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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2007 by VA Puget Sound Health Care System.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00494039
First Posted: June 29, 2007
Last Update Posted: June 29, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Schiffler Cancer Center
Information provided by:
VA Puget Sound Health Care System
  Purpose

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

Research design A total of 600 patients with AJC clinical stage T1c-T2a prostatic carcinoma (Gleason grade 2 to 6, PSA 4 to 10 ng/ml) will be randomized to implantation with I-125 (160 Gy) versus Pd-103 (115 Gy).


Condition Intervention Phase
Prostate Cancer Procedure: Radioactive seed implant to prostate Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: I-125 Versus Pd-103 for Low Risk Prostate Cancer

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Cancer control (biochemical and survival) [ Time Frame: final analysis 2008(?) ]

Enrollment: 602
Study Start Date: January 1998
Estimated Study Completion Date: January 2010
Detailed Description:

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

Research design A total of 600 patients with AJC clinical stage T1c-T2a prostatic carcinoma (Gleason grade 2 to 6, PSA 4 to 10 ng/ml) will be randomized to implantation with I-125 (160 Gy) versus Pd-103 (115 Gy).

Methodology: Patients will be randomized by the method of random permuted blocks.

Cancer status will be monitored by serial serum PSA at 6, 12, 18 and 24 months and yearly thereafter. 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. Patients with serum PSA above 1.0 ng/ml two years after treatment will be considered to have residual or recurrent cancer and to have failed therapy.

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

Inclusion Criteria:

  • Males age 40-80
  • PSA 4-10
  • Gleason score 5-6

Exclusion Criteria:

  • Lymph node positive
  Contacts and Locations
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): NCT00494039


Locations
United States, Washington
Puget Sound VA
Seattle, Washington, United States, 98108
Sponsors and Collaborators
VA Puget Sound Health Care System
Schiffler Cancer Center
Investigators
Study Chair: Kent E Wallner, MD Puget Sound Health Care system
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00494039     History of Changes
Other Study ID Numbers: IP
First Submitted: June 28, 2007
First Posted: June 29, 2007
Last Update Posted: June 29, 2007
Last Verified: June 2007

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

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