Prostate Volume Changes Following Prostate Brachytherapy With Iodine-125 Seeds

This study has been completed.

First Received: July 3, 2006 Last Updated: May 20, 2008 History of Changes

Sponsored by:	New York Methodist Hospital
Information provided by:	New York Methodist Hospital
ClinicalTrials.gov Identifier:	NCT00348465

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:	Cohort, 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:

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Cadexomer iodine Iodine

U.S. FDA Resources

Further study details as provided by New York Methodist Hospital:

Biospecimen Retention: None Retained

Biospecimen Description:

Enrollment:	29
Study Start Date:	May 2006
Study Completion Date:	March 2008

Intervention Details:

Brachytherapy of the prostate, and measurements of the prostate volume using CT scan and TURS

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

Keywords provided by New York Methodist Hospital:

Brachytherapy
Prostate volume

Study placed in the following topic categories:

Anti-Infective Agents
Anti-Infective Agents, Local
Prostatic Diseases
Genital Neoplasms, Male
Iodine

Trace Elements
Urogenital Neoplasms
Micronutrients
Genital Diseases, Male
Prostatic Neoplasms

Additional relevant MeSH terms:

Anti-Infective Agents
Genital Neoplasms, Male
Prostatic Diseases
Growth Substances
Physiological Effects of Drugs
Urogenital Neoplasms
Trace Elements
Genital Diseases, Male

Pharmacologic Actions
Anti-Infective Agents, Local
Neoplasms
Neoplasms by Site
Therapeutic Uses
Iodine
Micronutrients
Prostatic Neoplasms

ClinicalTrials.gov processed this record on September 11, 2009