Efficacy of Prostate Seed Implantation for Local Control of Early Stage Prostate Cancer
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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 |
| 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 |
- 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) |
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 |
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
More Information
No publications provided
| Responsible Party: | William Demas, Study Principal Investigator, Summa Health System |
| ClinicalTrials.gov 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 Neoplasms, Male Urogenital Neoplasms Neoplasms by Site |
Neoplasms Genital Diseases, Male Prostatic Diseases |
ClinicalTrials.gov processed this record on May 23, 2013