Phase 1 Prostate Cancer Trial, Recruiting

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

Who might be able to join this trial:

• People who have been diagnosed with prostate adenocarcinoma (a specific type of prostate cancer), confirmed by a tissue or cell sample taken within the past year, with final confirmation done at MD Anderson Cancer Center.
• People whose cancer is at a locally contained stage — not too advanced based on physical exam or imaging (specific staging categories: cT1c through T3a, but not cT3b or T4, under standard cancer staging guidelines).
• People whose cancer falls within a moderate-to-high aggressiveness range on the Gleason grading scale (Grade Groups 2 through 5, covering Gleason scores 7, 8, 9, or 10).
• People with a Gleason Grade Group 2 diagnosis must also meet at least one sign of higher risk — either a certain tumor stage (cT2b) or a PSA level above 10 ng/mL before starting hormone therapy (note: if someone is taking a medication called a 5-alpha reductase inhibitor, the measured PSA level may be doubled for this calculation).
• People whose cancer has not spread to the lymph nodes, based on standard imaging.
• People who are 18 years of age or older at the time of signing the consent form.
• People who have already started hormone therapy (androgen deprivation therapy) may still be eligible, as long as that therapy began no more than 185 days before registering for the trial — and a baseline PSA reading must have been taken before hormone therapy started.
• People with a general health/activity level rated 0, 1, or 2 on a standard medical scale (ECOG scale), meaning they are able to carry out most daily activities (confirm with trial site).

Who may not be able to join:

• People who have an active condition such as scleroderma, lupus, or a similar connective tissue or autoimmune disease that the treating radiation specialist considers too risky for radiation therapy.
• People who have previously had surgery to remove the prostate, or had cryotherapy (freezing treatment) or HIFU (high-intensity focused ultrasound) for prostate cancer.
• People who have previously received radiation therapy to the same area of the body in a way that would cause the old and new radiation fields to overlap.
• People whose cancer has spread to distant parts of the body (metastatic disease), as seen on standard imaging, and where the treating doctor determines it cannot be fully treated.

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