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

Recruitment & Eligibility

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 with a sufficiently large defect that would compromise the integrity of the implant per clinician's assessment.

Study & Design

Arm && Interventions

Group	Intervention	Description
HDR brachytherapy - 23 Gy	HDR brachytherapy	-All patients will be treated with a single implant and single HDR fraction. Treatment will be delivered within a single 24-hour period measured from the beginning of the implant procedure. All patients will receive a dose of 23 Gy.
HDR brachytherapy - 21 Gy	HDR brachytherapy	-All patients will be treated with a single implant and single HDR fraction. Treatment will be delivered within a single 24-hour period measured from the beginning of the implant procedure. All patients will receive a dose of 21 Gy.
HDR brachytherapy - 25 Gy	HDR brachytherapy	-All patients will be treated with a single implant and single HDR fraction. Treatment will be delivered within a single 24-hour period measured from the beginning of the implant procedure. All patients will receive a dose of 25 Gy.

Primary Outcome Measures

Name	Time	Method
Biochemical control experienced by patients with prostate cancer treated with an HDR implant	Through 3 years after implant	-Response will be determined by PSA. The Phoenix definition will be used for determining biochemical failure: a rise of 2 ng/mL or more above the PSA nadir

Secondary Outcome Measures

Name	Time	Method
Rate of acute toxicity experienced by patients with prostate cancer treated with an HDR implant	From start of treatment through 90 days	-The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for all toxicity reporting.
Rate of late toxicity experienced by patients with prostate cancer treated with an HDR implant	From day 91 through 3 years after implant	-The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for all toxicity reporting.

Recruitment & Eligibility