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.
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).
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.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
PSA-based cancer eradication
Kent E Wallner, MD
VA Puget Sound, Group Health Cooperative, U of Washington
United States: Federal Government
|Group Health Cooperative||Seattle, Washington 98112|
|VA Puget Sound||Seattle, Washington 98108|