Stereotactic Body Radiation Therapy in Treating Patients With High-Risk Prostate Cancer Undergoing Surgery

PRIMARY OBJECTIVES:

I. To assess feasibility of pre-operative stereotactic body radiotherapy (SBRT) in prostate
cancer patients at high risk for recurrence after prostatectomy.

SECONDARY OBJECTIVES:

I. To assess safety and acute toxicity of SBRT followed by prostatectomy. This will be based
on Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 and patient reported
quality of life (Expanded Prostate Cancer Index Composite [EPIC] and International Prostate
Symptom Score [IPSS] questionnaires).

II. Correlative biomarker and molecular analyses using the primary tumor specimen and serial
blood draws before and after treatment.

OUTLINE:

Patients undergo 3 fractions of SBRT over 1-2 weeks, 2-4 weeks prior to radical
prostatectomy.

After completion of the study treatment, patients are followed up every 3 months for 1 year.

Inclusion Criteria:

- Histologically confirmed primary non-metastatic adenocarcinoma of the prostate

- Patient desires and is medically fit to undergo prostatectomy

- Karnofsky performance status (KPS) >= 70

- Patients on androgen deprivation therapy (ADT) are allowed

- For confirmation of high risk local failure status, patients will have any one of the
following:

- Computed tomography (CT) or magnetic resonance imaging (MRI) demonstrating
seminal vesicle invasion (SVI) or extraprostatic extension (EPE) within 1 year of
enrollment into the study

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

- Gleason score 7-10 (Gleason 7 must be 4+3), presence of any Gleason 5 (even if a
tertiary score) as determined at diagnostic biopsy

- Gleason score 7 and > 50% of biopsy cores positive for prostate cancer

- Clinical stage >= T3 (staging by imaging acceptable)

- An image-guided biopsy (via Artemis Ultrasound with MRI co-registration) is encouraged
but not required if not performed as standard of care biopsy

Exclusion Criteria:

- Distant metastases, based upon:

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

- 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 prior to
registration

- Patient is unable or unwilling to sign consent

- Patient is considered low-risk and would not have received adjuvant radiation therapy
(RT) outside of this study