Capivasertib+Abiraterone as Treatment for Patients With Metastatic Hormone-sensitive Prostate Cancer and PTEN Deficiency

Official Title

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 PTEN Deficiency.

Summary:

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. The intention of the study is to demonstrate that in participants with mHSPC, the combination of capivasertib plus abiraterone (+prednisone/prednisolone) plus ADT is superior to placebo plus abiraterone (+prednisone/prednisolone) plus ADT in participants with mHSPC characterised by PTEN deficiency with respect to radiographic progression-free survival (rPFS) per 1) Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 for soft tissue and/or Prostate Cancer Working Group (PCWG3) for bone as assessed by the investigator 2) death due to any cause.

Trial Description

Primary Outcome:

• Radiographic Progression-free Survival (rPFS)

• Overall survival (OS)
• Time to Start of First Subsequent Therapy or Death (TFST)
• Symptomatic Skeletal Event-Free Survival (SSE-FS)
• Time to Pain Progression (TTPP)
• Time to PSA progression
• Time To Castration Resistance (TTCR)
• Fatigue intensity, severity and interference domains assessed by the Brief Fatigue Inventory (BFI)
• Overall Pain Severity and Pain Interference as assessed by BPI-SF questionnaire
• Disease-Related Symptoms and HRQoL using the Functional Assessment of Cancer Therapy - Prostate Cancer (FACT-P) questionnaire
• Progression-Free Survival after next-line treatment (PFS2)
• Plasma concentration of capivasertib pre-dose
• Plasma concentration of capivasertib 1h post-dose
• Plasma concentration of capivasertib 4h post-dose

View this trial on ClinicalTrials.gov