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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by Schiffler Cancer Center
Sponsor:
Collaborators:
Theragenics
University of Washington
Information provided by (Responsible Party):
Gregory Merrick, M.D., Schiffler Cancer Center
ClinicalTrials.gov Identifier:
NCT00241384
First received: October 14, 2005
Last updated: May 29, 2013
Last verified: May 2013
  Purpose

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
Endpoint Classification: Efficacy Study
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 ] [ Designated as safety issue: No ]
    Serial PSA : 6, 12, 18 and 24 months and then yearly.

  • Post treatment biopsies in those with persistently elevated [ Time Frame: as needed ] [ Designated as safety issue: No ]
    Post treatment biopsies in those with persistently elevated

  • PSA which is suggestive of residual tumor. [ Time Frame: as needed ] [ Designated as safety issue: No ]
    PSA which is suggestive of residual tumor.


Estimated Enrollment: 300
Study Start Date: January 2005
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (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.

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00241384

Contacts
Contact: Gregory S Merrick, MD 304-243-3490 gmerrick@urologicresearchinstitute.org
Contact: Kent E Wallner, MD 206-768-5356 Kent.Wallner@med.va.gov

Locations
United States, Washington
Veterans Administration Puget Sound Health Care System Recruiting
Seattle, Washington, United States, 98108-1597
Contact: Kent E Wallner, MD    206-768-5356    Kent.Wallner@med.va.gov   
United States, West Virginia
Schiffler Cancer Center Recruiting
Wheeling, West Virginia, United States, 26003
Contact: Gregory S Merrick, MD    304-243-3490    gmerrick@urologicresearchinstitute.org   
Contact: Robin Stipetich, RN, OCN    304-243-3490      
Principal Investigator: Gregory S Merrick, MD         
Sponsors and Collaborators
Schiffler Cancer Center
Theragenics
University of Washington
Investigators
Principal Investigator: Gregory S Merrick, MD Schiffler Cancer Center, Wheeling, WV
Study Chair: Kent E Wallner, MD University of Washington VA Center
  More Information

Publications:
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.

Responsible Party: Gregory Merrick, M.D., Medical Director, Schiffler Cancer Center
ClinicalTrials.gov Identifier: NCT00241384     History of Changes
Other Study ID Numbers: 04-8-10
Study First Received: October 14, 2005
Last Updated: May 29, 2013
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on September 18, 2014