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I-125 Versus Pd-103 for Medium Risk Prostate Cancer

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ClinicalTrials.gov Identifier: NCT00486499
Recruitment Status : Unknown
Verified June 2007 by VA Puget Sound Health Care System.
Recruitment status was:  Recruiting
First Posted : June 14, 2007
Last Update Posted : June 14, 2007
Sponsor:
Collaborators:
Dr. Gregory Merrick
Theragenics Corporation
Information provided by:
VA Puget Sound Health Care System

Brief Summary:

hypothesis: the shorter half-life of Pd-103 versus I-125, will increase the rate of tumor eradication.

A total of 660 patients with AJC clinical stage T1c-T2a prostatic carcinoma (Gleason grade 7 to 9 and/or PSA 10–20 ng/ml) will be randomized to implantation with I-125 (144 Gy) versus Pd-103 (124 Gy).


Condition or disease Intervention/treatment Phase
Prostate Cancer Procedure: I-125 versus Pd-103 radioactive seed insertion Phase 3

Detailed Description:

Objective: The objective of this study is test the hypothesis that the shorter half-life of Pd-103 versus I-125, will increase the rate of tumor eradication.

Research plan:

A total of 660 patients with AJC clinical stage T1c-T2a prostatic carcinoma (Gleason grade 7 to 9 and/or PSA 10–20 ng/ml) will be randomized to implantation with I-125 (144 Gy) versus Pd-103 (124 Gy).

Methodology:

Randomization will be accomplished by the method of random permuted blocks.

Cancer status will be monitored by yearly serial serum PSA. Treatment-related morbidity will be monitored by personal interview, using standard American Urologic Association and Radiation Therapy Oncology Group criteria at 1, 3, 6, 12 and 24 months.

Primary endpoint: Time to treatment failure. Patients with serum PSA above 0.5 ng/ml two years or more after treatment will be considered to have residual or recurrent cancer and to have failed therapy.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 660 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : March 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
U.S. FDA Resources




Primary Outcome Measures :
  1. PSA-based cancer eradication


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • PSA 4-10 ng/ml
  • Gleason score 5 or 6

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00486499


Contacts
Contact: kent E Wallner, md 206-768-5356 kent.wallner@med.va.gov

Locations
United States, Washington
Group Health Cooperative Recruiting
Seattle, Washington, United States, 98104
Contact: Kent E Wallner, MD    206-326-3490    kent.wallner@med.va.gov   
Principal Investigator: Kent E Wallner, MD         
VA Puget Sound Recruiting
Seattle, Washington, United States, 98108
Contact: Kent E Wallner, MD    206-768-5356    kent.wallner@med.va.gov   
Principal Investigator: Kent E Wallner, MD         
Sponsors and Collaborators
VA Puget Sound Health Care System
Dr. Gregory Merrick
Theragenics Corporation
Investigators
Principal Investigator: Kent E Wallner, MD VA Puget Sound, Group Health Cooperative, U of Washington

ClinicalTrials.gov Identifier: NCT00486499     History of Changes
Other Study ID Numbers: 02-4407-V04
First Posted: June 14, 2007    Key Record Dates
Last Update Posted: June 14, 2007
Last Verified: June 2007

Keywords provided by VA Puget Sound Health Care System:
radiation
brachytherapy
prostate
cancer

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