Dutasteride Followed By Ultrasound-Guided Biopsy in Finding Prostate Cancer

Sidney Kimmel Cancer Center at Thomas Jefferson University

Status and phase

Completed

Phase 3

Conditions

Prostate Cancer

Treatments

Drug: dutasteride

Other: placebo

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00398281

CDR0000513051

TJUH-06F-145

Details and patient eligibility

About

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.

Full 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.

Enrollment

450 estimated patients

Sex

Male

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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