Efficacy of Prostate Seed Implantation for Local Control of Early Stage Prostate Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
William Demas, Summa Health System
ClinicalTrials.gov Identifier:
NCT00773305
First received: October 15, 2008
Last updated: December 26, 2012
Last verified: December 2012

October 15, 2008
December 26, 2012
October 2008
November 2010   (final data collection date for primary outcome measure)
To determine the efficacy of prostate brachytherapy for local control of early stage prostate cancer at Summa Health System [ Time Frame: Pre-op through 4 follow-up visits ] [ Designated as safety issue: No ]
A retrospective chart review of PSA values on 85 patients from 2001-2008 with prostate cancer stage T1c-T2a NX MO, who were treated with permanent prostate brachytherapy using conventional transrectal ultrasound guided placement of Iodine-125 seeds delivering 145 Gy or 110 Gy, depending on whether mono or combination therapy with external beam radiotherapy (EBRT) was used. Those who had EBRT received 45 Gy prior to seed implants. Some patients also received hormonal therapy.
Not Provided
Complete list of historical versions of study NCT00773305 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Efficacy of Prostate Seed Implantation for Local Control of Early Stage Prostate Cancer
Chart Review of the Efficacy of Prostate Seed Implantation for Local Control of Early Stage Prostate Cancer

The primary goal of this project is to evaluate the efficacy of prostate seed implantation for the treatment of early stage prostate cancer for patients treated at Summa Health System/Akron City Hospital and Salem Community Hospital.

Charts of early stage prostate cancer patients receiving prostate seed implants with or without external beam radiotherapy and/or hormonal therapy will be reviewed and abstracted. The abstracted data will include pathology reports including Gleason score and T stage, PSA, treatment assignment and dosimetry parameters including dose and percent compliant with established criteria based on guidelines established by the American Brachytherapy Society.

A database will be developed for capture of the abstracted data. Outcomes will be determined based on PSA levels at 2 and 5 years after prostate seed implantation. The role of hormonal therapy with prostate seed implantation and outcomes will be evaluated. The outcomes will be compared to national statistics.

Observational
Observational Model: Ecologic or Community
Time Perspective: Retrospective
Not Provided
Not Provided
Probability Sample

Prostate seed implantation for the treatment of early stage prostate cancer

Prostate Cancer
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
October 2012
November 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Prostate seed implantation for the treatment of early stage prostate cancer
Male
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00773305
Prostate Seed Implantation
No
William Demas, Summa Health System
Summa Health System
Not Provided
Principal Investigator: William Demas, MD Summa Health System
Summa Health System
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP