The University of Miami Adapt (UAdapt) Trial

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

Trial Details

NCT ID
NCT06111313
Phase
PHASE2
Sponsor
University of Miami
Status
RECRUITING
Cancer Type
Prostate Cancer
Interventions
  • FTLEAD
  • Ultra-Short-Term Androgen Deprivation Therapy with Relugolix
  • HypoLEAD
  • ADT Standard of Care
Locations (sample)
  • Miami, Florida, United States|25.77427,-80.19366

Key Eligibility Criteria

  • Biopsy confirmed adenocarcinoma of the prostate (including intraductal adenocarcinoma, excluding small cell carcinoma).
  • T1-T3 disease based on digital rectal exam (DRE), informed by mpMRI. Prostate MRI may aid in the staging evaluation by verifying organ-confined sta…
  • Patients with T3 disease based on DRE, mpMRI, Gleason 8-10, or a PSA of \>15 ng/mL, should undergo a negative metastatic workup prior to signing of…
  • No evidence of metastasis by clinical criteria or available radiographic tests (N0M0 by clinical or imaging criteria).

For full eligibility, visit ClinicalTrials.gov.

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