This phase II trial based in Dallas, Texas aims to determine the effect of immunotherapy and stereotactic ablative body radiation as a metastatic hormone-resistant prostate cancer treatment. The main outcome to be investigated is time from treatment until cancer progression.
Metastatic prostate cancer is cancer that has spread out from the tumor to the rest of the body. Hormone therapy is a common treatment used. It targets the male sex hormones active in prostate cancer, such as testosterone. Hormone-resistance can occur in some patients. This means patients will no longer respond to hormone therapy.
Sipuleucel- T (Provenge) is an immunotherapy drug (boosts the immune response) that is used to treat metastatic prostate cancer. Stereotactic ablative body radiation (SABR) is a radiation treatment that targets the tumor site by applying radiation beams from different directions to maximize radiation exposure.
This study will evaluate the efficacy of these treatments by determining time from treatment until cancer progression.
Who are they looking for?
This study is recruiting 41 men over the age of 18 years who have confirmed metastatic prostate cancer and who are currently receiving hormone therapy. Ideal candidates will only be experiencing mild symptoms if any, and will be physically and mentally capable. Patients should have adequate kidney and liver function.
Patients cannot take part in this trial if they have received more than 2 different types of chemotherapy or have confirmed brain tumors as a result of prostate cancer. Candidates with additional malignant or severe illnesses, injuries or those receiving immunotherapy or takings steroids will not be considered for this trial.
How will it work
Patients will be treated with a combination of Sipuleucel-T and SABR until cancer progresses.