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

NCT ID: NCT02290366

Last Updated: 2022-08-29

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-30
• Study Completion Date: 2022-07-31

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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Focal Therapy

Group Type: EXPERIMENTAL

Focal prostate brachytherapy with Cesium-131

Intervention Type: RADIATION

Interventions

Focal prostate brachytherapy with Cesium-131

Intervention Type: RADIATION

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

• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Ronald M. Benoit, MD

OTHER

Sponsor Role: lead

Responsible Party

Ronald M. Benoit, MD

Associate Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

UPMC Mercy

Pittsburgh, Pennsylvania, United States

Countries

United States

Other Identifiers

PRO14020322

Identifier Type: -

Identifier Source: org_study_id