Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

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

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.

Prostate Cancer

Study Type: Observational
Study Design: Observational Model: Ecologic or Community
Time Perspective: Retrospective
Official Title: Chart Review of the Efficacy of Prostate Seed Implantation for Local Control of Early Stage Prostate Cancer

Resource links provided by NLM:

Further study details as provided by Summa Health System:

Primary Outcome Measures:
  • 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.

Enrollment: 200
Study Start Date: October 2008
Study Completion Date: October 2012
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Detailed Description:

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.


Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Prostate seed implantation for the treatment of early stage prostate cancer


Inclusion Criteria:

  • Prostate seed implantation for the treatment of early stage prostate cancer
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00773305

Sponsors and Collaborators
Summa Health System
Principal Investigator: William Demas, MD Summa Health System
  More Information

No publications provided

Responsible Party: William Demas, Study Principal Investigator, Summa Health System Identifier: NCT00773305     History of Changes
Other Study ID Numbers: Prostate Seed Implantation
Study First Received: October 15, 2008
Last Updated: December 26, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Summa Health System:
seed implantation

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms processed this record on February 25, 2015