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.

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.

Inclusion Criteria:

- Histologically confirmed primary non-metastatic adenocarcinoma of the prostate

- Risk-group classification into the D’Amico or National Comprehensive Cancer Network
(NCCN) ‘high-risk’ group, as defined by the presence of any one of the following
high-risk factors:

- Pre-biopsy prostate-specific antigen (PSA) >= 20

- Biopsy Gleason score 8-10

- Clinical stage T3

- No pelvic nodal metastases (based on computed tomography [CT] or magnetic resonance
imaging [MRI] findings)

- No distant metastases, based upon:

- CT scan or MRI of the pelvis within 120 days prior to registration

- Bone scan within 120 days prior to registration; if the bone scan is suspicious,
a plain x-ray and/or MRI must be obtained to rule out metastasis

- Karnofsky performance status (KPS) >= 70

- Ability to understand, and willingness to sign, the written informed consent

- Patient will have opted for SBRT among definitive treatment choices

Exclusion Criteria:

- Patients with any evidence of distant metastases

- Hormonal therapy (luteinizing hormone-releasing hormone [LHRH] agonist or oral
anti-androgen) exceeding 4 months prior to registration

- Prior cryosurgery, high intensity focused ultrasound (HIFU) or brachytherapy of the
prostate

- Prior pelvic radiotherapy

- History of Crohn’s disease or Ulcerative colitis