I-125 Versus Pd-103 for Low Risk Prostate Cancer
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.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Cancer control (biochemical and survival)
final analysis 2008(?)
Kent E Wallner, MD
Puget Sound Health Care system
United States: Federal Government
|Puget Sound VA||Seattle, Washington 98108|