RecruitingPhase IIMale onlyEN originalProstate cancerEarly / localized

The SUGAR Study; SBRT and Relugolix) for Prostate Cancer

⚠️

This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.

About the trial

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 of minimal clinically important decline (MCID) in sexual and hormonal function at 6 months for patients undergoing 6 months of androgen deprivation therapy (ADT) Men aged 18+ with cFIR/cgUIR will be enrolled. Specifically, patients must meet one of the following 2 criteria: 1) Gleason score must be Gleason 3+4 with a PSA \< 20 ng/mL, or 2) Gleason 6 (3+3) and PSA \> 10 ng/mL and \< 20 ng mL.

Original English text from ClinicalTrials.gov

Who can (and can't) join

✓ Qualifies

  • Mężczyzna w wieku 18 lat lub starszy (lub osoba transpłciowa urodzona z prostató, jeśli nie przyjmowała leczenia obniżającego testosteron)
  • Potwierdzony nowotwór złośliwy prostaty
  • Wynik biopsji: Gleason 3+4 z PSA < 20 ng/mL, lub Gleason 6 (3+3) z PSA > 10 ng/mL i < 20 ng/mL
  • Testosteron w krwi > 100 ng/dL
  • PSA w krwi > 0,2 ng/mL
  • Zdolność przyjmowania leków doustnie przez cały okres badania
  • Objętość prostaty ≤ 80 cc (zmierzona MRI lub ultrasound)
  • Gotowość do stosowania antykoncepcji przez cały czas leczenia i 4 miesiące po

✗ Disqualifies

  • Stosowanie leków wydłużających odstęp QT na EKG
  • Uczulenie na Relugolix
  • Poprzednie leczenie innych badań klinicznych w ostatnich 30 dniach
  • Historia zapalenia jelita grubego lub innych chorób zapalno-niezapalnych
  • Choroby tkanki łącznej (toczeń, skleroderma, zapalenie mięśni)
  • Wcześniejsze leczenie agonistami GNRH lub SBRT prostaty

Simplified criteria — AI translation

Trial details

Minimum age
18 Years
Last updated (source)
July 21, 2026
Sex
Male only

Therapies / drugs in trial

Locations (4)

Yale Cancer Center

New Haven, United States

Dartmouth-Hitchcock Medical Center

Lebanon, United States

Memorial Sloan Kettering Cancer Center

New York, United States

University of Washington

Seattle, United States

Trial contact

Contact information from ClinicalTrials.gov. Contact in English.

Share this trial

Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/22/2026.

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