Overview

This trial is active, not recruiting.

Condition prostate cancer
Treatment radioactive seed implant to prostate
Phase phase 3
Sponsor VA Puget Sound Health Care System
Collaborator Schiffler Cancer Center
Start date January 1998
End date January 2010
Trial size 602 participants
Trial identifier NCT00494039, IP

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment

Primary Outcomes

Measure
Cancer control (biochemical and survival)
time frame: final analysis 2008(?)

Eligibility Criteria

Male participants from 40 years up to 80 years old.

Inclusion Criteria: - Males age 40-80 - PSA 4-10 - Gleason score 5-6 Exclusion Criteria: - Lymph node positive

Additional Information

Official title I-125 Versus Pd-103 for Low Risk Prostate Cancer
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2007.
Information provided to ClinicalTrials.gov by VA Puget Sound Health Care System.