Neoadjuvant Stereotactic Body Radiotherapy Prior to Radical Prostatectomy for High Risk Prostate Cancer

Inclusion Criteria:

- Subjects must have biopsy-confirmed adenocarcinoma of the prostate.

- Subjects must have a negative bone scan.

- Subjects must have one of the following risk factors:

- PSA ≥20 and/or

- Gleason score ≥8 and/or

- Clinical or radiographic stage ≥T3a per AJCC (American Joint Committee on Cancer) 7th
Edition Staging Manual and/or

- Radiographic pelvic lymph node positive disease and/or

- At least two out of four of the following: PSA (Prostate Specific Antigen) 10-19.9, GS
(Gleason Score) = 3+4, clinical stage = T2b/T2c, ≥50% positive biopsy cores.

- Subjects must freely sign informed consent to enroll in the study.

- Subjects must be medically fit to undergo surgery determined by the PI.

- Age ≥ 18

- KPS Karnofsky Performance Status (performance status is an attempt to quantify cancer
patients' general well-being and activities of daily life, scores range from 0 to 100
where 100 represents perfect health and 0 represents death): ≥70.

- No prior invasive malignancy in the past 3-years, except non-melanomatous skin cancer
unless disease free for a minimum of 2 years. Carcinoma in-situ of the bladder or head
and neck region is permissible.

- Subjects must not have had prior pelvic radiation therapy,

- Subjects must not have had prior androgen deprivation therapy in the past 6 months.

Exclusion Criteria:

- Metastatic disease as demonstrated by bone scan, CT scan or MRI (Magnetic Resonance
Imaging) of the pelvis, or chest x-ray.

- Declared high-risk for anesthesia by attending anesthesiologist, cardiologist, or
other physician.

- History of prior pelvic radiation therapy.

- History of androgen deprivation therapy within the past 6 months.