A Single-Arm Phase II Study of Neoadjuvant Intensified Androgen Deprivation (Leuprolide and Abiraterone Acetate) in Combination With AKT Inhibition (Capivasertib) for High-Risk Localized Prostate Cancer With PTEN Loss

PHASE2RecruitingINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

May 31, 2024

Primary Completion Date

May 1, 2027

Study Completion Date

August 1, 2027

Conditions
High-Risk Prostate Cancer
Interventions
DRUG

Capivasertib

400 mg (2 tablets) BID given on an intermittent weekly dosing schedule. Patients will be dosed on Days 1 to 4 in each week (4 days on, 3 days off). Treatment will be given in combination with abiraterone for 16 weeks duration (+/- 1 week for surgery window).

DRUG

abiraterone acetate

"Administered orally as tablets at a dosage of 1000 mg daily. To be administered with prednisone 5mg po daily.~Subjects will be on concurrent GNRH agonist therapy (leuprolide, administered as standard of care). Intensified androgen deprivation (iADT) consisting of abiraterone and leuprolide will be administered for a 4 week run-in prior to addition of capivasertib."

Trial Locations (6)

90073-1003

RECRUITING

VA Greater Los Angeles Healthcare System, West Los Angeles, CA, West Los Angeles

10468-3904

RECRUITING

James J. Peters VA Medical Center, Bronx, NY, The Bronx

97207-2964

RECRUITING

VA Portland Health Care System, Portland, OR, Portland

29401-5703

RECRUITING

Ralph H. Johnson VA Medical Center, Charleston, SC, Charleston

78229-4404

TERMINATED

South Texas Health Care System, San Antonio, TX, San Antonio

98108-1532

RECRUITING

VA Puget Sound Health Care System Seattle Division, Seattle, WA, Seattle

All Listed Sponsors
lead

VA Office of Research and Development

FED