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

Prostate Cancer Clinical Trial

Official title:

Chart Review of the Efficacy of Prostate Seed Implantation for Local Control of Early Stage Prostate Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00773305
• Other study ID #: Prostate Seed Implantation
• Status: Completed
• Phase: N/A
• First received: October 15, 2008
• Last updated: December 26, 2012
• Start date: October 2008
• Est. completion date: October 2012

Study information

• Verified date: December 2012
• Source: Summa Health System
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: October 2012
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Prostate seed implantation for the treatment of early stage prostate cancer

Study Design

Observational Model: Ecologic or Community, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Summa Health System

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the efficacy of prostate brachytherapy for local control of early stage prostate cancer at Summa Health System	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.	Pre-op through 4 follow-up visits	No