Clinical trial NCT00398281: Dutasteride Followed By Ultrasound-Guided Biopsy in Finding Prostate Cancer
Official title: Detection of Prostate Cancer With Contrast-Enhanced Ultrasound After Treatment With Dutasteride
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Prostate Cancer
Keywords: prostate cancer
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
Collaborators: name: National Cancer Institute (NCI)
First posted: 2006-11-10
Enrollment: 450
Sex: MALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: DIAGNOSTIC

Brief 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.

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.

Eligibility 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

Primary outcomes:
measure: Efficacy of short-term dutasteride in improving prostate cancer detection
measure: Detection rate of prostate cancer
measure: Cost effectiveness of contrast-enhanced ultrasound
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
state: Pennsylvania
Study officials:
affiliation: Sidney Kimmel Cancer Center at Thomas Jefferson University
name: Ethan J. Halpern, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Halpern EJ, Gomella LG, Forsberg F, McCue PA, Trabulsi EJ. Contrast enhanced transrectal ultrasound for the detection of prostate cancer: a randomized, double-blind trial of dutasteride pretreatment. J Urol. 2012 Nov;188(5):1739-45. doi: 10.1016/j.juro.2012.07.021. Epub 2012 Sep 19.