The SUGAR Study; SBRT and Relugolix) for Prostate Cancer
NCT ID: NCT06111781
Last Updated: 2026-01-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
60 participants
INTERVENTIONAL
2024-04-15
2028-02-29
Brief Summary
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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 a 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.
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Detailed Description
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Recent evidence suggests that androgen deprivation therapy (ADT) is generally beneficial for intermediate risk prostate cancer and so it is possible that these patients (with favorable intermediate risk based on non-genetic factors but with high genetic risk) may also benefit. However, ADT causes very bothersome side effects including hot flashes, fatigue, sexual disfunction, and in some cases, heart problems. In order to balance the benefit and harms of ADT in combination with radiation, we could reduce the length of ADT and make it precisely overlap with radiation treatment. The oral ADT medication Relugolix (Orgovyx) is ideal for this purpose. In addition to shortening ADT, it is important to measure any potential benefit when ADT is added to stereotactic body radiotherapy (SBRT). SBRT is a shorter and more intense version of standard fractionation EBRT.
Therefore, a multicenter randomized phase III study comparing prostate cancer control and quality of life with SBRT + Ultrashort GNRH Antagonist Relugolix (SUGAR) vs. SBRT alone for a category of clinicogenomic unfavorable intermediate risk patients with favorable clinical features and high risk genetic features.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
SBRT standard of care radiotherapy treatment
SBRT is a standard-of-care radiotherapy treatment for intermediate-risk prostate cancer.
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.
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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 \>150 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 tice 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) \<= 80 cc
Exclusion Criteria
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
18 Years
MALE
No
Sponsors
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Pfizer
INDUSTRY
Yale University
OTHER
Responsible Party
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Principal Investigators
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James Yu
Role: PRINCIPAL_INVESTIGATOR
Yale University
Locations
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Yale Cancer Center
New Haven, Connecticut, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
University of Washington
Seattle, Washington, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2000036163
Identifier Type: -
Identifier Source: org_study_id
No NIH funding
Identifier Type: OTHER
Identifier Source: secondary_id
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