Chart Review of the Efficacy of Prostate Seed Implantation for Local Control of Early Stage Prostate Cancer - Full Text View

Sponsored by:	Summa Health System
Information provided by:	Summa Health System
ClinicalTrials.gov Identifier:	NCT00773305

Purpose

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.

Condition
Prostate Cancer

MedlinePlus related topics: Cancer Prostate Cancer

U.S. FDA Resources

Study Type:	Observational
Study Design:	Ecologic or Community, Retrospective

Further study details as provided by Summa Health System:

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	200
Study Start Date:	October 2008
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2008 (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.

Eligibility

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

Criteria

Inclusion Criteria:

Prostate seed implantation for the treatment of early stage prostate cancer

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00773305

Sponsors and Collaborators

Summa Health System

Investigators

Principal Investigator:

William Demas, MD

Summa Health System

More Information

Responsible Party:	Summa Health System ( William F. Demas, MD )
Study ID Numbers:	Prostate Seed Implantation
Study First Received:	October 15, 2008
Last Updated:	October 15, 2008
ClinicalTrials.gov Identifier:	NCT00773305
Health Authority:	United States: Institutional Review Board

Keywords provided by Summa Health System:

prostate seed implantation for the treatment of early stage prostate cancer

Study placed in the following topic categories:

Prostatic Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 14, 2009