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

Part of paid clinical trials in West Los Angeles, California.

Sponsor
VA Office of Research and Development
Study ID
NCT05593497
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • High-Risk Prostate Cancer

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Capivasertib — DRUG
    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).
  • abiraterone acetate — DRUG
    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.

Study Details

The purpose of this study is to learn about how an investigational drug intervention completed before doing prostate surgery (specifically, radical prostatectomy with lymph node dissection) may help in treatment of high risk localized prostate cancers that are most resistant to standard treatments. This is a phase II research study. For this study, capivasertib, the study drug, will be taken with intensified androgen deprivation drugs (iADT; abiraterone and leuprolide) prior to radical prostatectomy. This study drug treatment will be evaluated to see if it is effective in shrinking and destroying prostate cancer tumors prior to surgery and to further evaluate its safety prior to prostate cancer surgery.

Key Dates

Start date
May 31, 2024
Status verified
Mar 2026
Primary completion
May 1, 2027
Completion
Aug 1, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Single Arm
    neoadjuvant capivasertib combined with androgen receptor pathway therapy (leuprolide + abiraterone) prior to radical prostatectomy

Primary Outcome Measure

Pathologic Complete Response or Minimal Residual Disease (MRD) [ Time Frame: 5 months ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
VA Greater Los Angeles Healthcare System, West Los Angeles, CAWest Los AngelesCalifornia90073-1003
Matthew B Rettig, MD
[email protected]
310-478-3711
Samantha M Tran
[email protected]
3104783711
James J. Peters VA Medical Center, Bronx, NYThe BronxNew York10468-3904
Izak Faiena, MD
[email protected]
Amelia Kiliveros
[email protected]
VA Portland Health Care System, Portland, ORPortlandOregon97207-2964
Ryan P Kopp, MD
[email protected]
503-220-8262
Laura Onstad, RN
[email protected]
(503) 721-1060
Ryan P Kopp, MD (PRINCIPAL_INVESTIGATOR)
Ralph H. Johnson VA Medical Center, Charleston, SCCharlestonSouth Carolina29401-5703
Steven Savage, MD
843-789-7816
Elina Bolukbasi, RN
8435775011
South Texas Health Care System, San Antonio, TXSan AntonioTexas78229-4404-
VA Puget Sound Health Care System Seattle Division, Seattle, WASeattleWashington98108-1532
Robert B Montgomery, MD
[email protected]
206-277-6878
Makayla L Dejong
[email protected]
2062774527

Find similar trials in West Los Angeles, CA

By research site
VA Greater Los Angeles Healthcare System, West Los Angeles, CA· West Los Angeles, CAJames J. Peters VA Medical Center, Bronx, NY· The Bronx, NYVA Portland Health Care System, Portland, OR· Portland, ORRalph H. Johnson VA Medical Center, Charleston, SC· Charleston, SCSouth Texas Health Care System, San Antonio, TX· San Antonio, TXVA Puget Sound Health Care System Seattle Division, Seattle, WA· Seattle, WA

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