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Ph III Capivasertib+Abiraterone vs Placebo+Abiraterone as Txt for Pts w/ De Novo Metastatic mHSPC

Arash Rezazadeh Kalebasty


A Study On:

  • Prostate

Status:

  • Open

Eligibility

Adult

Interested in joining this trial?

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

Details

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 Tumors (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.


Eligibility

You can join if...

Inclusion criteria:

  • Asymptomatic or mildly symptomatic, histologically-confirmed de novo metastatic hormone-sensitive prostate adenocarcinoma without small-cell tumours
  • A valid PTEN immunohistochemistry (IHC) result indicating PTEN deficiency
  • Metastatic disease documented prior to randomisation by clear evidence of >= 1 bone lesion and/or >= 1 soft tissue lesion accurately assessed at baseline and suitable for repeated assessment with CT and/or MRI.

Exclusion criteria:

  • Radiotherapy with a wide field of radiation within 4 weeks before the start of study treatment
  • Major surgery within 4 weeks of the start of study treatment
  • Serious cardiac illness or medical conditions
  • Brain metastases, or spinal cord compression

Get in touch with our study team