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Prostate Volume Changes Following Prostate Brachytherapy With Iodine-125 Seeds

This study has been completed.
Sponsor:
Information provided by:
New York Methodist Hospital
ClinicalTrials.gov Identifier:
NCT00348465
First received: July 3, 2006
Last updated: May 20, 2008
Last verified: May 2008
History of Changes
  Purpose

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


Condition Intervention
Prostate Cancer
 Procedure: Brachytherapy with Iodine-125 seeds

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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.

Resource links provided by NLM:

Drug Information available for: Iodine Iodide
U.S. FDA Resources

Further study details as provided by New York Methodist Hospital:

Enrollment: 29
Study Start Date: May 2006
Study Completion Date: March 2008
Intervention Details:
    Procedure: Brachytherapy with Iodine-125 seeds
    Brachytherapy of the prostate, and measurements of the prostate volume using CT scan and TURS
    Other Name: Prostate Volume over time
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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Prostate Cancer patients

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00348465

Sponsors and Collaborators
New York Methodist Hospital
Investigators
Study Chair: Hani Ashamalla, MD, FCCP New York Methodist Hospital
Principal Investigator: Ewa Bieniek, MD NY Methodist Hospital
  More Information

No publications provided

Responsible Party: New York Methodist Hospital
ClinicalTrials.gov Identifier: NCT00348465     History of Changes
Other Study ID Numbers: NYM-353
Study First Received: July 3, 2006
Last Updated: May 20, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by New York Methodist Hospital:
Brachytherapy
Prostate volume

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Iodine
Cadexomer iodine
 Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 18, 2013