Phase 2 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 aged 18 or older.
• People who have been diagnosed with prostate cancer (a specific type called adenocarcinoma), confirmed through a tissue sample.
• People whose cancer is considered high-risk, based on a biopsy score of Gleason Score 8 or higher (also called Grade Group 4 or above). People with cancer that has spread to nearby lymph nodes in the pelvis area may also be eligible.
• People whose pre-treatment scan (a specific type called a PET/CT 68Ga-PSMA-11 scan) shows high levels of a protein called PSMA in the prostate, with no cancer activity detected elsewhere in the body on a different type of scan (FDG PET).
• People who are willing and able to have surgery.
• People whose life expectancy is estimated to be greater than 10 years, as assessed by the treating doctor using recognised medical tools.
• People with a general health and activity level rated between 0 and 2 on a standard medical scale (meaning fully active to capable of limited self-care).
• People who agree to use reliable contraception (such as a condom plus one additional method with a failure rate below 1% per year) and to avoid donating sperm during treatment and for 14 weeks after the last dose. People whose partner is pregnant must use a condom or remain abstinent during this same period. (Note: methods such as calendar tracking or withdrawal are not considered reliable enough for this trial.)
• People who are able and willing to attend all required follow-up visits and stick to the treatment plan.
• People who are able to give informed consent (understand and agree to participate).

Who may not be able to join:

• People who have previously received any treatment for prostate cancer.
• People who have previously received PSMA-targeted radioligand therapy, or certain other radioactive treatments (including Strontium-89, Samarium-153, Rhenium-186, Rhenium-188, Radium-223, or wide-field radiation) within 6 months of joining the trial.
• People whose cancer has spread beyond the local lymph nodes to distant parts of the body.
• People with significantly low blood cell counts (low white blood cells, infection-fighting cells, or platelets), indicating bone marrow problems.
• People with significantly impaired liver function, based on blood test results above certain thresholds.
• People with significantly reduced kidney function (a filtering rate below 40 mL/min), or who are taking medications that can harm the kidneys.
• People with serious other health conditions that would make surgery unsafe or unsuitable.
• People with evidence that the cancer has spread to other parts of the body, including bones, organs, or distant lymph nodes.
• People who have previously had radiation therapy or hormone therapy for prostate cancer.
• People with a history of bleeding disorders or who are currently taking blood-thinning medication.
• People with active infections or other conditions that would make surgery unsafe.
• People who are unable or unwilling to give informed consent.
• People who are unable to attend follow-up visits or follow the required treatment plan.

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