Prostate CancerPhase 2NCT06111781
The SUGAR Study; SBRT and Relugolix) for Prostate Cancer
A Phase 2 study testing Relugolix 120 MG [Orgovyx] in people with Prostate Cancer, run by Yale University at 4 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Relugolix 120 MG [Orgovyx]
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 4 sitesUnited States
- Study dates
- 15 Apr 2024to Feb 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 4 recruiting
- Recruiting
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
Nirav Kapadia, MD, MS, cancer.research.nurse@hitchcock.org
Nirav Kapadia, MD, MS
- Recruiting
Yale Cancer Center
New Haven, Connecticut, 06520
Amanda Davis, 4753217899, amanda.davis@yale.edu
Yi An, MD
- Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10017
Luz Tovar-Schultz, tovarral@mskcc.org
James Robert Janopaul-Naylor, MD
- Recruiting
University of Washington
Seattle, Washington, 98109
Ting Martin Ma, MD, 206-606-7318, mma1@uw.edu
Nazleen Patel-Ejarque, MPH, 206-616-3916, nazpatel@uw.edu
About this study
Official title: The SUGAR Study: (SBRT and Ultrashort GnRH Antagonist-Relugolix) for Clinicogenomic Unfavorable Intermediate Risk Prostate Cancer
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.
Read more
The main questions it aims to answer are the following:
- Whether the proportion of men who undergo SUGAR have superior rate of attaining PSA nadir of <= 0.2 compared to SBRT alone, and
- 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.
Read the detailed description
Unfavorable Intermediate Risk (UIR) Prostate Cancer is prostate cancer that is localized and curable but may require more treatment than external beam radiotherapy (EBRT) alone. In contrast, favorable intermediate risk (FIR) prostate cancer can be treated by EBRT alone. There is evidence that some prostate cancer that is classified through clinical factors as FIR can act more aggressively if also associated with a high risk gene expression score. This type of prostate cancer (traditionally favorable intermediate risk, but with a gene signature that predicts for aggressive disease) presents a treatment dilemma.
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 II 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
- Prostate Cancer
- Being tested
- Relugolix 120 MG [Orgovyx], SBRT standard of care radiotherapy treatment
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Relugolix 120 MG [Orgovyx]Drug
Also called SBRT standard of care radiotherapy treatment and Relugolix
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 treatmentRadiation
SBRT is a standard-of-care radiotherapy treatment for intermediate-risk prostate cancer.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Relugolix 120 MG [Orgovyx]; Radiation: SBRT standard of care radiotherapy treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 2 years post treatment
Secondary outcomes (1)
Change in Quality of life assessment using the EPIC-26 survey
The EPIC-26 is a validated instrument that measures health-related quality of life over 5 domains: Urinary incontinence, Urinary irritative/obstructive, Bowel, Sexual, Hormonal. Range of scores are 0-100. Higher scores indicate higher quality of life.
Measured: up to 2 years post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2023
- Study start15 Apr 2024
- Primary completionFeb 2028 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Sponsor
- Investigators
- James Yu, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06111781
- Sponsor's protocol ID
- 2000036163
- Other IDs
- No NIH funding
- Status last verified
- Sep 2026
- First submitted
- 26 Oct 2023
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The SUGAR Study: (SBRT and Ultrashort GnRH Antagonist-Relugolix) for Clinicogenomic Unfavorable Intermediate Risk Prostate Cancer
- ClinicalTrials.gov ID
- NCT06111781
- Acronym / sponsor ID
- 2000036163
- Conditions
- Prostate Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- 15 Apr 2024 (actual)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 1 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Whether the proportion of men who undergo SUGAR have superior rate of attaining PSA nadir of <= 0.2 compared to SBRT alone, and
- 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.
Detailed description
Unfavorable Intermediate Risk (UIR) Prostate Cancer is prostate cancer that is localized and curable but may require more treatment than external beam radiotherapy (EBRT) alone. In contrast, favorable intermediate risk (FIR) prostate cancer can be treated by EBRT alone. There is evidence that some prostate cancer that is classified through clinical factors as FIR can act more aggressively if also associated with a high risk gene expression score. This type of prostate cancer (traditionally favorable intermediate risk, but with a gene signature that predicts for aggressive disease) presents a treatment dilemma.
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 II 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Stereotactic body radiotherapy | Active comparator | Radiation: SBRT standard of care radiotherapy treatmentSBRT 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. |
| Relugolix and SBRT | Active comparator | Drug: Relugolix 120 MG [Orgovyx], Radiation: SBRT standard of care radiotherapy treatmentSBRT 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Relugolix 120 MG [Orgovyx]Also: SBRT standard of care radiotherapy treatment and RelugolixORGOVYX 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. | Drug | Relugolix and SBRT |
| SBRT standard of care radiotherapy treatmentSBRT is a standard-of-care radiotherapy treatment for intermediate-risk prostate cancer. | Radiation | Relugolix and SBRT, Stereotactic body radiotherapy |
Primary outcome
Proportion of participants that attain PSA nadir
Time frame: up to 2 years post treatment
The proportion of men who undergo SUGAR that attain PSA nadir of <= 0.2ng/mL compared to SBRT alone.
1 secondary outcome
Change in Quality of life assessment using the EPIC-26 survey
Time frame: up to 2 years post treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
James Yu principal investigator
Yale University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Relugolix 120 MG [Orgovyx] in people with Prostate Cancer, run by Yale University at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Camalene Chrysostoum (2037375851, camalene.chrysostoum@yale.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants that attain PSA nadir (time frame: up to 2 years post treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.