This phase II trial studies how well androgen deprivation therapy, docetaxel, external beam radiation therapy, and stereotactic body radiation therapy work in treating patients with prostate cancer. Androgen deprivation therapy, such as leuprolide acetate, triptorelin, degarelix, and bicalutamide may lessen the amount of androgen made by the body. Drugs used in the chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. External beam radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method can kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Giving androgen deprivation therapy, docetaxel, external beam radiation therapy, and stereotactic body radiation therapy may work better in treating patients with prostate cancer.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03043807.
PRIMARY OBJECTIVE:
I. To assess the efficacy of treating men with oligometastatic prostate cancer with the following therapy: (1st) systemic chemo-hormonal therapy with up to 6-months (around 24 weeks) of adjuvant androgen deprivation and up to 6 cycles of chemotherapy, (2nd) definitive local tumor control with adjuvant radiation therapy, and (3rd) consolidative stereotactic radiation to oligometastatic lesions.
SECONDARY OBJECTIVES:
I. Safety.
II. Time to prostate specific antigen (PSA) recurrence.
OUTLINE:
Patients receive androgen deprivation therapy including leuprolide acetate intramuscularly (IM) or subcutaneously (SC), triptorelin IM, degarelix SC, or bicalutamide orally (PO) daily every 3 months for 2 years in the absence of disease progression or unacceptable toxicity. Patients also receive docetaxel intravenously (IV) over 1 hour on day 1. Treatment with docetaxel repeats every 3 weeks for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Within 1-2 months, patients undergo external beam radiation therapy (EBRT) over 3 weeks. During or right after EBRT, patients then undergo stereotactic body radiation therapy (SBRT) over 1-5 weeks.
After completion of study treatment, patients are followed up every 3 and 6 months for 48 months.
Lead OrganizationJohns Hopkins University/Sidney Kimmel Cancer Center
Principal InvestigatorKenneth James Pienta