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

Primary Purpose

Prostate Cancer

Status
Unknown status
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Radioactive seed implant to prostate
Sponsored by
VA Puget Sound Health Care System
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring prostate, cancer, radiation, brachytherapy

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Lymph node positive

Sites / Locations

  • Puget Sound VA

Outcomes

Primary Outcome Measures

Cancer control (biochemical and survival)

Secondary Outcome Measures

Full Information

First Posted
June 28, 2007
Last Updated
June 28, 2007
Sponsor
VA Puget Sound Health Care System
Collaborators
Schiffler Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT00494039
Brief Title
I-125 Versus Pd-103 for Low Risk Prostate Cancer
Official Title
I-125 Versus Pd-103 for Low Risk Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
June 2007
Overall Recruitment Status
Unknown status
Study Start Date
January 1998 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
VA Puget Sound Health Care System
Collaborators
Schiffler Cancer Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
prostate, cancer, radiation, brachytherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
602 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Radioactive seed implant to prostate
Primary Outcome Measure Information:
Title
Cancer control (biochemical and survival)
Time Frame
final analysis 2008(?)

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Males age 40-80 PSA 4-10 Gleason score 5-6 Exclusion Criteria: Lymph node positive
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kent E Wallner, MD
Organizational Affiliation
Puget Sound Health Care system
Official's Role
Study Chair
Facility Information:
Facility Name
Puget Sound VA
City
Seattle
State/Province
Washington
ZIP/Postal Code
98108
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
14630265
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. doi: 10.1016/s0360-3016(03)01448-2.
Results Reference
result
PubMed Identifier
11895205
Citation
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. doi: 10.1097/00130404-200201000-00012.
Results Reference
result

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

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