Phase II Study of Hypofractionated Stereotactic Body Radiation Therapy as a Boost to the Prostate for Treatment of Localized, Non-Metastatic, High Risk Prostate Cancer
Inclusion Criteria:
1. Histologically proven adenocarcinoma of the prostate a. Gleason score (2-10) b.
Biopsy within six months of date of registration
2. Clinical stage (American Joint Committee on Cancer [AJCC] 7th Edition) a. T-stage
determined by physical exam i. MRI findings (e.g. extracapsular extension) should not
influence T-staging, but should be noted for later analysis b. N-stage determined
using abdominopelvic CT scan c. M-stage determined by physical exam, CT and/or MRI,
and bone scan
3. Patients must belong to one of the following risk groups: a. Very High risk: cT3 and
Gleason 8-10 and PSA less than 150 b. High risk: cT1-T2 and Gleason 8-10 and PSA less
than 150 c. Moderate high risk: cT3 and Gleason 7 and any PSA d. Intermediate to high
risk (a) cT3 and Gleason 6 and PSA at least 30 e. Intermediate to high risk (b):
cT1-T2 and Gleason 7 and PSA at least 30
4. Patient is planned to undergo standard androgen deprivation therapy and initial
Intensity Modulated Radiation Therapy (IMRT) to the prostate and at-risk lymph nodes.
5. Prostate volume greater than 20 cc and less than 100 cc
6. Eastern Cooperative Oncology Group (ECOG) performance status 0-1
7. Patient has agreed to complete questionnaires
8. Signed Institutional Review Board (IRB) approved informed consent
Exclusion Criteria:
1. No prior prostate surgery or prostate cancer treatment
2. No prior radiotherapy to the pelvis
3. No implanted hardware or other material that would prohibit appropriate treatment
planning or treatment delivery
4. No chemotherapy for a malignancy in the last 5 years.
5. No history of an invasive malignancy (other than basal or squamous skin cancers) in
the last 5 years.
6. No history of a horseshoe kidney
7. No diagnosis of inflammatory bowel disease
8. No heart pacemaker, No metallic foreign body (metal sliver) in the eye, No aneurysm
clip in the brain
9. Must be able to tolerate the confinement of an MRI procedure