This phase I trial studies intensity modulated radiation therapy (IMRT) with stereotactic radiosurgery boost and hormone therapy in treating patients with prostate cancer. Specialized radiation therapy, such as IMRT and stereotactic radiosurgery, that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Androgen hormones can cause the growth of prostate cancer cells and antihormone therapy drugs, such as leuprolide acetate, goserelin acetate, and bicalutamide, may lessen the amount of androgens made by the body. Giving IMRT with stereotactic radiosurgery boost and androgen deprivation therapy may be an effective treatment for prostate cancer.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02064036.
PRIMARY OBJECTIVE:
I. To assess the feasibility and safety of a treatment strategy incorporating whole pelvic IMRT followed by an stereotactic body radiation therapy (SBRT) (stereotactic radiosurgery [SRS]) boost to the prostate with neoadjuvant, concurrent, and adjuvant androgen deprivation for a total of 18-24 months for men with unfavorable intermediate or high risk localized prostate cancer.
SECONDARY OBJECTIVES:
I. To assess biochemical control at 24 months following the experimental treatment strategy by the “Phoenix definition”.
II. To assess toxicity of the experimental treatment approach as scored by the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
III. To assess motion of the prostate during the protracted delivery of hypofractionated radiotherapy as assessed by implanted electromagnetic (EM) transponder beacons.
OUTLINE:
Beginning 2 months prior to start of IMRT, patients receive leuprolide acetate intramuscularly (IM) or goserelin acetate subcutaneously (SC) monthly for 18-24 months. Patients also receive bicalutamide orally (PO) daily for 6 months in the absence of disease progression or unacceptable toxicity. Patients undergo IMRT 5 days a week on weeks 8-13. Within 7 days following IMRT, patients undergo stereotactic radiosurgery boosts in 2 fractions.
After completion of study treatment, patients are followed up every 6 months for 3 years and then yearly for 2 years.
Lead OrganizationUniversity of California Davis Comprehensive Cancer Center
Principal InvestigatorRichard K. Valicenti