Prostate Volume Changes Following Prostate Brachytherapy With Iodine-125 Seeds

September 16, 2020 updated by: Hani Ashamalla, MD, New York Presbyterian Brooklyn Methodist Hospital

An Observational Study to Evaluate the Changes in Prostate Volume Over Time With The Use of Transrectal Ultrasound and Computed Tomography Following Permanent Prostate Brachytherapy With Iodine-125 Seeds.

The size of the prostate changes due to insertion of the radioactive seeds. We will measure the prostate size, before and after the procedure.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The prostate size will be measured using the TRUS and CT scan on days -1, 0, 1, 9, 30, and 60 days after the brachytherapy procedure.

Study Type

Observational

Enrollment (Actual)

29

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

Prostate Cancer patients

Description

Inclusion Criteria:

  • Pathologically confirmed diagnosis of prostate cancer
  • T1-3 disease
  • PSA <20 ng/ml
  • Patient must sign a study-specific informed consent prior to enrollment.

Exclusion Criteria:

  • Patients ineligible to brachytherapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

New York Presbyterian Brooklyn Methodist Hospital

Investigators

  • Study Chair: Hani Ashamalla, MD, FCCP, New York Presbyterian Brooklyn Methodist Hospital
  • Principal Investigator: Ewa Bieniek, MD, NY Methodist Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 1, 2006

Primary Completion (ACTUAL)

December 1, 2007

Study Completion (ACTUAL)

March 1, 2008

Study Registration Dates

First Submitted

July 3, 2006

First Submitted That Met QC Criteria

July 3, 2006

First Posted (ESTIMATE)

July 4, 2006

Study Record Updates

Last Update Posted (ACTUAL)

September 18, 2020

Last Update Submitted That Met QC Criteria

September 16, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NYM-353

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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