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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2007 by VA Puget Sound Health Care System.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Dr. Gregory Merrick
Theragenics Corporation
Information provided by:
VA Puget Sound Health Care System
ClinicalTrials.gov Identifier:
NCT00486499
First received: June 12, 2007
Last updated: NA
Last verified: June 2007
History: No changes posted
  Purpose

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 Intervention Phase
Prostate Cancer
Procedure: I-125 versus Pd-103 radioactive seed insertion
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by VA Puget Sound Health Care System:

Primary Outcome Measures:
  • PSA-based cancer eradication

Estimated Enrollment: 660
Study Start Date: March 2003
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.

  Eligibility

Ages Eligible for Study:   40 Years to 90 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • PSA 4-10 ng/ml
  • Gleason score 5 or 6
  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: NCT00486499

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

Locations
United States, Washington
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         
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         
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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00486499     History of Changes
Other Study ID Numbers: 02-4407-V04
Study First Received: June 12, 2007
Last Updated: June 12, 2007
Health Authority: United States: Federal Government

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

ClinicalTrials.gov processed this record on September 22, 2014