Phase II Study Assessing the Potential for Reduced Toxicity Using Focal Brachytherapy Early Stage, Low Volume in Prostate Cancer
Trial Snapshot
- Phase
- Phase 2
- Status
- Terminated
- Enrollment
- 3
- Locations
- 3
- Primary Endpoint
- To Assess the Late Toxicity Outcomes
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 21 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
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
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
Arms & Interventions
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.
Intervention: Prostate Biopsy, Focal Brachytherapy , Assessment of QOL (Other)
Outcomes
Primary Outcomes
To Assess the Late Toxicity Outcomes
Time Frame: 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 Outcomes
- To Correlate Post-treatment MRI Findings With Post-treatment Biopsy Outcomes(2 years)
- To Evaluate the Local Tumor Control After Focal Brachytherapy(12 and 24 months)
- 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)