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Clinical Trials/NCT02290366
NCT02290366
Withdrawn
Not Applicable

Prospective Evaluation of Focal Brachytherapy Using Cesium-131 For Patients With Low Risk Prostate Cancer

Ronald M. Benoit, MD1 site in 1 countryNovember 2014
ConditionsProstate Cancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Prostate Cancer
Sponsor
Ronald M. Benoit, MD
Locations
1
Primary Endpoint
biochemical disease free survival
Status
Withdrawn
Last Updated
3 years ago

Overview

Brief Summary

The standard options for men with very low risk prostate cancer include active surveillance and the standard treatment options for low risk disease, i.e. radical prostatectomy, external beam radiotherapy, and whole gland prostate brachytherapy. The present study seeks to evaluate focal brachytherapy using the isotope Cesium 131 to treat patients with low risk prostate cancer. The goals of the study are to determine the biochemical disease free survival at five years in these patients, as well as to determine the acute and late urinary, bowel, and sexual toxicity associated with focal prostate brachytherapy using Cesium 131. Patients eligible for the study will be men with histologically confirmed adenocarcinoma of the prostate with clinical stage T1c-T2aN0M0, Gleason score ≤3+3=6, prostate specific antigen(PSA) <10 ng/ml or a PSA density ≤ 0.15 ng/cc, and ≤ 2 cores positive out of a minimum of 12 cores sampled. Additionally, patients must have a single, dominant index lesion on MRI. The study is a phase II study. Patients will be followed prospectively. Dosimetry will be evaluated post-procedure, and PSAs will be obtained every three months in year one and every six months from year two through year five. Urinary, bowel, and sexual morbidity will be assessed by patient survey prior to treatment , two weeks, after treatment, at three month intervals in year one and at six month intervals in years two through five.

Registry
clinicaltrials.gov
Start Date
November 2014
End Date
July 31, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Male

Investigators

Sponsor
Ronald M. Benoit, MD
Responsible Party
Sponsor Investigator
Principal Investigator

Ronald M. Benoit, MD

Associate Professor

University of Pittsburgh

Eligibility Criteria

Inclusion Criteria

  • Histologically confirmed adenocarcinoma of the prostate
  • Clinical stage T1c-T2aN0M0
  • Gleason score \<= 3+3=6
  • prostate specific antigen (PSA) \<10 ng/ml
  • \<= 2 cores positive out of a minimum of 12 cores sampled

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

biochemical disease free survival

Time Frame: five years

Study Sites (1)

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