Effect of Dutasteride on Androgen-Response Gene Expression in Patients With Advanced Prostate Cancer

Completed · Phase 2 · Has a placebo group

Conditions studied: Prostate Cancer

In brief

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 (hormone therapy).

Key facts

Study ID

NCT00668642

Run by

Endeavor Health

People needed

20

Starts

2007-03-01

Expected to finish

2013-05-01

Last updated by the study team

2023-08-22

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Known intolerance or allergy to dutasteride
• Concomitant chemotherapy, biologic therapy, or XRT to prostate
• Bilateral orchiectomy
• Prior malignancy within 5 years of registration

Where it is running

• Northwestern University Medical Center — Chicago, Illinois, United States
• University of Chicago Hospitals and Clinics — Chicago, Illinois, United States
• NorthShore University HealthSystem — Evanston, Illinois, United States

Full record on ClinicalTrials.gov

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