Capivasertib + Docetaxel for Prostate Cancer

(CAPItello280 Trial)

Recruiting in Palo Alto (17 mi)

+204 other 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 docetaxel versus placebo plus docetaxel in participants with metastatic castration resistant prostate cancer (mCRPC), all participants will receive the docetaxel with steroid therapy and receive androgen deprivation therapy. The intention of the study is to demonstrate that the combination of capivasertib plus docetaxel is superior to placebo plus docetaxel with respect to the overall survival and/or the radiographic progression free survival of study participants.

Eligibility Criteria

Men with advanced prostate cancer that's resistant to hormone therapy and has spread, despite previous treatments like abiraterone or enzalutamide. They should be fit for chemotherapy, have no severe heart issues or other serious illnesses, and must not have had certain recent surgeries or other cancer treatments.

Inclusion Criteria

I am mostly active and doctors expect me to live at least 12 more weeks.

My cancer has spread to my bones or soft tissues.

I have a suitable tissue sample from my tumor for testing.

Exclusion Criteria

I am not taking any medications that greatly affect my heart's rhythm.

I have not had major surgery in the last 4 weeks, except for minor procedures.

I don't have active brain tumors or spinal issues needing steroids.

Participant Groups

The trial is testing if adding Capivasertib to standard Docetaxel chemotherapy improves survival in men with metastatic castration-resistant prostate cancer compared to placebo plus Docetaxel. All participants will continue hormone therapy alongside the study drugs.

Group I: capivasertib + docetaxel Experimental Treatment 2 Interventions

Participants receive capivasertib in combination with docetaxel and steroids on a background of ADT.

Group II: placebo + docetaxel Placebo Group 2 Interventions

Participants receive placebo in combination with docetaxel and steroids on a background of ADT.

Capivasertib is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Truqap for:

• Hormone receptor-positive, HER2-negative locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN-alterations

🇪🇺 Approved in European Union as Truqap for:

• Locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN alterations

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Research Site Cerritos, CA

Research Site Santa Barbara, CA

Research Site White Plains, NY

Research Site Burlington, VT

More Trial Locations

Who Is Running the Clinical Trial?

AstraZeneca Lead Sponsor

References