Prostate Cancer
Conditions
Keywords
radiation, brachytherapy, prostate, cancer
Brief 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.
Interventions
PROCEDUREI-125 versus Pd-103 radioactive seed insertion
Sponsors
Dr. Gregory Merrick
Theragenics Corporation
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 90 Years
Healthy volunteers
No
Inclusion criteria
* PSA 4-10 ng/ml * Gleason score 5 or 6
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PSA-based cancer eradication | — |
Countries
United States
Contacts
Primary Contactkent E Wallner, md
Outcome results
None listed