SBRT and Relugolix for Prostate Cancer

The SUGAR Study; SBRT and Relugolix) for Prostate Cancer

Recruiting Phase 2 Interventional Study
Prostate Cancer
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 and older
Sex
Male
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
60 (estimated)
Sponsor
Yale University · Other
Who this trial is looking for

This trial is looking for men aged 18 and older with certain types of prostate cancer. Participants will receive either Stereotactic body radiotherapy or that treatment combined with an oral medication called Relugolix to see how effective they are.

Are You a Good Fit for This Trial?

You may be able to join if

  • I have been diagnosed with prostate cancer.
  • I am 18 years old or older.
  • I have a Gleason score of 3+4 and a PSA level less than 20 ng/mL.
  • I have a Gleason score of 6 (3+3) and a PSA level between 10 and 20 ng/mL.
  • I am willing to comply with all study procedures.
  • I can swallow pills and take medication orally.
  • I have a serum testosterone level above 100 ng/dL.
  • I agree to use effective contraception if I have a partner.

You may not be able to join if

  • I have a known allergy to Relugolix.
  • I have been treated with another prostate cancer drug within the last 30 days.
  • I have a history of ulcerative colitis or other inflammatory bowel diseases.
  • I have a connective tissue disease.
  • I have been castrated surgically in the past.
  • I have had surgery or radiotherapy for prostate cancer before.
  • I have a history of long QT syndrome.
  • I am currently taking medications that can cause QT prolongation.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This 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 …
Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Provision of signed and dated informed consent form 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. Has histologically or cytologically confirmed diagnosis of adenocarcinoma of the prostate 4. Born assigned to Male g…
Contacts

Camalene Chrysostoum

2037375851

camalene.chrysostoum@yale.edu

CONTACT

Tara McPartland

2037377173

tara.mcpartland@yale.edu

CONTACT