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SBRT and Relugolix for the Treatment of Clinicogenomic Unfavorable Intermediate Risk Prostate Cancer, SUGAR Trial
Trial Status: active
This phase II trial compares the safety, side effects, and effectiveness of SBRT and relugolix (SUGAR) to SBRT alone in patients with clinicogenomic unfavorable intermediate risk prostate cancer. Clinicogenomic unfavorable intermediate risk prostate cancer has traditionally favorable features but has a high genomic risk score suggesting a higher risk of metastatic disease. SBRT is considered standard of care for the treatment of intermediate risk prostate cancer. SBRT is a type of external radiation therapy that uses special equipment to position a patient and precisely deliver radiation to tumors in the body (except the brain). The total dose of radiation is divided into smaller doses given over several days. This type of radiation therapy helps spare normal tissue. Relugolix is in a class of medications called gonadotropin-releasing hormone receptor (GNRH) antagonists. It works by decreasing the amount of testosterone (a male hormone) produced by the body. This may slow or stop the spread of prostate cancer cells that need testosterone to grow. Giving SBRT and relugolix may be more effective compared to SBRT alone in treating patients with clinicogenomic unfavorable intermediate risk prostate cancer.
Inclusion Criteria
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 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 genomic classifier (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 Criteria
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 electrocardiogram (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 principal investigator (PI)
* Congenital long QT syndromeQ
History of surgical castration
Prior treatment for prostate cancer with surgery or prostate directed radiotherapy
Additional locations may be listed on ClinicalTrials.gov for NCT06111781.
I. To test whether SUGAR is superior to SBRT in terms of the proportion of men achieving prostate specific antigen (PSA) nadir <= 0.02.
SECONDARY OBJECTIVE:
I. To test whether SUGAR is superior to the historical rate of avoiding sexual and hormonal minimal clinically important decline (MCID) recorded for 6 months of androgen deprivation therapy (ADT).
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients undergo standard of care SBRT for 5 treatments over 2 weeks. Patients undergo blood sample collection and computed tomography (CT) or magnetic resonance imaging (MRI) on study.
ARM II: Patients relugolix orally (PO) once daily (QD) for 30 days and undergo standard of care SBRT for 5 treatments over 2 weeks starting on day 15 of relugolix. Patients undergo blood sample collection and CT or MRI on study.
After completion of study treatment, patients are followed up at 30, 90, 180, 365 and 730 days.
