NCT00773305

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2008

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

October 15, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 16, 2008

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

December 28, 2012

Status Verified

December 1, 2012

Enrollment Period

2.1 years

First QC Date

October 15, 2008

Last Update Submit

December 26, 2012

Conditions

Prostate Cancer

Keywords

seed implantation

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Age18 Years - 80 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Prostate seed implantation for the treatment of early stage prostate cancer

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • William Demas, MD

    Summa Health System

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Study Principal Investigator

Study Record Dates

First Submitted

October 15, 2008

First Posted

October 16, 2008

Study Start

October 1, 2008

Primary Completion

November 1, 2010

Study Completion

October 1, 2012

Last Updated

December 28, 2012

Record last verified: 2012-12