- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00486499
I-125 Versus Pd-103 for Medium Risk Prostate Cancer
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).
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: Kent E Wallner, MD
- Phone Number: 206-768-5356
- Email: kent.wallner@med.va.gov
Study Locations
-
-
Washington
-
Seattle, Washington, United States, 98104
- Recruiting
- Group Health Cooperative
-
Contact:
- Kent E Wallner, MD
- Phone Number: 206-326-3490
- Email: kent.wallner@med.va.gov
-
Principal Investigator:
- Kent E Wallner, MD
-
Seattle, Washington, United States, 98108
- Recruiting
- VA Puget Sound
-
Contact:
- Kent E Wallner, MD
- Phone Number: 206-768-5356
- Email: kent.wallner@med.va.gov
-
Principal Investigator:
- Kent E Wallner, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- PSA 4-10 ng/ml
- Gleason score 5 or 6
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
PSA-based cancer eradication
|
Collaborators and Investigators
Investigators
- Principal Investigator: Kent E Wallner, MD, VA Puget Sound, Group Health Cooperative, U of Washington
Study record dates
Study Major Dates
Study Start
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 02-4407-V04
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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