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

Primary Purpose

Prostate Cancer

Status

Unknown status

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

I-125 versus Pd-103 radioactive seed insertion

About this trial

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

Eligibility Criteria

40 Years - 90 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

PSA 4-10 ng/ml
Gleason score 5 or 6

Sites / Locations

Group Health CooperativeRecruiting
VA Puget SoundRecruiting

Outcomes

Primary Outcome Measures

PSA-based cancer eradication

Secondary Outcome Measures

Full Information

NCT ID

NCT00486499

First Posted

June 12, 2007

Last Updated

June 12, 2007

Sponsor

VA Puget Sound Health Care System

Collaborators

Dr. Gregory Merrick, Theragenics Corporation

1. Study Identification

Unique Protocol Identification Number

NCT00486499

Brief Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2007

Overall Recruitment Status

Unknown status

Study Start Date

March 2003 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

VA Puget Sound Health Care System

Collaborators

Dr. Gregory Merrick, Theragenics Corporation

4. Oversight

5. Study Description

Brief 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).

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Cancer

Keywords

radiation, brachytherapy, prostate, cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

660 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Procedure

Intervention Name(s)

I-125 versus Pd-103 radioactive seed insertion

Primary Outcome Measure Information:

Title

PSA-based cancer eradication

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: PSA 4-10 ng/ml Gleason score 5 or 6

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

kent E Wallner, md

Phone

206-768-5356

kent.wallner@med.va.gov

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kent E Wallner, MD

Organizational Affiliation

VA Puget Sound, Group Health Cooperative, U of Washington

Official's Role

Principal Investigator

Facility Information:

Facility Name

Group Health Cooperative

City

Seattle

State/Province

Washington

ZIP/Postal Code

98104

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Kent E Wallner, MD

Phone

206-326-3490

kent.wallner@med.va.gov

First Name & Middle Initial & Last Name & Degree

Kent E Wallner, MD

Facility Name

VA Puget Sound

City

Seattle

State/Province

Washington

ZIP/Postal Code

98108

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Kent E Wallner, MD

Phone

206-768-5356

kent.wallner@med.va.gov

First Name & Middle Initial & Last Name & Degree

Kent E Wallner, MD

12. IPD Sharing Statement

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

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