Safety and Efficacy of 21 Gy for High Dose Rate (HDR) Prostate Brachytherapy

Inclusion Criteria:

- Histologically or cytologically confirmed diagnosis of early stage prostate cancer.

- Must be considered either low-risk (T1-T2a, Gleason ≤ 6, PSA < 10 ng/mL) or favorable
intermediate-risk (Gleason 3 +4 = 7, percentage of positive biopsy cores < 50%, no
more than one NCCN intermediate risk factor).

- Prior androgen deprivation therapy is allowed and may have been initiated up to 6
months prior to the date of the HDR implant. The complete duration of androgen
deprivation therapy can range from 4 months to 36 months provided it has been
initiated no more than 6 months prior to the date of the HDR implant.

- At least 18 years of age.

- ECOG performance status ≤ 2

- Able to understand and willing to sign an IRB approved written informed consent
document (or that of legally authorized representative, if applicable).

Exclusion Criteria:

- Prior radiation therapy to the prostate or lower pelvis encompassing the prostate.

- A history of other malignancy ≤ 5 years previous with the exception of basal cell or
squamous cell carcinoma of the skin which were treated with local resection only.

- Currently receiving any other investigational agents.

- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac
arrhythmia.

- Unable to undergo general, spinal or local anesthesia.

- Prior TURP