Phase 2 Prostate Cancer Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• You are willing to sign a consent form and take part in all parts of the study for its full duration
• You have been diagnosed with prostate cancer (adenocarcinoma) confirmed by a tissue or cell sample
• You were assigned male at birth and are 18 years of age or older (transgender women or gender-fluid individuals may also be eligible if they were born with a prostate and have not had testosterone-lowering treatment — confirm with trial site)
• Your testosterone level at the screening visit is above 100 ng/dL
• Your PSA (a prostate-related protein measured in blood) level at the screening visit is above 0.2 ng/mL
• You are able to swallow pills and take medication by mouth, and are willing to take daily medication if assigned to the treatment group
• If you could father a child, you agree to use condoms or another method of contraception (including abstinence) during radiation treatment and for 4 months after the last dose of study drug or radiation
• You agree to follow certain lifestyle guidelines throughout the study
• Your prostate cancer is classified as "favorable intermediate risk" with specific Gleason score and PSA combinations: either a Gleason score of 3+4 with a PSA below 20 ng/mL, or a Gleason score of 6 (3+3) with a PSA between 10 and 20 ng/mL (confirm with trial site)
• A special genetic test of your biopsy tissue (called a Decipher score) shows a result of 0.6 or higher, meaning higher genomic risk
• Your prostate size, measured by MRI or ultrasound within the last 120 days, is 80cc or smaller

Who may not be able to join:

• You are currently taking medications known to cause a heart rhythm problem called QT prolongation
• You have a known allergy to the drug relugolix
• You have received another experimental drug or prostate cancer treatment within 30 days of enrolling
• You have a history of ulcerative colitis or another inflammatory bowel disease
• You have a connective tissue disease such as lupus, scleroderma, or dermatomyositis
• Certain hormone-blocking therapy (GnRH antagonist) or a specific type of radiation treatment (SBRT to the prostate) is medically not suitable or not tolerated for you
• You have a documented history of a heart condition called long QT syndrome
• You have certain abnormal heart test (ECG) results, including: a recent heart attack (within the last 6 months), a QTc measurement above 470 msec (though people with a pacemaker may still be considered — confirm with trial site), or a condition called congenital long QT syndrome
• You have had your testicles surgically removed
• You have previously had surgery or radiation treatment directed at the prostate for prostate cancer

Important: Always verify eligibility with the trial site directly before applying.