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 De Novo Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) Characterised by PTEN deficiency (CAPItello-281)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-504998-20-00

Acronym

D361BC00001

Enrollment

271

Registered

2024-06-21

Start date

2020-09-18

Completion date

Unknown

Last updated

2025-11-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic Hormone-sensitive Prostate Cancer Characterised by PTEN deficiency

Brief summary

1.Radiographic Progression-free Survival (rPFS) in patients with PTENdeficient Per Response Evaluation Criteria in Solid Tumors Version 1.1(RECIST 1.1) for soft tissue and/or Prostate Cancer Working Group 3(PCWG3) for bone as Assessed by the Investigator

Detailed description

1.To compare the effect of capivasertib+abiraterone relative to placebo+abiraterone by assessment of overall survival 2.To compare the effect of capivasertib+abiraterone relative to placebo+abiraterone by assessment of time to start of first subsequent therapy or death (TFST), 3.To compare the effect of capivasertib+abiraterone relative to placebo+abiraterone by assessment of time to start symptomatic skeletal event-free survival (SSE-FS) 4.To compare the effect of capivasertib+abiraterone relative to placebo+abiraterone by assessment of time to pain progression (TTPP), 5.To evaluate the PK of capivasertib in combination with abiraterone 6.To evaluate safety and tolerability assessment of capivasertib+abiraterone as compared to placebo+abiraterone in patients with PTEN-deficient mHSPC

Interventions

DRUGCapivasertib

DRUGPlacebo for capivasertib film-coated tablet for oral use

DRUGABIRATERONE ACETATE

Eligibility

Sex/Gender

Male

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
1.Radiographic Progression-free Survival (rPFS) in patients with PTENdeficient Per Response Evaluation Criteria in Solid Tumors Version 1.1(RECIST 1.1) for soft tissue and/or Prostate Cancer Working Group 3(PCWG3) for bone as Assessed by the Investigator	—

Secondary

Measure	Time frame
1.To compare the effect of capivasertib+abiraterone relative to placebo+abiraterone by assessment of overall survival 2.To compare the effect of capivasertib+abiraterone relative to placebo+abiraterone by assessment of time to start of first subsequent therapy or death (TFST), 3.To compare the effect of capivasertib+abiraterone relative to placebo+abiraterone by assessment of time to start symptomatic skeletal event-free survival (SSE-FS) 4.To compare the effect of capivasertib+abiraterone relative to placebo+abiraterone by assessment of time to pain progression (TTPP), 5.To evaluate the PK of capivasertib in combination with abiraterone 6.To evaluate safety and tolerability assessment of capivasertib+abiraterone as compared to placebo+abiraterone in patients with PTEN-deficient mHSPC	—

Measure

Time frame

—

Countries

Belgium, Bulgaria, Czechia, France, Germany, Netherlands, Poland, Slovakia, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026