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A Six-Month, Open-Label, Crossover Study Of the Maintenance Of Serum Testosterone And PSA Suppression After Switching Between Lupron 22.5 Mg And Eligard 22.5 Mg Or Zoladex 10.8 Mg And Eligard 22.5 Mg In Patients With Advanced Prostate Cancer

Cancer of Prostate

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

leuprolide acetate

Sponsored by

1. Study Identification

Unique Protocol Identification Number

NCT00220194

Brief Title

A Six-Month, Open-Label, Crossover Study Of the Maintenance Of Serum Testosterone And PSA Suppression After Switching Between Lupron 22.5 Mg And Eligard 22.5 Mg Or Zoladex 10.8 Mg And Eligard 22.5 Mg In Patients With Advanced Prostate Cancer

Official Title

A Six-Month, Open-Label, Crossover Study Of the Maintenance Of Serum Testosterone And PSA Suppression After Switching Between Lupron 22.5 Mg And Eligard 22.5 Mg Or Zoladex 10.8 Mg And Eligard 22.5 Mg In Patients With Advanced Prostate Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

October 2016

Overall Recruitment Status

Completed

Study Start Date

April 2003 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

June 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

San Bernardino Urological Associates Medical Group Inc

4. Oversight

5. Study Description

Brief Summary

Comparing the effect of switching from Lupron and Zoladex to Eligard. PSA and Testosterone levels are measured at set intervals to determine if Eligard is equal or better then Lupron or Zoladex in advanced Prostate Cancer patients.

6. Conditions and Keywords

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

Cancer of Prostate

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

100 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

leuprolide acetate

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: Patient with Advanced Ca, on stable dose of Lupron or Zoladex - Exclusion Criteria: Previous exposure to Eligard.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Franklin M Chu, MD

Organizational Affiliation

San Bernfardino Urological Associates

Official's Role

Principal Investigator

Facility Information:

Facility Name

San bernardino Urological Associates Medical Group

City

San Bernardino

State/Province

California

ZIP/Postal Code

92404

Country

United States

12. IPD Sharing Statement