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

Not Applicable

Withdrawn

• Conditions: Prostate Cancer
• Interventions: Radiation: Focal prostate brachytherapy with Cesium-131

• Registration Number: NCT02290366
• Lead Sponsor: Ronald M. Benoit, MD

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-11
• Study First Submitted: 2014-11-05
• Study First Submitted QC: 2014-11-10
• Study First Posted: 2014-11-14
• Primary Completion: 2022-07-31
• Study Completion: 2022-07-31
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-23
• Last Update Posted: 2022-08-29

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Male
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Focal Therapy	Focal prostate brachytherapy with Cesium-131	-

Primary Outcome Measures

Name	Time	Method
biochemical disease free survival	five years

Trial Locations

Locations (1)

UPMC Mercy; 🇺🇸 Pittsburgh, Pennsylvania, United States