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.
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.