CAPItello-280
Research type
Research Study
Full title
A Phase III Double-Blind, Randomised, Placebo-Controlled Study Assessing the Efficacy and Safety of Capivasertib + Docetaxel Versus Placebo + Docetaxel as Treatment for Patients with Metastatic Castration Resistant Prostate Cancer (mCRPC)
IRAS ID
1005000
Contact name
Marnie Duncan
Contact email
Sponsor organisation
AstraZeneca AB
Eudract number
2021-005201-27
Clinicaltrials.gov Identifier
Research summary
The purpose of this research study is to find out if a new medicine called capivasertib given with docetaxel (a standard of care medication) will work more effectively than docetaxel alone in treating patients with metastatic castration resistant prostate cancer. Capivasertib is not approved by any health authority, except for use in research studies. Participants will be randomly assigned a study treatment: either capivasertib + docetaxel or placebo + docetaxel. In addition to the study treatment patients will received corticosteroids with their docetaxel infusion and will be on a background of continuous androgen deprivation therapy (ADT).
Prostate cancer is the second most common cancer and the fifth leading cause of cancer death among men worldwide.
Approximately 790 patients will take part in this research study, with 395 patients in each group. The study will last approximately 6 years. Procedures will include, but are not limited to, blood tests, physical examinations, vital signs, electrocardiogram (a test to measure heart activity), questionnaires, CT/MRI and bone scans to measure the tumour and assess the extent of the cancer.
AstraZeneca AB are funding the research. The study is planned to run at 8 hospitals/cancer centres in the UK.
REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
22/EM/0068
Date of REC Opinion
4 May 2022
REC opinion
Further Information Favourable Opinion