Without Small-Cell Tumours. A Valid Pten Ihc Result Indicating Pten Deficiency (Centralized Testing). Metastatic Disease Documented P
Keywords:
Phase 3, Gu, Cancer
For More Information:
Uc Cancer Center
5135847698
cancer@uchealth.com