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Randomized Controlled Trial
. 2012 Nov;188(5):1739-45.
doi: 10.1016/j.juro.2012.07.021. Epub 2012 Sep 19.

Contrast enhanced transrectal ultrasound for the detection of prostate cancer: a randomized, double-blind trial of dutasteride pretreatment

Ethan J Halpern  1 , Leonard G Gomella, Flemming Forsberg, Peter A McCue, Edouard J Trabulsi
Affiliations
Randomized Controlled Trial

Contrast enhanced transrectal ultrasound for the detection of prostate cancer: a randomized, double-blind trial of dutasteride pretreatment

Ethan J Halpern et al. J Urol. 2012 Nov.

Abstract

Purpose: The identification of clinically significant disease is crucial for optimal treatment of prostate cancer. Selective detection of prostate cancer with increased microvessel density is possible with contrast enhanced ultrasound. Preliminary studies suggest that pretreatment with a 5α-reductase inhibitor may improve the efficiency of contrast enhanced ultrasound targeted biopsy. This study was designed to quantify prostate cancer detection with contrast enhanced ultrasound with or without short-term pretreatment with dutasteride.

Materials and methods: In this randomized, double-blind, placebo controlled trial of oral dutasteride pretreatment, contrast enhanced ultrasound findings were graded and used to direct targeted biopsy (up to 6 cores per prostate). A blinded 12-core systematic biopsy was subsequently performed on every subject based on standard medial and lateral sampling of each sextant.

Results: Of 311 subjects who underwent randomization, 272 completed participation. Positive biopsies were obtained in 276 of 3,264 (8.5%) systematic cores and 203 of 1,237 (16.4%) targeted cores (OR 2.1, 95% CI 1.7-2.6, p <0.001). ROC analysis for the detection of all prostate cancers demonstrated an increase in diagnostic accuracy from pre-contrast imaging to contrast enhanced ultrasound (A(z) 0.60 vs 0.64, p = 0.005). For the detection of high grade cancer (Gleason score 7 or greater) ROC analysis demonstrated improved accuracy for pre-contrast imaging (A(z) 0.74) and contrast enhanced ultrasound (A(z) 0.80, p = 0.0005). For the detection of high grade cancer with greater than 50% biopsy core involvement, excellent accuracy was demonstrated with pre-contrast and contrast enhanced ultrasound, A(z) 0.83 and 0.90, respectively (p = 0.001). Pretreatment with dutasteride had no significant impact on the detection of prostate cancer (p = 0.97).

Conclusions: Contrast enhanced ultrasound targeted biopsy provides a significant benefit for the detection of high grade/high volume prostate cancer.

Trial registration: ClinicalTrials.gov NCT00398281.

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Figures

Figure 1
Figure 1
CONSORT flow diagram of study enrollment. Of 372 patients who were assessed for the study, 311 signed informed consent and were randomized to dutasteride versus placebo. Ultimately, 272 patients completed the protocol and received a CEUS with prostate biopsy. No patient was lost to follow-up.
Figure 2
Figure 2
Transrectal ultrasound near the base of the prostate in a 62 year old male. Targeted and systematic biopsy cores at the right base demonstrated greater than 50% core involvement with Gleason 8 and 9 prostate cancer. The pre-contrast grayscale and color Doppler image (A) is unremarkable, but the post-contrast harmonic grayscale image (B) as well as the post-contrast color (C) and power (D) Doppler images demonstrate hypervascularity associated with the area of positive targeted cores (arrows).
See this image and copyright information in PMC

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