The SUGAR Study; SBRT and Relugolix) for Prostate Cancer

NCT06111781 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: 2000036163No NIH funding
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 3

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. 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. 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)

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Proportion of participants that attain PSA nadir

  The proportion of men who undergo SUGAR that attain PSA nadir of \<= 0.2ng/mL compared to SBRT alone.

  up to 2 years post treatment

Secondary Outcomes (1)

• Change in Quality of life assessment using the EPIC-26 survey

  up to 2 years post treatment

Study Arms (2)

Stereotactic body radiotherapy

ACTIVE COMPARATOR

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.

Radiation: SBRT standard of care radiotherapy treatment

Relugolix and SBRT

ACTIVE COMPARATOR

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.

Drug: Relugolix 120 MG [Orgovyx]; Radiation: SBRT standard of care radiotherapy treatment

Interventions

Relugolix 120 MG [Orgovyx] DRUG

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.

Also known as: SBRT standard of care radiotherapy treatment and Relugolix

Relugolix and SBRT

SBRT standard of care radiotherapy treatment RADIATION

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

Relugolix and SBRT; Stereotactic body radiotherapy

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Born assigned to Male gender
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 undergone testosterone suppressing therapy and were born with a prostate.
• Has a serum testosterone at the Screening visit of \>100 ng/dL
• Has a serum PSA concentration at the Screening visit of \> 0.2 ng/mL
• 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).
• 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
• Agreement to adhere to Lifestyle Considerations (see section 5.3) throughout study duration
• 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.
• Decipher GC score of 0.6 or higher or higher indicating high genomic risk for most recent biopsy
• Documented prostate volume (by MRI or ultrasound within 120 days or physician attestation within 120 days) \<= 80 cc

You may not qualify if:

• 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
• History of surgical castration
• Prior treatment for prostate cancer with surgery or prostate directed radiotherapy

Sponsors & Collaborators

• Yale University: lead
• Pfizer: collaborator

Study Sites (3)

Yale Cancer Center

New Haven, Connecticut, 06520, United States

RECRUITING

Memorial Sloan Kettering Cancer Center

New York, New York, 10017, United States

RECRUITING

University of Washington

Seattle, Washington, 98109, United States

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

relugolix

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• James Yu

  Yale University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Camalene Chrysostoum

CONTACT

860-714-4568; camalene.chrysostoum@yale.edu

Tara McPartland

CONTACT

860-714-4568; tara.mcpartland@yale.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will undergo baseline tests at the beginning of the study and will be randomized to receive Stereotactic body radiotherapy (SBRT) + Ultrashort GNRH Antagonist Relugolix (SUGAR) vs. Stereotactic body radiotherapy (SBRT) alone.

Study Record Dates

• First Submitted: October 26, 2023
• First Posted: November 1, 2023
• Study Start: April 15, 2024
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2028
• Last Updated: May 11, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)