NCT00494039

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 602 (actual)
• Sponsor: VA Puget Sound Health Care System · Federal
• Sex: Male
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

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.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
PROCEDURE	Radioactive seed implant to prostate

Timeline

• Start date: 1998-01-01
• Completion: 2010-01-01
• First posted: 2007-06-29
• Last updated: 2007-06-29

Locations

1 site across 1 country: United States