The SUGAR Study; SBRT and Relugolix) for Prostate Cancer

The goal of this clinical trial is to measure the toxicity and effectiveness of the following treatments for cFIR/cgUIR prostate cancer patients. Stereotactic body radiotherapy (SBRT) alone or Stereotactic body radiotherapy (SBRT) combined with Ultrashort GNRH Antagonist called Relugolix (an oral drug). Treatments will be randomly assigned to study patients. The main questions it aims to answer are the following: 1. Whether the proportion of men who undergo SUGAR have superior rate of attaining PSA nadir of \<= 0.2 compared to SBRT alone, and 2. Whether SUGAR is superior to historical rates

Trial Details

NCT ID
NCT06111781
Phase
PHASE2
Sponsor
Yale University
Status
RECRUITING
Cancer Type
Prostate Cancer
Interventions
  • Relugolix 120 MG [Orgovyx]
  • SBRT standard of care radiotherapy treatment
Locations (sample)
  • New Haven, Connecticut, United States|41.30815,-72.92816
  • Lebanon, New Hampshire, United States|43.64229,-72.25176
  • New York, New York, United States|40.71427,-74.00597
  • Seattle, Washington, United States|47.60621,-122.33207

Key Eligibility Criteria

  • Provision of signed and dated informed consent form
  • Stated willingness to comply with all study procedures and availability for the duration of the study
  • Has histologically or cytologically confirmed diagnosis of adenocarcinoma of the prostate
  • Born assigned to Male gender, age 18 and above. Female identifying transgender or gender fluid are allowed on study provided they have not undergon…

For full eligibility, visit ClinicalTrials.gov.

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