This phase I/II trial studies the side effects of stereotactic body radiation therapy (SBRT), also known as stereotactic radiosurgery, and hormone therapy and how well they work in treating patients with localized intermediate-risk prostate cancer. 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. Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as goserelin acetate, leuprolide acetate, and bicalutamide, may lessen the amount of androgens made by the body. Giving SBRT and hormone therapy may be an effective treatment for prostate cancer.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT01517451.
PRIMARY OBJECTIVES:
I. Assess 5-year biochemical failure free rate (BFFR) associated with the combined hypofractionated dose regimen and androgen deprivation therapy (ADT).
SECONDARY OBJECTIVES:
I. Assess the incidence of grade 3 or greater late genitourinary (GU) and gastrointestinal (GI) toxicity and self-reported quality of life data.
II. Assess clinical and pathologic control rates associated with the combined hypofractionated dose regimen and ADT using Kaplan-Meier estimates.
III. Collect dose/volume and imaging data to allow normal tissue complication probability modeling and targeting assessment for patients treated with hypofractionated radiation therapy.
IV. Collect whole blood to perform correlative studies for serum cytokine profiling and future biomarker studies.
OUTLINE: This is a phase I, dose-escalation study of SBRT followed by a phase II study.
ADT: Patients undergo ADT comprising goserelin acetate, leuprolide acetate, or triptorelin for 2 months and bicalutamide orally (PO) for at least 2 weeks prior to the initiation of radiation therapy and for 2 months after completion of radiation therapy. Patients may continue to receive bicalutamide through radiation therapy at the discretion of the treating physician.
SBRT: Patients undergo 5 fractions of SBRT every other day over 2 weeks.
After completion of study treatment, patients are followed up at 3 and 6 months, every 6 months until 3 years, and then annually until year 5.
Lead OrganizationJohns Hopkins University/Sidney Kimmel Cancer Center
Principal InvestigatorDaniel Yeong-Jin Song
