Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
660 participants
INTERVENTIONAL
2003-03-31
Brief Summary
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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).
Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Interventions
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I-125 versus Pd-103 radioactive seed insertion
Eligibility Criteria
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Inclusion Criteria
* Gleason score 5 or 6
40 Years
90 Years
MALE
No
Sponsors
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Dr. Gregory Merrick
UNKNOWN
Theragenics Corporation
INDUSTRY
VA Puget Sound Health Care System
FED
Principal Investigators
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Kent E Wallner, MD
Role: PRINCIPAL_INVESTIGATOR
VA Puget Sound, Group Health Cooperative, U of Washington
Locations
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Group Health Cooperative
Seattle, Washington, United States
VA Puget Sound
Seattle, Washington, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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02-4407-V04
Identifier Type: -
Identifier Source: org_study_id