NCT00486499

I-125 Versus Pd-103 for Medium Risk Prostate Cancer

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 660 (estimated)
• Sponsor: VA Puget Sound Health Care System · Federal
• Sex: Male
• Age: 40 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

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).

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.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
PROCEDURE	I-125 versus Pd-103 radioactive seed insertion

Timeline

• Start date: 2003-03-01
• First posted: 2007-06-14
• Last updated: 2007-06-14

Locations

2 sites across 1 country: United States