🏛️ Verified NIH Record • Updated 2026-07-17

The SUGAR Study; SBRT and Relugolix) for Prostate Cancer (NCT06111781)

The SUGAR Study: (SBRT and Ultrashort GnRH Antagonist-Relugolix) for Clinicogenomic Unfavorable Intermediate Risk Prostate Cancer

🟢 Recruiting Phase2 💊 Investigational Drug / Biologic Sponsor: Yale University

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (12 items) and avoid the listed exclusions (14 items).

Location: Yale Cancer Center — New Haven, Connecticut

Age range: 18 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

  • Exclusion Criteria:
  • Current use of medications that cause QT prolongation
  • Known allergic reactions to relugolix
  • Treatment with another investigational drug or other intervention for prostate cancer within 30 days of enrollment
  • Ulcerative colitis or other inflammatory bowel disease history
  • Connective tissue disease such as lupus, scleroderma, or dermatomyositis
  • GNRH antagonist therapy or SBRT to the prostate are medically contraindicated or not tolerated
  • History of long QT syndrome documented in the medical record
  • The following ECG abnormalities are excluded:
  • Q-wave infarction unless identified 6 or more months before the Screening Visit
  • QT interval corrected for heart rate (QTc) \> 470 msec. If the QTc is prolonged in a patient with a pacemaker, the patient may be enrolled in the study upon discussion with the study PI
  • Congenital long QT syndromeQ

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (4 Sites)

  • Yale Cancer Center — New Haven, Connecticut
  • Dartmouth-Hitchcock Medical Center — Lebanon, New Hampshire
  • Memorial Sloan Kettering Cancer Center — New York, New York
  • University of Washington — Seattle, Washington

📞 Contact the Study Coordinator

Phone: (203) 737-5851

Email: camalene.chrysostoum@yale.edu

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

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💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗