RecruitingPhase 2

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

United States30 participantsStarted 2024-05-31

Plain-language summary

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.

Who can participate

Age range18 Years

SexMALE

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Inclusion criteria

✓. Informed Consent: provision of signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
✓. Age greater than or equal to 18 years. Members of all races and ethnic groups will be included.
✓. Participants must have histologically confirmed non-metastatic adenocarcinoma of the prostate
✓. (a) Any one of the following three high risk features:
✓. No definitive evidence of metastasis on nuclear bone scan (required on all subjects)
✓. No evidence of lymph nodes \> 2 cm in diameter on pelvic CT scan (scan only required in patients with a PSA \> 20 ng/ml)
✓. Prostatectomy with extended lymph node dissection planned as primary therapy.
✓. Be willing to provide tissue from a diagnostic biopsy core or excisional biopsy of a tumor lesion obtained up to 6 months/180 days prior to initiation of treatment on Day 1. Subjects for whom samples cannot be provided (e.g., inaccessible or subject safety concern) may submit an older archived specimen only upon agreement from the Sponsor-Investigator.

Exclusion criteria

What they're measuring

Pathologic Complete Response or Minimal Residual Disease (MRD)

Timeframe: 5 months

Trial details

NCT IDNCT05593497

SponsorVA Office of Research and Development

Sponsor typeFED

Study typeINTERVENTIONAL

Primary completion2027-05-01

Contact for this trial

Ryan P Kopp, MD

(503) 220-8262 ryan.kopp@va.gov

View on ClinicalTrials.gov More High-Risk Prostate Cancer trials