This randomized phase III trial studies how well ultra-hypofractionated stereotactic body radiation therapy alone works compared to ultra-hypofractionated stereotactic body radiation therapy and short course degarelix in treating patients with intermediate-risk prostate cancer. Ultra-hypofractionated 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. Testosterone can cause the growth of prostate cancer cells. Hormone therapy using degarelix may fight prostate cancer by lowering the amount of testosterone the body makes. Giving ultra-hypofractionated stereotactic body radiation therapy and a short course of degarelix may work better in treating patients with prostate cancer.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03056638.
PRIMARY OBJECTIVES:
I. To compare 24-30 month post-stereotactic body radiation therapy (SBRT) prostate 12 core biopsy outcomes between intermediate risk patients treated with SBRT and short course androgen deprivation therapy (ADT) versus SBRT alone.
SECONDARY OBJECTIVES:
I. To assess whether the addition of 6 months of ADT with high dose SBRT decreases incident rates of biochemical failure and distant failure, or improves survival rate for intermediate risk prostate cancer patients compared to SBRT alone.
II. To assess the differences in short-term and long-term quality of life outcomes by comparing Expanded Prostate Cancer Index Composite (EPIC)-26, International Prostate Symptom Score (IPSS), and Short Form (SF)-12 survey results between intermediate risk prostate cancer patients treated with SBRT + short course ADT versus SBRT alone.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM 1: Patients receive degarelix subcutaneously (SC) every 28 days for 6 months in the absence of disease progression or unacceptable toxicity. Following 3 months of treatment with degarelix, patients undergo ultra-hypofractionated SBRT every other day (QOD) for 5 fractions.
ARM 2: Patients receive ultra-hypofractionated SBRT as in Arm 1.
After completion of study treatment, patients are followed up every 6 months for 2 years.
Lead OrganizationMemorial Sloan Kettering Cancer Center
Principal InvestigatorMichael J. Zelefsky