I-125 Versus Pd-103 for Low Risk Prostate Cancer - Full Text View

Sponsors and Collaborators:	Puget Sound Veterans Administration Health Care System Schiffler Cancer Center
Information provided by:	Puget Sound Veterans Administration Health Care System
ClinicalTrials.gov Identifier:	NCT00494039

Purpose

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).

Condition	Intervention	Phase
Prostate Cancer	Procedure: Radioactive seed implant to prostate	Phase III

MedlinePlus related topics: Cancer Prostate Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Efficacy Study
Official Title:	I-125 Versus Pd-103 for Low Risk Prostate Cancer

Further study details as provided by Puget Sound Veterans Administration Health Care System:

Primary Outcome Measures:

Cancer control (biochemical and survival) [ Time Frame: final analysis 2008(?) ]

Enrollment:	602
Study Start Date:	January 1998
Estimated Study Completion Date:	January 2010

Detailed 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.

Eligibility

Ages Eligible for Study:	40 Years to 80 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Males age 40-80
PSA 4-10
Gleason score 5-6

Exclusion Criteria:

Lymph node positive

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00494039

Locations

United States, Washington
Puget Sound VA
Seattle, Washington, United States, 98108

Sponsors and Collaborators

Puget Sound Veterans Administration Health Care System

Schiffler Cancer Center

Investigators

Study Chair:

Kent E Wallner, MD

Puget Sound Health Care system

More Information

Publications of Results:

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.

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.

Study ID Numbers:	IP
Study First Received:	June 28, 2007
Last Updated:	June 28, 2007
ClinicalTrials.gov Identifier:	NCT00494039
Health Authority:	United States: Federal Government

Keywords provided by Puget Sound Veterans Administration Health Care System:

prostate
cancer
radiation
brachytherapy

Study placed in the following topic categories:

Prostatic Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 16, 2009