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NCT05593497 · ClinicalTrials.gov registry record · Phase 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
A Phase 2 study of High-risk Prostate Cancer, sponsored by VA Office of Research and Development.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 30
- Enrollment target
- 6
- Study locations
NCT05593497: Recruiting Phase 2 study of High-risk Prostate Cancer, sponsored by VA Office of Research and Development.
NCT05593497 is a Phase 2 study of High-risk Prostate Cancer that is actively recruiting participants, run by VA Office of Research and Development. The registered enrollment target is 30 participants, below the 51-participant average among 4 other High-risk Prostate Cancer trials with a reported enrollment target (41% lower). The trial reports 6 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05593497, a Phase 2 study of High-risk Prostate Cancer, is actively recruiting participants, sponsored by VA Office of Research and Development.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 30 participants
- Enrollment target
- 6
- Study locations
Study 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.
Primary Outcome
No cancer detected on radical prostatectomy specimen, or minimal residual disease 5mm.
Conditions Studied
Interventions
- DRUG abiraterone acetate
- DRUG Capivasertib
Study Locations (6)
California
- VA Greater Los Angeles Healthcare System, West Los Angeles, CA - West Los Angeles
New York
- James J. Peters VA Medical Center, Bronx, NY - The Bronx
Oregon
- VA Portland Health Care System, Portland, OR - Portland
South Carolina
- Ralph H. Johnson VA Medical Center, Charleston, SC - Charleston
Texas
- South Texas Health Care System, San Antonio, TX - San Antonio
Washington
- VA Puget Sound Health Care System Seattle Division, Seattle, WA - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2024-05-31 |
| Est. Completion | 2027-08-01 |
| Phase | Phase 2 |
What NCT05593497 shows while recruiting
NCT05593497 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 51-participant average among 4 other High-risk Prostate Cancer trials with a reported enrollment target (41% lower).
The record links to 1 condition, with High-risk Prostate Cancer appearing as the primary indexed condition, and to 2 interventions - of which abiraterone acetate is the first listed.
NCT05593497 lists 6 locations in 6 states (California, New York, Oregon).
Frequently Asked Questions
What is clinical trial NCT05593497 about?
NCT05593497 is a clinical study titled "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. ...
What is the current status of trial NCT05593497?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2024-05-31. Estimated completion is 2027-08-01.
What conditions does trial NCT05593497 study?
This clinical trial studies the following conditions: High-risk Prostate Cancer.
What interventions are being tested in trial NCT05593497?
The interventions under investigation include: abiraterone acetate (DRUG), Capivasertib (DRUG).
Who is sponsoring clinical trial NCT05593497?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05593497 being conducted?
This trial has 6 study locations across California, New York, Oregon, South Carolina, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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