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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00494039
• Other study ID #: IP
• Status: Active, not recruiting
• Phase: Phase 3
• First received: June 28, 2007
• Last updated: June 28, 2007
• Start date: January 1998
• Est. completion date: January 2010

Study information

• Verified date: June 2007
• Source: VA Puget Sound Health Care System
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 602
• Est. completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years to 80 Years

Eligibility

Inclusion Criteria:

• Males age 40-80

• PSA 4-10

• Gleason score 5-6

Exclusion Criteria:

• Lymph node positive

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:
• Radioactive seed implant to prostate

Locations

Country	Name	City	State
United States	Puget Sound VA	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
VA Puget Sound Health Care System	Schiffler Cancer Center

Country where clinical trial is conducted

United States, 

References & Publications (2)

Wallner K, Merrick G, True L, Cavanagh W, Simpson C, Butler W. I-125 versus Pd-103 for low-risk prostate cancer: morbidity outcomes from a prospective randomized multicenter trial. Cancer J. 2002 Jan-Feb;8(1):67-73. — View Citation

Wallner K, Merrick G, True L, Sutlief S, Cavanagh W, Butler W. 125I versus 103Pd for low-risk prostate cancer: preliminary PSA outcomes from a prospective randomized multicenter trial. Int J Radiat Oncol Biol Phys. 2003 Dec 1;57(5):1297-303. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cancer control (biochemical and survival)		final analysis 2008(?)