Low Dose Supplemental External Radiation With Pd-103 Versus Pd-103 Alone for Prostate Cancer

November 16, 2015 updated by: Gregory Merrick, M.D., Schiffler Cancer Center

Low Dose Supplemental External Radiation With PD-103 Versus PD-103 Alone For Prostate Cancer

The primary purpose of this study is to evaluate two treatment regimens for prostate cancer, prostate implant with 20 Gy of external beam radiation therapy versus prostate implant with 0 Gy of external beam radiation therapy. Patients diagnosed with intermediate risk prostate cancer between the ages of 40 and 80 who have chosen brachytherapy with or without external beam radiation therapy as their intended treatment will be eligible and will be offered participation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Approximately 250,000 men are currently diagnosed with prostatic cancer in the United States each year. Of those, 70% have stage T1 or T2 disease (apparently limited to the prostate gland). Clinically localized prostate cancer is a spectrum of disease, ranging from good prognosis to poor prognosis. Patients with a PSA above 10 ng/ml or Gleason score of 7 to 10 are referred to as intermediate risk, with approximately an 80% chance of cure.

Implantation of radioactive sources directly into the prostate (brachytherapy) delivers a high, localized radiation dose while sparing most the of the bladder and rectum. Brachytherapy is well established for other tumor sites, and has become a standard treatment for prostate cancer.

Establishing that a good quality implant alone is as effective as implant plus beam radiation will allow us to routinely drop the use of beam radiation, a change in policy that will decrease the risk of some complications, will be more convenient for patients, and will lower treatment costs.

Study Type

Interventional

Enrollment (Actual)

396

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98108-1597
        • Veterans Administration Puget Sound Health Care System
    • West Virginia
      • Wheeling, West Virginia, United States, 26003
        • Schiffler Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Patients with previously untreated prostatic cancer.
  • Must have PSA 10-20 ng/ml, Gleason 7 to 9

Exclusion Criteria:

  • Patients with proven regional lymph node involvement will be excluded.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Pd-103 with 20Gy External Beam
Procedure: External beam radiation
Active Comparator: Pd-103 alone
Procedure: Pd-103

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serial PSA : 6, 12, 18 and 24 months and then yearly.
Time Frame: 6, 12, 18 and 24 months and then yearly
Serial PSA : 6, 12, 18 and 24 months and then yearly.
6, 12, 18 and 24 months and then yearly
Post treatment biopsies in those with persistently elevated
Time Frame: as needed
Post treatment biopsies in those with persistently elevated
as needed
PSA which is suggestive of residual tumor.
Time Frame: as needed
PSA which is suggestive of residual tumor.
as needed

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Schiffler Cancer Center

Collaborators

University of Washington
Theragenics

Investigators

  • Principal Investigator: Gregory S Merrick, MD, Schiffler Cancer Center, Wheeling, WV
  • Study Chair: Kent E Wallner, MD, University of Washington VA Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2005

Primary Completion (Actual)

November 1, 2015

Study Completion (Actual)

November 1, 2015

Study Registration Dates

First Submitted

October 14, 2005

First Submitted That Met QC Criteria

October 14, 2005

First Posted (Estimate)

October 18, 2005

Study Record Updates

Last Update Posted (Estimate)

November 17, 2015

Last Update Submitted That Met QC Criteria

November 16, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 04-8-10

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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