Dutasteride Followed By Ultrasound-Guided Biopsy in Finding Prostate Cancer

Condition(s) targeted: Prostate Cancer

Intervention: dutasteride (Drug); placebo (Other)

Phase: Phase 3

Status: Completed

Sponsored by: Kimmel Cancer Center (KCC)

Official(s) and/or principal investigator(s):
Ethan J. Halpern, MD, Principal Investigator, Affiliation: Kimmel Cancer Center (KCC)

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.

Official title: Detection of Prostate Cancer With Contrast-Enhanced Ultrasound After Treatment With Dutasteride

Study design: Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Diagnostic

Primary outcome:

Efficacy of short-term dutasteride in improving prostate cancer detection

Detection rate of prostate cancer

Cost effectiveness of contrast-enhanced ultrasound

Detailed description: OBJECTIVES:

- Determine the efficacy of dutasteride followed by contrast-enhanced, ultrasound-guided

targeted biopsy in detecting prostate cancer.

- Determine the detection rate of prostate cancer with targeted biopsy using

contrast-enhanced ultrasound combined with dutasteride.

- Determine the efficacy of targeted biopsy using contrast-enhanced ultrasound vs

systematic biopsy in diagnosing clinically significant prostate cancer.

- Determine the reduction in post-biopsy bleeding after dutasteride in these patients.

- Determine the cost effectiveness of this regimen in these patients.

OUTLINE: This is a prospective, double-blind, placebo-controlled, randomized study. Patients are randomized to 1 of 2 arms.

- Arm I: Patients receive oral dutasteride once daily on days 1-14.

- Arm II: Patients receive oral placebo once daily on days 1-14. On day 14, patients in

both arms undergo blood collection and contrast-enhanced (perflutren protein-type A microspheres) transrectal ultrasound. Conventional gray-scale imaging, color Doppler imaging, and power Doppler imaging are performed. Biopsies are then performed; first up to 6 targeted ultrasound-guided biopsies and then up to 12 systematic biopsies. After completion of study procedures, patients are followed at 1 day. PROJECTED ACCRUAL: A total of 450 patients will be accrued for this study.

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Male.

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

Kimmel Cancer Center at Thomas Jefferson University - Philadelphia, Philadelphia, Pennsylvania 19107-5541, United States

Clinical trial summary from the National Cancer Institute's PDQ® database

Starting date: November 2006
Last updated: January 9, 2014