Stereotactic Body Radiation Therapy in Treating Patients with Localized High-Risk Prostate Cancer

PRIMARY OBJECTIVES:

I. To establish the efficacy of stereotactic body radiation therapy (SBRT) in patients with high-risk localized prostate cancer compared to historical data from clinical trials.

II. To establish the safety with physician-reported outcomes after SBRT in patients with high risk localized prostate cancer.

III. To establish the quality of life with patient-reported validated questionnaires after SBRT in patients with high risk localized prostate cancer.

IV. To collect germ-line deoxyribonucleic acid (DNA) and nucleic acids from cancer patients to further investigate

the association and identify new germ-line mutations that impact cancer predisposition. (Germ-line substudy primary objective)

V. To investigate the role of germ-line mutations in predicting cancer outcome and response to therapy. (Germ-line substudy primary objective)

SECONDARY OBJECTIVES:

I. To determine the effect of the identified variants on tumor micro ribonucleic acid (miRNA), protein and gene expression. (Germ-line substudy secondary objective)

II. To study expression of DNA, ribonucleic acid (RNA) or protein in the blood of cancer patients with and

without variants of interest to discover correlations between such levels and the presence of cancer and/or

response to therapy in these patients. (Germ-line substudy secondary objective)

OUTLINE:

Patients undergo SBRT daily or every other day for a total of 5 fraction not exceeding 14 consecutive days. Patients may also receive androgen deprivation therapy for up to 9 months at the discretion of the treating physician.

After completion of study treatment, patients are followed up every 4 months for 1 year, every 6 months for 5 years, and then every 12 months thereafter.