I-125 Versus Pd-103 for Low Risk Prostate Cancer
- Conditions
- Prostate Cancer
- Registration Number
- NCT00494039
- Lead Sponsor
- VA Puget Sound Health Care System
- Brief 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Male
- Target Recruitment
- 602
- Males age 40-80
- PSA 4-10
- Gleason score 5-6
- Lymph node positive
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Cancer control (biochemical and survival) final analysis 2008(?)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Puget Sound VA
🇺🇸Seattle, Washington, United States