This trial is looking at the effectiveness of 177Lu-PSMA-617 in the treatment of castration-resistant (tumor grows even with hormone therapy) prostate cancer. The main outcome to be measured is overall survival.
The details
Prostate cancer is an uncontrolled growth of the cells which make up the prostate gland. Prostate cancer can be treated by medication, surgery or radiation. Medication aims to kill prostate cancer cells chemically. Surgery aims to cut out the cancerous prostate tissue. Radiation therapy uses radio waves to kill the cancerous prostate tissue. 177Lu-PSMA-617 is a type of internal radiotherapy that is being developed for patients whose cancer has spread in spite of hormonal therapy (metastatic castration-resistant prostate cancer; mCRPC).
This trial looks at the effectiveness of 177Lu-PSMA-617 for men with mCRPC compared to standard care. The main outcome to be measured is 2-year overall survival.
Who are they looking for?
750 patients are needed for this study. To be included in the trial, patients must have a positive PET/CT scan, must have progressive disease, and must have testosterone levels of less than 50 ng/dL. Patients must have recovered from side effects from previous treatments and must have adequate blood cell counts, liver, and kidney function. Patients and their partners must use suitable, barrier methods of birth control.
Patients who have received other types of radioactive particles less than 6 months before the trial are not allowed. Patients must not have a blood transfusion within 30 days of the trial. Patients who have had cancer in the brain must be fully treated and not on corticosteroids. Patients cannot have cord compression. Patients cannot have another serious illness, such as heart disease, uncontrolled infection, Hepatitis B or C and cannot have another cancer or a history of another cancer in the previous 3 years.
How will it work
Patients will be divided into two groups. Group 1 will receive 177Lu-PSMA-617 and the best standard of care. Group 2 will only receive the best standard of care. Patients will be assessed throughout the trial for cancer progression and side effects. Patients will be contacted every 3 months. This trial will last for 2 years.
