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

• Sponsor: Ronald M. Benoit, MD (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT02290366
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 87
• Patients Per Site Per Month: 1.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer	Radiation: Focal prostate brachytherapy with Cesium-131	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Brachytherapy, using Cesium 131Brachytherapy, using Cesium 131
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Prospective Evaluation of Focal Brachytherapy Using Cesium-131 For Patients With Low Risk Prostate Cancer
• Actual Study Start Date: Nov 1, 2014
• Anticipated Primary Completion Date: Feb 1, 2022
• Anticipated Study Completion Date: Feb 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Focal Therapy	Radiation: Focal prostate brachytherapy with Cesium-131

Outcome Measures

Primary Outcome Measures

1. biochemical disease free survival [five years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UPMC Mercy	Pittsburgh	Pennsylvania	United States	15219

Sponsors and Collaborators

• Ronald M. Benoit, MD

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ronald M. Benoit, MD, Associate Professor, University of Pittsburgh
• ClinicalTrials.gov Identifier: NCT02290366
• Other Study ID Numbers: PRO14020322
• First Posted: Nov 14, 2014
• Last Update Posted: Feb 15, 2021
• Last Verified: Feb 1, 2021

• Additional relevant MeSH terms: Prostatic Neoplasms

Study Results

No Results Posted as of Feb 15, 2021