I-125 Versus Pd-103 for Medium Risk Prostate Cancer
| Status: | Recruiting |
|---|---|
| Conditions: | Prostate Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 40 - 90 |
| Updated: | 4/2/2016 |
| Start Date: | March 2003 |
| Contact: | kent E Wallner, md |
| Email: | kent.wallner@med.va.gov |
| Phone: | 206-768-5356 |
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).
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).
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.
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.
Inclusion Criteria:
- PSA 4-10 ng/ml
- Gleason score 5 or 6
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