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

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ClinicalTrials.gov Identifier: NCT02290366
Recruitment Status : Recruiting
First Posted : November 14, 2014
Last Update Posted : October 9, 2018
Sponsor:
Information provided by (Responsible Party):
Ronald M. Benoit, MD, University of Pittsburgh

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 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Evaluation of Focal Brachytherapy Using Cesium-131 For Patients With Low Risk Prostate Cancer
Study Start Date : November 2014
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

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



Primary Outcome Measures :
  1. biochemical disease free survival [ Time Frame: five years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02290366


Contacts
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Contact: Kelley Colopietro 412-232-9012 colopietrokj@upmc.edu

Locations
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United States, Pennsylvania
UPMC Mercy Recruiting
Pittsburgh, Pennsylvania, United States, 15219
Contact: Kelley J Colopietro    412-232-9012    colopietrokj@upmc.edu   
Principal Investigator: Ronald Benoit, MD         
Sponsors and Collaborators
Ronald M. Benoit, MD

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Responsible Party: Ronald M. Benoit, MD, Associate Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT02290366     History of Changes
Other Study ID Numbers: PRO14020322
First Posted: November 14, 2014    Key Record Dates
Last Update Posted: October 9, 2018
Last Verified: October 2018

Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases