Safety and Efficacy of 21 Gy, 23 Gy and 25 Gy for High Dose Rate (HDR) Prostate Brachytherapy

Prior treatment

• Prior radiation therapy to the prostate or lower pelvis encompassing the prostate.
• Currently receiving any other investigational agents.
• Prior TURP with a sufficiently large defect that would compromise the integrity of the implant per clinician's assessment.

Other illness

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

Age

• 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.

Other

• Unable to undergo general, spinal or local anesthesia.

• 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).