Trial Information

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.