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:

• A person whose prostate cancer has been confirmed by a tissue biopsy showing a specific type called adenocarcinoma (a re-biopsy may be needed if the original biopsy is more than 12 months old)
• The cancer is considered a primary (original site) prostate cancer, confirmed by specific scans called PSMA-PET and mpMRI
• The cancer is classified as high-risk or very high-risk based on a standard set of medical guidelines (NCCN v1.2023)
• The person has signed a written consent form agreeing to take part in the study
• The person is older than 18 years
• The person has already had a PSMA-PET/CT scan, an mpMRI scan, or a combined PSMA-PET/MRI scan
• The cancer has been identified as high-risk by a type of artificial intelligence analysis called MMAI
• The person is in good to fully active physical condition, rated 0 or 1 on a standard health scale used by doctors (ECOG score)
• The person's urinary symptom score is 15 or below on a standard questionnaire (IPSS score)

Who may not be able to join:

• People who have previously had radiotherapy to the prostate or the pelvic area
• People who have previously had surgery to remove the prostate (radical prostatectomy)
• People who have previously had any focused/localised treatment directed at the prostate
• People whose scans show cancer has spread to lymph nodes in the pelvis
• People whose scans show cancer has spread to distant parts of the body
• People where more than 2 months passed between starting hormone therapy and having the PSMA-PET scan
• People whose scans show the cancer has grown into surrounding structures in a way classified as cT4 disease
• People whose PSA level was above 50 ng/ml before starting hormone therapy
• People whose life expectancy is estimated to be less than 5 years
• People who have hip replacements on both sides, or other implants that would significantly affect the quality of CT scan images
• People for whom an MRI scan is not safe or suitable
• People for whom HDR brachytherapy (a type of internal radiation treatment) is not considered feasible — for example, due to prostate size, shape, tumour location, or being unfit for anaesthesia
• People who have had certain prostate procedures (TURP or HoLEP) that left a significant tissue cavity, or who had such procedures within the 6 months before joining the trial
• People with medical conditions that would make radiotherapy unsafe — for example, active inflammatory bowel disease, or paralysis affecting the legs or body
• People who have had another cancer diagnosis within the last 2 years (except certain skin cancers), or whose previous cancer is likely to significantly affect their 5-year survival
• People with any other medical reason that makes external beam radiotherapy to the pelvis unsuitable
• People who have taken part in another interventional clinical trial within the 30 days before this trial begins
• People currently taking part in another interventional trial that could affect the results of this trial (participation in registry or diagnostic trials is permitted)
• People who do not have the legal capacity to understand what the trial involves and what it means for them
• People with a known or ongoing problem with misuse of medications, drugs, or alcohol

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