I-125 Versus Pd-103 for Medium Risk Prostate Cancer | NCT00486499

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

NCT00486499

Sponsor

VA Puget Sound Health Care System

Status

Unknown status

Last Update Posted

Jun 14, 2007Estimated

Enrollment

660Estimated

Phase

Phase 3

Conditions

Prostate Cancer

Interventions

I-125 versus Pd-103 radioactive seed insertion

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2007

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2003

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Jun 12, 2007

First Submission Date that Met QC Criteria

Jun 12, 2007

First Posted Date

Jun 14, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 12, 2007

Last Update Posted Date

Jun 14, 2007Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

VA Puget Sound Health Care SystemFED

Collaborators

Name	Class
Dr. Gregory Merrick	UNKNOWN
Theragenics Corporation	INDUSTRY

Description Module

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:

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

660Estimated

Name	Type	Description	Arm Group Labels	Other Names
I-125 versus Pd-103 radioactive seed insertion	Procedure

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
PSA-based cancer eradication

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
kent E Wallner, md	Contact	206-768-5356		kent.wallner@med.va.gov

Overall Officials

Name	Affiliation	Role
Kent E Wallner, MD	VA Puget Sound, Group Health Cooperative, U of Washington	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Group Health Cooperative	Recruiting	Seattle	Washington	98104	United States

Condition Browse Module

MeSH Terms

ID	Term
D011471	Prostatic Neoplasms
D009369	Neoplasms

Ancestor Terms

ID	Term
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D005832	Genital Diseases, Male

Browse Leaves

Not provided

Browse Branches

Not provided