Status:
COMPLETED
Effect of Dutasteride on Androgen-Response Gene Expression in Patients With Advanced Prostate Cancer
Lead Sponsor:
Endeavor Health
Collaborating Sponsors:
University of Chicago
Northwestern University
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine if the drug dutasteride increases expression of genes that slow the growth of prostate cancer during treatment with intermittent androgen ablation therapy (ho...
Detailed Description
We have shown in a murine model of treatment with intermittent androgen ablation therapy of prostate cancer that when dutasteride is given during the regrowth phase (off-phase) of intermittent therapy...
Eligibility Criteria
Inclusion
- Histologically proven prostate cancer
- Patients are hormone-naive
- Patients either to begin androgen ablation therapy with luteinizing hormone-releasing hormone (LHRH) agonist or already receiving therapy with LHRH agonist
- Advanced prostate cancer with either positive pelvic nodes or bone/visceral metastasis
- Must have an intact prostate (no previous surgery or XRT)
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Recovery from any major infection or surgical procedure
- Signed informed consent
Exclusion
- Known intolerance or allergy to dutasteride
- Concomitant chemotherapy, biologic therapy, or XRT to prostate
- Bilateral orchiectomy
- Prior malignancy within 5 years of registration
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00668642
Start Date
March 1 2007
End Date
May 1 2013
Last Update
August 22 2023
Active Locations (3)
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1
Northwestern University Medical Center
Chicago, Illinois, United States, 60611
2
University of Chicago Hospitals and Clinics
Chicago, Illinois, United States, 60637
3
NorthShore University HealthSystem
Evanston, Illinois, United States, 60201