drugset / Trial / NCT05574712
A Neoadjuvant Study of Abiraterone Acetate, Leuprolide Acetate, and Belzutifan in Men With Regional Prostate Cancer
NaSingle-groupOpen-labelTreatment
Summary
For men with prostate cancer that involves the nearby lymph nodes (N1) standard treatment varies. Many men undergo radical prostatectomy (total removal of the prostate) along with the removal of nearby lymph nodes. Other men may opt for androgen deprivation therapy (ADT, a therapy that blocks testosterone) using the two drugs leuprolide and abiraterone - with or without radiation. This research is being done to investigate whether the use of leuprolide and abiraterone, when given in combination with a drug that blocks a molecule that senses oxygen needs by cancer cells, belzutifan, can kill cancer cells in the body prior in men who are planning on having the prostate surgically removed.
Timeline
- Start
- 2024-01-01
- Primary completion
- 2025-01
- Completion
- 2026-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Abiraterone acetate | Small molecule | 1000 mg | Oral |
| Subject | Belzutifan | Small molecule | 120 mg | Oral |
| Subject | Leuprolide | Other / unclassified | 22.5 mg | Subcutaneous |
| Background | Prednisone | Other / unclassified | 5 mg | Oral |