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.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 …
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.
Trial Locations
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City
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Status
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…
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
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