Efficacy of Prostate Seed Implantation for Local Control of Early Stage Prostate Cancer
|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|
- 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.
|Study Start Date:||October 2008|
|Study Completion Date:||October 2012|
|Primary Completion Date:||November 2010 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00773305
|Principal Investigator:||William Demas, MD||Summa Health System|