Prostate Cancer
Conditions
Keywords
prostate, cancer, radiation, brachytherapy
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.
Interventions
PROCEDURERadioactive seed implant to prostate
Sponsors
Schiffler Cancer Center
VA Puget Sound Health Care System
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
40 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Males age 40-80 * PSA 4-10 * Gleason score 5-6
Exclusion criteria
* Lymph node positive
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cancer control (biochemical and survival) | final analysis 2008(?) |
Countries
United States
Outcome results
None listed