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

NCT02290366 | Withdrawn

• 1 other identifier: PRO14020322
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• biochemical disease free survival

  five years

Study Arms (1)

Focal Therapy

EXPERIMENTAL

Radiation: Focal prostate brachytherapy with Cesium-131

Interventions

Focal prostate brachytherapy with Cesium-131 RADIATION

Focal Therapy

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Ronald M. Benoit, MD: lead

Study Sites (1)

UPMC Mercy

Pittsburgh, Pennsylvania, 15219, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Cesium-131

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Model Details: Brachytherapy, using Cesium 131

Study Record Dates

• First Submitted: November 5, 2014
• First Posted: November 14, 2014
• Study Start: November 1, 2014
• Primary Completion: July 31, 2022
• Study Completion: July 31, 2022
• Last Updated: August 29, 2022

Record last verified: 2022-08

Locations

US (1)