Assessing the Potential for Reduced Toxicity Using Focal Brachytherapy in Early Stage, Low Volume Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Prostate Biopsy, Focal Brachytherapy , Assessment of QOL
Intervention description: A re-staging transrectal or transperineal ultrasound-guided prostate biopsy as currently performed at participating institutions. Focal brachytherapy will be performed at 8 weeks following the transrectal or transperineal biopsy or sooner if the patient has recovered from the repeat biopsy and the treating physician determines it is safe to proceed with treatment. The regions will be targeted with the prescription dose and receive 144 Gy of Iodine-125 (I-125). The quality-of-life assessment will focus on erectile function, urinary function, bowel function, and general health related quality of life. The patients will complete this assessment at baseline and then approximately 3 ± 1 months, 6 ± 1 months, 12 ± 2 months, 18 ± 2 months, and 24 ± 2 months after treatment.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 3.0
Sex: Male
Minimum age: 21 Years
Healthy volunteers: No
Keywords: Focal Brachytherapy; Endorectal coil MRI; Quality of Life; 11-056

Summary:

      The purpose of this study is to see what side effects a type of radiation treatment called
      focal brachytherapy has in treating early stage prostate cancer. The study is also looking at
      how useful focal brachytherapy will be in treating prostate cancer. Additionally, the
      investigators would like to see how this type of treatment impacts quality of life.
    

Eligibility criteria:

        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:

          -  Medically unfit for anesthesia

          -  Evidence or suspicion of extracapsular extension on MRI

          -  IPSS score > 18

          -  Unable to receive MRI

          -  Prior radiotherapy for the current disease