Phase 1 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 have been diagnosed with prostate cancer (confirmed by a tissue sample within the last 180 days) that is considered "high risk" based on at least one of the following: the cancer has spread to certain nearby tissues (stage cT3a or higher), your PSA level is above 20 ng/mL, or your cancer scored an 8, 9, or 10 on the Gleason scale (Grade Group 4 or 5)
• You are 18 years of age or older
• Your doctors are planning to treat you with a precise, high-dose form of radiation therapy (called stereotactic ablative radiotherapy, or SabR) with an extra dose targeted at the tumor inside the prostate, along with hormone therapy to lower testosterone; your urinary symptom score must be 18 or below, and your prostate must be no larger than 100cc
• You have had a specific type of scan called a 68Ga PSMA-11 PET-CT or PET-MRI within the last 90 days, before starting any hormone therapy, and this scan showed no signs that the cancer has spread to distant parts of the body (small lymph nodes up to 1.5cm are allowed)
• Your PSMA-11 PET scan showed a clearly visible target area inside the prostate suitable for the extra radiation dose boost
• You agree to use effective contraception (such as hormonal methods, barrier methods, or abstinence) before joining, throughout the radiation treatment, and for 6 months afterward — and if your partner becomes pregnant during the study, she should contact her doctor immediately
• You are able to understand the study and are willing to sign a written consent form

Who may not be able to join:

• You have previously had surgery, radiation, or other treatments aimed at curing your prostate cancer (note: some prior hormone therapy may be allowed — confirm with trial site)
• Prior hormone therapy (ADT) may be allowed if it lasted less than 3 months, ended at least 3 months before joining, and your testosterone has returned to a normal level — or if ongoing hormone therapy has been used for 60 days or less and meets specific additional conditions (confirm with trial site)
• You are currently taking part in another clinical trial involving an experimental treatment for this cancer
• You have had an allergic reaction to the PSMA-11 68Ga imaging agent used in the scan
• You have a serious or uncontrolled illness — such as an active infection, heart failure, unstable chest pain, irregular heartbeat, or a mental health or personal situation that could make it difficult to follow the study requirements — as judged by the study doctor
• You have previously had radiation therapy to the pelvic area, unless it was only to the skin or a very shallow surface area

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