Capivasertib + Abiraterone for Prostate Cancer
(CAPItello-281 Trial)
What You Need to Know Before You Apply
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.
Will I have to stop taking my current medications?
The trial does not specify if you must stop taking your current medications, but it does mention that certain drugs, like strong inhibitors or inducers of CYP3A4, should be stopped 2-3 weeks before starting the study treatment. It's best to discuss your current medications with the study team to see if any adjustments are needed.
Is the combination of Capivasertib and Abiraterone safe for humans?
Abiraterone acetate, used in prostate cancer treatment, is generally well-tolerated but can cause side effects like low potassium levels, high blood pressure, fluid retention, and liver issues. The safety of Capivasertib in combination with Abiraterone specifically isn't detailed here, but Abiraterone alone has an acceptable safety profile in clinical settings.12345
What makes the drug Capivasertib + Abiraterone unique for prostate cancer treatment?
What data supports the effectiveness of the drug Capivasertib + Abiraterone for prostate cancer?
Are You a Good Fit for This Trial?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive capivasertib plus abiraterone (prednisone/prednisolone) plus ADT or placebo plus abiraterone (prednisone/prednisolone) plus ADT
Follow-up
Participants are monitored for safety and effectiveness after treatment, including radiographic progression-free survival and overall survival
What Are the Treatments Tested in This Trial?
Interventions
- Abiraterone Acetate
- Capivasertib
- Placebo
Abiraterone Acetate is already approved in United States, European Union, Canada, Japan for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
AstraZeneca
Lead Sponsor
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