This phase 2 trial will investigate the effectiveness of stereotactic ablative radiation therapy (SABR) and radiopharmaceutical therapy (RPT) in patients with oligometastatic (cancer spread in 1-2 other tissues or organs) prostate cancer.
The main outcome will be progression-free survival (PFS). This trial is recruiting in Maryland, US.
Stereotactic ablative radiation therapy (SABR) is a type of radiotherapy (RT). It uses a high dose of radiation and targets a specific area from different angles. SABR is an effective treatment for prostate cancer (PC). However, SABR cannot target multiple tumors at the same time. Some tumors may go undetected. Systemic RT may target these tumors. Radiopharmaceutical therapy (RPT) uses radioactive drugs to treat the whole body. Combining SABR and RPT may improve cancer treatment.
This trial will investigate the effectiveness of SABR and RT. The main outcome will be PFS.
Who are they looking for?
This trial will recruit 64 patients with PC. Participants must have at least one tumor in another organ metastasis. Patients must have a life expectancy of at least 12 months. The primary tumor must have been treated with surgery and/or radiation. Patients must have adequate organ and bone marrow function testosterone levels higher than 125 ng/dl and a PSA between 0.5 and 50.
Participants cannot have received more than 3 years of androgen deprivation therapy (ADT). Patients with castration-resistant prostate cancer (CRPC) cannot take part in the trial. Other exclusion criteria are secondary tumors in the liver or lungs and abiraterone/prednisone treatment. Patients receiving another trial drug cannot participate.
How will it work
Patients will be assigned to one of 2 groups. One group will receive SABR only. The other group will receive SABR and RPT. RPT will be performed with radium-223.