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Prostate Volume Changes Following Prostate Brachytherapy With Iodine-125 Seeds

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00348465
First Posted: July 4, 2006
Last Update Posted: May 22, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
New York Methodist Hospital
  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:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes 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
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): 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

Responsible Party: New York Methodist Hospital
ClinicalTrials.gov Identifier: NCT00348465     History of Changes
Other Study ID Numbers: NYM-353
First Submitted: July 3, 2006
First Posted: July 4, 2006
Last Update Posted: May 22, 2008
Last Verified: May 2008

Keywords provided by New York Methodist Hospital:
Brachytherapy
Prostate volume

Additional relevant MeSH terms:
Iodine
Anti-Infective Agents, Local
Anti-Infective Agents
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs