Capivasertib + Abiraterone for Hormone Sensitive Prostate Cancer
Research type
Research Study
Full 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)
IRAS ID
281968
Contact name
Ananya Choudhury
Contact email
Sponsor organisation
AstraZeneca AB
Eudract number
2020-000346-33
Duration of Study in the UK
5 years, 9 months, 31 days
Research summary
This study aims to find out if an experimental combination of a new oral medication called capivasertib and the approved drug abiraterone can delay the worsening of metastatic prostate cancer compared with using abiraterone on its own.
Capivasertib inhibits a protein called AKT, increased AKT activity and its associated proteins have been shown to play a key part in promoting cancer growth. Inhibiting AKT could therefore reduce the chance of cancer growth. PTEN protein in the body normally acts to regulate AKT and decreased PTEN has been associated with worse cancer outcomes. The evidence available shows that capivasertib may work most effectively in patients whose cancers show a loss of PTEN protein, termed “PTEN deficiency”. Therefore, the main part of the study will only include patients who show loss of PTEN protein in the cancer.
Approximately 5500 men will take part in the first screening part of the study to assess PTEN status. About 1000 men are expected to have PTEN deficiency and continue into the next part of the study. Participants will be recruited from across the world from approximately 360 study sites.
Patients who meet the study criteria will be randomly assigned to receive capivasertib with abiraterone or placebo with abiraterone, with a one in two chance of receiving either combination treatment. The study involves 2 screening periods, a treatment period, and a follow up period. Patients who decide to take part in the study will have to attend for regular clinic visits for blood, urine and other safety tests to be performed along with scans for cancer measurement. Visits will occur every 2 weeks for the first 12 weeks after start of study treatment, then every 4 weeks for the first year, then every 8 weeks until treatment stops.REC name
South Central - Hampshire B Research Ethics Committee
REC reference
20/SC/0337
Date of REC Opinion
8 Dec 2020
REC opinion
Further Information Favourable Opinion