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

This study has been completed.
University of Washington
Information provided by (Responsible Party):
Gregory Merrick, M.D., Schiffler Cancer Center Identifier:
First received: October 14, 2005
Last updated: November 16, 2015
Last verified: November 2015
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.

Condition Intervention Phase
Prostate Cancer
Procedure: External beam radiation
Procedure: Pd-103
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Low Dose Supplemental External Radiation With PD-103 Versus PD-103 Alone For Prostate Cancer

Resource links provided by NLM:

Further study details as provided by Schiffler Cancer Center:

Primary Outcome Measures:
  • 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.

  • Post treatment biopsies in those with persistently elevated [ Time Frame: as needed ]
    Post treatment biopsies in those with persistently elevated

  • PSA which is suggestive of residual tumor. [ Time Frame: as needed ]
    PSA which is suggestive of residual tumor.

Enrollment: 396
Study Start Date: January 2005
Study Completion Date: November 2015
Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Pd-103 with 20Gy External Beam
Pd-103 with 20Gy External Beam
Procedure: External beam radiation
Active Comparator: Pd-103 alone
Pd-103 alone
Procedure: Pd-103

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.


Ages Eligible for Study:   40 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00241384

United States, Washington
Veterans Administration Puget Sound Health Care System
Seattle, Washington, United States, 98108-1597
United States, West Virginia
Schiffler Cancer Center
Wheeling, West Virginia, United States, 26003
Sponsors and Collaborators
Schiffler Cancer Center
University of Washington
Principal Investigator: Gregory S Merrick, MD Schiffler Cancer Center, Wheeling, WV
Study Chair: Kent E Wallner, MD University of Washington VA Center
  More Information

Blasko JC, Ragde H, Schumacher D. Transperineal percutaneous iodine-125 implantatio for prostatic carcinoma using transrectal ultrasound and template guidance. Endo/Hypertherm 1987;3:131-39.
Wallner K, Merrick G, Butler W, Sheretz T, Sutlief S, Cavanagh W, et al. 20 Gy versus 44 Gy supplemental beam radiation combined with Pd-103 prostate brachytherapy: early results from a prospective randomized multicenter trial (submitted)2004.

Responsible Party: Gregory Merrick, M.D., Medical Director, Schiffler Cancer Center Identifier: NCT00241384     History of Changes
Other Study ID Numbers: 04-8-10
Study First Received: October 14, 2005
Last Updated: November 16, 2015

Keywords provided by Schiffler Cancer Center:
Prostatic Cancer
Prostatic neoplasm
Radiation therapy

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases processed this record on April 27, 2017