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

• Status: Completed
• Trial end date: 2013-05-01
• Target enrollment: 0
• Participant gender: Male

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 (hormone therapy).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: NorthShore University HealthSystem; NorthShore University HealthSystem Research Institute
• Collaborators: Northwestern University; University of Chicago
• Treatments: Androgens; Dutasteride

Criteria

Inclusion Criteria:

• Histologically proven prostate cancer

• Patients are hormone-naive

• Patients either to begin androgen ablation therapy with 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)

• ECOG performance status 0-2

• Recovery from any major infection or surgical procedure

• Signed informed consent

Exclusion Criteria:

• Known intolerance or allergy to dutasteride

• Concomitant chemotherapy, biologic therapy, or XRT to prostate

• Bilateral orchiectomy

• Prior malignancy within 5 years of registration