Recruiting
Phase 2

SBRT & Relugolix

Sponsor:

Yale University

Code:

NCT06111781

Conditions

Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Relugolix 120 MG [Orgovyx]

SBRT standard of care radiotherapy treatment

Study Details

Brief summary:

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.

Conditions

Prostate Cancer

Study ID

NCT06111781

Start date

Apr 15, 2024

Status verified date

Jul, 2026

Completion date

Feb, 2028

Anticipated

Primary completion date

Feb, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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 gender, age 18 and above. Female identifying transgender or gender fluid are allowed on study provided they have not undergone testosterone suppressing therapy and were born with a prostate.
5. Has a serum testosterone at the Screening visit of >100 ng/dL
6. Has a serum PSA concentration at the Screening visit of > 0.2 ng/mL
7. Able to swallow pills and take medication orally (no documented inability to eat solids and swallow pills) and be willing to adhere to the daily regimen of medication (if assigned to the experimental arm).
8. For patients of reproductive potential: use of condoms or other methods (including abstinence) to ensure effective contraception with partner during radiotherapy and through 4 months after the last dose of the study drug or radiotherapy
9. Agreement to adhere to Lifestyle Considerations (see section 5.3) throughout study duration
10. Clinical favorable intermediate risk prostate cancer: Gleason score must be Gleason 3+4 with a PSA < 20 ng/mL, or Gleason 6 (3+3) and PSA > 10 ng/mL and < 20 ng mL.
11. Decipher GC score of 0.6 or higher or higher indicating high genomic risk for most recent biopsy
12. Documented prostate volume (by MRI or ultrasound within 120 days or physician attestation within 120 days) <= 80 cc

Exclusion Criteria:

1. Current use of medications that cause QT prolongation
2. Known allergic reactions to relugolix
3. Treatment with another investigational drug or other intervention for prostate cancer within 30 days of enrollment
4. Ulcerative colitis or other inflammatory bowel disease history
5. Connective tissue disease such as lupus, scleroderma, or dermatomyositis
6. GNRH antagonist therapy or SBRT to the prostate are medically contraindicated or not tolerated
7. History of long QT syndrome documented in the medical record
8. The following ECG abnormalities are excluded:

1. Q-wave infarction unless identified 6 or more months before the Screening Visit
2. 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
3. Congenital long QT syndromeQ
9. History of surgical castration
10. Prior treatment for prostate cancer with surgery or prostate directed radiotherapy

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Stereotactic body radiotherapy

SBRT Though a range of doses are delivered nationally for IR prostate cancer, the most common regimen is 7.25 Gy- 8.00 Gy x 5 fractions, given over 2 weeks.

active comparator: Relugolix and SBRT

SBRT and Relugolix SBRT along with 30 days of total relugolix (study drug) will be used. Relugolix starting 14 days to 17 days prior to the first treatment.

Interventions

Relugolix 120 MG [Orgovyx]

ORGOVYX will be initiated with a loading dose of 360 mg on the first day and continue treatment with a 120 mg dose taken orally once daily at approximately the same time each day. Total length of treatment will be 30 days.

SBRT standard of care radiotherapy treatment

SBRT is a standard-of-care radiotherapy treatment for intermediate-risk prostate cancer.

Primary outcome measure

  • Proportion of participants that attain PSA nadir [ Time Frame: up to 2 years post treatment ]

Central Contacts and Locations

Central contacts

Locations

Yale Cancer Center

Recruiting

New Haven, Connecticut, United States, 06520

Contacts

Principal Investigator:

Yi An, MD

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10017

Contacts

Luz Tovar-Schultz

tovarral@mskcc.org

Principal Investigator:

James Robert Janopaul-Naylor, MD

University of Washington

Recruiting

Seattle, Washington, United States, 98109

Contacts

Ting Martin Ma, MD

206-606-7318mma1@uw.edu

Nazleen Patel-Ejarque, MPH

206-616-3916nazpatel@uw.edu

Principal Investigator:

Ting Martin Ma, MD

More Information

Sponsor

Yale University

Last update posted

Jul 21, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Yale University on 2026-07-21.