Phase 3 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 confirmed through biopsy or lab testing to have prostate adenocarcinoma (a specific type of prostate cancer)
• People who have had a specific type of nuclear imaging scan (PSMA PET/CT) that showed positive results, meaning the cancer showed up clearly on the scan with no areas that did not show up on the scan
• People whose PSA level (a prostate cancer marker measured in the blood) is above 2.0 ng/mL
• People whose prostate cancer has spread to other parts of the body, is no longer responding to hormone treatment, and is continuing to grow or spread — shown by rising PSA levels, growing tumours, or new bone lesions
• People who have had surgical removal of the testicles or are receiving ongoing hormone-suppressing treatment, and whose testosterone level in the blood is at a very low (castrate) level
• People who have previously been treated with at least one of the following hormone-blocking medications: apalutamide, darolutamide, enzalutamide, or abiraterone — and who stopped taking it at least 4 weeks before joining the trial
• People who have not previously received taxane-based chemotherapy (such as docetaxel or cabazitaxel) for their advanced hormone-resistant prostate cancer (prior docetaxel given for an earlier stage of prostate cancer is allowed if it was completed at least 12 months before joining)
• People who have recovered from significant side effects of previous cancer treatments, with side effects at a mild or manageable level
• People who have been on a stable dose of bone-protecting medication (bisphosphonate or denosumab) for at least 30 days before joining
• People aged 18 or older
• People who are well enough to carry out basic daily activities, based on a standard health performance scale (ECOG score of 2 or lower, meaning able to care for themselves but may not be able to do heavy physical work)
• People whose blood test results show healthy enough levels of white blood cells, platelets, and liver and kidney function (specific thresholds apply — confirm with trial site)
• People who do not have a blockage in the bile ducts or urinary tract
• People who have had brain metastases (cancer that has spread to the brain) that have already been treated and are stable, with no ongoing neurological symptoms and no need for steroids to manage brain swelling
• People living with HIV who are on effective HIV treatment and whose virus level in the blood has been undetectable within the past 6 months
• People with chronic hepatitis B who are on treatment and have an undetectable virus level in the blood
• People who have had hepatitis C and have been successfully treated and cured, or who are currently on hepatitis C treatment with an undetectable virus level
• People with a history of heart disease or past treatment with heart-affecting medications, provided that a doctor's assessment of heart function places them in Class II or better on the New York Heart Association scale (meaning heart disease causes only slight limitation during normal activity)
• People who are able to read and understand English or Spanish
• People who have completed 2 doses of a specific radioactive treatment called lutetium-177 PSMA therapy before the second stage of joining the trial
• People whose PSA level has dropped by 50% or more after the first two doses of the radioactive treatment (confirm timing details with trial site)

Who may not be able to join:

• People who have previously received certain types of radioactive treatments targeting bone (such as radium-223, strontium-89, samarium-153, or similar) within the 6 months before joining, or who have previously received any PSMA-targeted radioactive therapy at any time
• People who have received any systemic anti-cancer treatment (such as chemotherapy, immunotherapy, or biological therapies) within the 28 days before joining
• People who are currently taking any experimental medication or have done so within the 28 days before joining
• People who are currently receiving other chemotherapy, immunotherapy, radioactive therapy, or experimental treatments at the same time as this trial
• People who have a known allergic reaction to the medications used in this trial or to similar substances
• People who have received a blood transfusion within 30 days before joining
• People who have spinal cord compression (cancer pressing on the spinal cord) causing symptoms, or whose scans suggest this may be about to happen
• People whose brain metastases have not been treated or are not stable

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