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

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 destroy

Trial Details

NCT ID
NCT05593497
Phase
PHASE2
Sponsor
VA Office of Research and Development
Status
RECRUITING
Cancer Type
Prostate Cancer
Interventions
  • Capivasertib
  • abiraterone acetate
Locations (sample)
  • West Los Angeles, California, United States|34.0462,-118.43068
  • Chicago, Illinois, United States|41.85003,-87.65005
  • St Louis, Missouri, United States|38.62727,-90.19789
  • The Bronx, New York, United States|40.84985,-73.86641
  • Portland, Oregon, United States|45.52345,-122.67621

Key Eligibility Criteria

  • Informed Consent: provision of signed informed consent, which includes compliance with the requirements and restrictions listed in the informed con…
  • 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:

For full eligibility, visit ClinicalTrials.gov.

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