Dutasteride Followed By Ultrasound-Guided Biopsy in Finding Prostate Cancer

• Status: Completed
• Trial end date: 2012-09-01
• Target enrollment: 0
• Participant gender: Male

Summary

RATIONALE: Diagnostic procedures, such as ultrasound-guided biopsy, may help find prostate cancer. Dutasteride may improve the ability of ultrasound-guided biopsy to find prostate cancer. It is not yet known whether dutasteride followed by ultrasound-guided biopsy is more effective than a placebo followed by ultrasound-guided biopsy in finding prostate cancer.

PURPOSE: This randomized phase III trial is studying dutasteride and ultrasound-guided biopsy to see how well they find prostate cancer compared with a placebo and ultrasound-guided biopsy.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sidney Kimmel Cancer Center at Thomas Jefferson University
• Collaborator: National Cancer Institute (NCI)
• Treatments: Dutasteride

Criteria

DISEASE CHARACTERISTICS:

• Suspected prostate cancer due to 1 of the following criteria:

• Prior abnormal digital rectal exam

• Elevated prostate-specific antigen (PSA) ≥ 2.6 ng/mL within the past 90 days

• PSA velocity > 0.75 ng/mL/year

• Must be planning to undergo a transrectal ultrasound with biopsy

PATIENT CHARACTERISTICS:

• Must be in adequate physical health to tolerate a prolonged transrectal examination and biopsy

• Must not be clinically unstable, severely ill, or moribund

PRIOR CONCURRENT THERAPY:

• More than 30 days since prior biopsy of the prostate

• More than 1 week since prior acetylsalicylic acid or blood thinner

• More than 30 days since prior participation in a clinical trial involving an investigational drug

• No prior therapy for prostate cancer

• No other concurrent 5-alpha reductase inhibitor