Assessing the Potential for Reduced Toxicity Using Focal Brachytherapy in Early Stage, Low Volume Prostate Cancer

Recruitment & Eligibility

Inclusion Criteria

Men ≥ 21 years of age with a life expectancy estimated to be > 10-years.
Diagnosis of adenocarcinoma of the prostate confirmed by MSKCC or participating site pathology review.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Prostate cancer clinical stage T1c-T2a
PSA < 10ng/mL (this will be the PSA level prompting the prostate biopsy)
MRI evidence of one-sided disease performed within 3 months of registration
Prostate size <60 cc at time of treatment- if the prostate is larger, hormonal therapy is allowed to achieve the required size Screening biopsy parameters:
Minimum of 10 biopsy cores
Gleason grade 7 in two cores or less, with no primary Gleason grade 4 or 5 in any cores
Unilateral cancer (only right-sided or left-sided, not bilateral)
No more than 50 % cancer in any one biopsy core
No more than 25 % of cores containing cancer
Repeat transrectal or transperineal prostate biopsy that must meet the following parameters:
Minimum of 12 biopsy cores
Unilateral cancer (only right-sided or left-sided, not bilateral)
Gleason grade 7 in two cores or less, with no primary Gleason grade 4 or 5 in any cores
No more than 50 % cancer in any one biopsy core
No more than 25 % of cores containing cancer

Subject

Exclusion Criteria

Study & Design

Arm && Interventions

Group	Intervention	Description
Prostate Biopsy, Focal Brachytherapy , Assessment of QOL	Prostate Biopsy, Focal Brachytherapy , Assessment of QOL	This is a non-randomized, Phase II study examining the tolerance profile (primary endpoint) as well as the secondary endpoints of QOL changes, efficacy and the correlation of post-treatment MRI findings with post-treatment biopsy outcomes in men with early stage low volume prostate cancer treated with focal brachytherapy.

Primary Outcome Measures

Name	Time	Method
To Assess the Late Toxicity Outcomes	6 months to 2 years	focal brachytherapy in patients with low risk prostate cancer This study will utilize the toxicity grading scale Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0

Secondary Outcome Measures

Name	Time	Method
To Correlate Post-treatment MRI Findings With Post-treatment Biopsy Outcomes	2 years	Post-treatment MRI outcome is defined as a 3-level categorical variable: positive, negative and undetermined. Post-treatment biopsy outcome is defined as a binary variable: positive and negative. We will examine the correlation between the 12-month MRI and 12-month biopsy, and between the 24-month MRI and 24-month biopsy. The correlation will be assessed by a Fisher exact test.
To Evaluate the Local Tumor Control After Focal Brachytherapy	12 and 24 months	as measured by the ability to obtain all negative biopsy cores 12 and 24 months after completion of therapy in the hemi-gland of where the focal therapy was administered. "All negative" means no prostate cancer;
To Evaluate the Change From Baseline in QOL Indicators	baseline and then approximately 3 ± 1 months, 6 ± 1 months, 12 ± 2 months, 18 ± 2 months, and 24 ± 2 months after treatment	Following focal brachytherapy in patients with early stage low volume localized prostate cancer. The scales to measure these domains were derived from the previously validated MSKCC Prostate-Health Related Quality of Life Questionnaire (PHRQOLQ

Recruitment & Eligibility