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

Memorial Sloan Kettering Cancer Center3 sites in 1 country3 target enrollmentMay 2011

ConditionsProstate Cancer

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Prostate Cancer
Sponsor: Memorial Sloan Kettering Cancer Center
Enrollment: 3
Locations: 3
Primary Endpoint: To Assess the Late Toxicity Outcomes
Status: Terminated
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

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.

Registry

clinicaltrials.gov

Start Date

May 2011

End Date

October 6, 2017

Last Updated

7 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Male

Investigators

Sponsor

Memorial Sloan Kettering Cancer Center

Responsible Party

Sponsor

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)

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

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)