Prostate Volume Changes Following Prostate Brachytherapy With Iodine-125 Seeds

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. Identifier: NCT00348465
Recruitment Status : Completed
First Posted : July 4, 2006
Last Update Posted : April 6, 2018
Information provided by (Responsible Party):
New York Methodist Hospital

Brief Summary:
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 or disease Intervention/treatment
Prostate Cancer Procedure: Brachytherapy with Iodine-125 seeds

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
Actual Enrollment : 29 participants
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.
Actual Study Start Date : May 2006
Actual Primary Completion Date : December 2007
Actual Study Completion Date : March 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Iodine

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Prostate Cancer patients

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

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 identifier (NCT number): NCT00348465

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

Responsible Party: New York Methodist Hospital Identifier: NCT00348465     History of Changes
Other Study ID Numbers: NYM-353
First Posted: July 4, 2006    Key Record Dates
Last Update Posted: April 6, 2018
Last Verified: May 2008

Keywords provided by New York Methodist Hospital:
Prostate volume

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