Capivasertib + Abiraterone for Prostate Cancer

(CAPItello-281 Trial)

Recruiting at280 trial locations

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: AstraZeneca

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Research Team

Eligibility Criteria

Men with metastatic hormone-sensitive prostate cancer and PTEN deficiency, who can take abiraterone and steroids, are eligible. They must have a recent diagnosis (within 180 days), provide specific tissue samples, show evidence of metastasis, be on ADT treatment for up to 93 days before the trial starts, have an ECOG performance status of 0-1, and agree to contraception. Exclusions include brain metastases or spinal cord compression not stable without steroids for at least four weeks.

Inclusion Criteria

I can provide a tissue sample that is not from bone metastases.

I have completed the required pain and fatigue questionnaires.

I can take and keep down pills.

Exclusion Criteria

I cannot properly absorb medications due to my stomach or bowel condition.

I have not had major surgery in the last 4 weeks.

Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that, in the investigator's opinion, gives reasonable suspicion of a disease or condition that contra-indicates the use of an investigational drug, may affect the interpretation of the results, render the patient at high risk from treatment complications or interferes with obtaining informed consent

Treatment Details

Interventions

• Abiraterone Acetate (Hormone Therapy)
• Capivasertib (AKT Inhibitor)
• Placebo (Other)

Trial Overview The study is testing if adding Capivasertib to Abiraterone (+prednisone/prednisolone) along with ADT provides better outcomes than placebo plus Abiraterone (+prednisone/prednisolone) with ADT in men whose tumors lack PTEN protein. The main goal is improving time without disease progression using imaging criteria or until death from any cause.

Participant Groups

Group I: Capivasertib + Abiraterone Experimental Treatment 2 Interventions

Participants receive capivasertib in combination with abiraterone (prednisone/prednisolone) on a background of ADT.

Group II: Placebo + Abiraterone Placebo Group 2 Interventions

Participants receive placebo in combination with abiraterone (prednisone/prednisolone) on a background of ADT.

Abiraterone Acetate is already approved in Canada, Japan for the following indications:

Approved in Canada as Zytiga for:

• Metastatic castration-resistant prostate cancer
• Metastatic castration-sensitive prostate cancer

Approved in Japan as Zytiga for:

• Prostate cancer

Who Is Running the Clinical Trial?

AstraZeneca

Lead Sponsor

Trials

4,491

Recruited

290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology