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

Completed

• Conditions: Prostate Cancer

• Registration Number: NCT00773305
• Lead Sponsor: Summa Health System

Brief 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.

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.

Study Timeline

• Study Start: 2008-10
• Study First Submitted: 2008-10-15
• Study First Submitted QC: 2008-10-15
• Study First Posted: 2008-10-16
• Primary Completion: 2010-11
• Study Completion: 2012-10
• Status Verified: 2012-12
• Last Update Submitted: 2012-12-26
• Last Update Posted: 2012-12-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 200

Inclusion Criteria

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

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine the efficacy of prostate brachytherapy for local control of early stage prostate cancer at Summa Health System	Pre-op through 4 follow-up visits	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.