Status:
RECRUITING
The SUGAR Study; SBRT and Relugolix) for Prostate Cancer
Lead Sponsor:
Yale University
Collaborating Sponsors:
Pfizer
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
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 Stereo...
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...
Eligibility Criteria
Inclusion
- 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 \>150 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 tice 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) \<= 80 cc
Exclusion
- 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
Key Trial Info
Start Date :
April 15 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2028
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06111781
Start Date
April 15 2024
End Date
February 1 2028
Last Update
December 3 2025
Active Locations (3)
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1
Yale Cancer Center
New Haven, Connecticut, United States, 06520
2
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10017
3
University of Washington
Seattle, Washington, United States, 98109