I-125 Versus Pd-103 for Medium Risk Prostate Cancer

Prostate Cancer Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00486499
• Other study ID #: 02-4407-V04
• Status: Recruiting
• Phase: Phase 3
• First received: June 12, 2007
• Last updated: June 12, 2007
• Start date: March 2003

Study information

• Verified date: June 2007
• Source: VA Puget Sound Health Care System
• Contact: kent E Wallner, md
• Phone: 206-768-5356
• Email: kent.wallner[@]med.va.gov
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 660
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years to 90 Years

Eligibility

Inclusion Criteria:

• PSA 4-10 ng/ml

• Gleason score 5 or 6

Study Design

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Procedure:
• I-125 versus Pd-103 radioactive seed insertion

Locations

Country	Name	City	State
United States	Group Health Cooperative	Seattle	Washington
United States	VA Puget Sound	Seattle	Washington

Sponsors (3)

Lead Sponsor	Collaborator
VA Puget Sound Health Care System	Dr. Gregory Merrick, Theragenics Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PSA-based cancer eradication