Observation of Outcomes and Side Effects of Cesium-131 in Combination With External Beam Radiation for the Treatment of Intermediate to High Risk Prostate Cancer

Inclusion Criteria:

Histologically confirmed adenocarcinoma of the prostate
Clinical stage T1c - T2c (AJCC 6th Edition), NX/N0, M0
Karnofsky Performance Score of 90 to 100
Greater than or equal to 18 years of age
Prostate volumes by TRUS ≤ 60 cc
I-PSS score < 15 (alpha blockers allowed)
Signed study-specific informed consent form prior to study entry

Intermediate Risk prostate cancer as determined by the following:

Gleason sum of 7; PSA less than 10.1 ng/ml; Stage T2a or less
Gleason sum 6 or less; PSA >10.0 and < 20.1ng/ml; Stage T2a or less
Gleason sum 6 or less; PSA < 10.1; Stage T2b

High risk prostate cancer as determined by the following:

Any Gleason Sum; PSA greater than 20 ng/ml; Stage T2c or less
Gleason Sum > 7; Any PSA; Stage T2c or less
Any Gleason Sum; Any PSA; Stage T2c
Any two or three intermediate risk factor

Exclusion Criteria:

Lymph node involvement (N1)
Evidence of distant metastases (M1)

Any hormonal blockade or therapy that:

Has persisted for more than 6 months by time of protocol screening; OR
Is ongoing within 3 months of study enrollment
Radical surgery for carcinoma of the prostate
Prior pelvic radiation
Previous or concurrent cancers other than basal, in situ, or squamous cell skin cancers unless disease-free for ≥ 5 years
Major medical or psychiatric illness, which in the investigator's opinion, would prevent completion of treatment and would interfere with follow-up
Hip prosthesis
Inability or refusal to provide informed consent