drugset / Trial / NCT06111313

The University of Miami Adapt (UAdapt) Trial

NCT06111313

Phase 2 Recruiting 130 enrolled University of Miami Varian Medical Systems · collab
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this prostate cancer research study is to investigate: 1. For early-stage patients, the use of a single session of high dose stereotactic body radiotherapy (SBRT) delivered to the tumor within the prostate, not to the entire prostate, as curative treatment of prostate cancer; 2. The addition of ultra short-term androgen supression (uSTAS) to a single session of high dose SBRT as a means of intensifying treatment while preserving quality of life and minimizing side effects; 3. The ability of a single session of high dose SBRT to activate your immune system to enhance eradication of prostate cancer; 4. For higher risk patients, the use of a single session of high dose SBRT to the tumor only followed by 25 sessions of radiotherapy targeting the whole prostate as a means to improve control of disease while preserving quality of life and minimizing side effects; 5. The relationship between diagnostic imaging studies and prostate biopsy results in assessing clinical outcomes; and 6. The relationship of pre- and post-treatment prostate biopsy results and imaging studies, such as MRI and PET/CT.

Timeline

Start
2024-11-06
Primary completion
2028-11-30
Completion
2033-11-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Relugolix Small molecule 120 mg Oral

Indications