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:

• Adults aged 18 or older
• People whose overall health and ability to carry out daily activities is rated at a good level (a score of 0 or 1 on a standard oncology scale)
• People whose surgical notes confirm that both nerve bundles alongside the prostate were successfully preserved during their prostate removal surgery
• People whose records confirm that their prostate removal surgery was performed using a technique that stays close to or within the tissue layers surrounding the prostate
• People who have been diagnosed with prostate cancer (a specific type called adenocarcinoma) and had their prostate surgically removed as the main treatment, with pathology results showing either no cancer spread to lymph nodes, or lymph nodes that were not examined
• People whose imaging scan (using PSMA PET or a specific tracer called Axumin) showed no signs of cancer that has spread to nearby or distant areas of the body
• People with a PSA blood test result of 0.1 ng/mL or higher
• People who are planning to receive radiation therapy directed at the area where the prostate used to be
• People who have provided written consent to participate before enrolling in the study

Who may not be able to join:

• People with a known allergy to hyaluronic acid
• People whose pathology results showed the cancer had grown into nearby structures beyond the prostate (classified as T4 disease)
• People who previously received other local prostate cancer treatments such as cryotherapy (freezing treatment) or brachytherapy (internal radiation seeds)
• People who have already received radiation therapy to the prostate area or pelvis after their prostate removal surgery
• People for whom radiation to the pelvic lymph nodes is planned as part of their treatment
• People who have had prior surgery on the lower bowel or rectum (such as removal of part of the large intestine or the rectum itself)
• People with inflammatory bowel conditions such as Crohn's disease or ulcerative colitis that require steroid medication to manage
• People with an active connective tissue disorder such as lupus or scleroderma
• People with any abnormality in the urinary or genital area that could make it difficult to reach the injection site for the procedure (confirm with trial site)
• People whose white blood cell count falls outside the acceptable range in blood tests
• People with a haemoglobin level (a measure of red blood cells) below 10 g/dL, though blood transfusion or other medical steps to raise this level may make participation possible
• People with an active bleeding disorder or blood clotting problems based on specific blood test results (confirm with trial site)
• People with liver enzyme levels (AST/ALT) more than 2.5 times the accepted upper limit based on standard lab ranges
• People with a creatinine level above 2.0 mg/dL, which relates to kidney function
• People with a bilirubin level above 2.0 mg/dL, which relates to liver function
• People with a history of chronic kidney failure
• People with a history of poorly controlled diabetes, including blood sugar that cannot be managed with medication or a fasting blood sugar level above 300 mg/dL
• People with a history of AIDS; however, people with HIV that is well controlled (with certain immune cell counts at an acceptable level and no history of serious HIV-related infections) may be considered
• People who are unable to have an MRI or PSMA/PET scan, for example due to having a medical device that is not compatible with MRI
• People with hip implants on both sides; a single hip implant on one side may be acceptable if it is MRI-compatible and does not interfere with the study scans (confirm with trial site)
• People who are unable or unwilling to follow the requirements of the study
• People who, in the opinion of the trial doctor, have any condition that would prevent them from safely completing the study treatment

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