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Phase 3
40 Years
90 Years
Open (Enrolling)
Prostate Cancer

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Trial Information

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).


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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

PSA-based cancer eradication

Principal Investigator

Kent E Wallner, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

VA Puget Sound, Group Health Cooperative, U of Washington


United States: Federal Government

Study ID:




Start Date:

March 2003

Completion Date:

Related Keywords:

  • Prostate Cancer
  • radiation
  • brachytherapy
  • prostate
  • cancer
  • Prostatic Neoplasms



Group Health Cooperative Seattle, Washington  98112
VA Puget Sound Seattle, Washington  98108