Dosimetric and Morbidity Outcomes of Cs-131 Brachytherapy in Combination With External Beam Radiation Therapy in Subjects With Intermediate to High Risk Adenocarcinoma of the Prostate: An Observational Study

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