Impact of a protein-based assay that predicts prostate cancer aggressiveness on urologists’ recommendations for active treatment or active surveillance: a randomized clinical utility trial

BMC Urology

Research Article

Jerome P. Richie¹  M. Czarina Acelajado²  Trever Burgon²  Jhiedon Florentino²  Lisa M. DeMaria²  Diana Tamondong-Lachica²  Othman Ouenes²  John W. Peabody³ 

[1] Metamark Genetics, 245 First Street, 10th Floor, Cambridge, MA, USA;QURE Healthcare, 450 Pacific Ave, Suite 200, San Francisco, CA, USA;QURE Healthcare, 450 Pacific Ave, Suite 200, San Francisco, CA, USA;University of California, San Francisco, 500 Beale Street, San Francisco, CA, USA;

关键词: Proteomic biomarker;    Protein-based assay;    Gleason score;    Active surveillance;    Active treatment;    Simulated patients;    Evidence-based treatment;   

DOI  :  10.1186/s12894-017-0243-1

 received in 2016-07-13, accepted in 2017-06-27,  发布年份 2017

来源: Springer

【 摘 要 】

BackgroundOf the more than 1.1 million men diagnosed worldwide annually with prostate cancer, the majority have indolent tumors. Distinguishing between aggressive and indolent cancer is an important clinical challenge. The current approaches for assessing tumor aggressiveness are recognized as insufficient. A validated protein-based assay has been shown to predict tumor aggressiveness from prostate biopsy. The main objective of this study was to measure the clinical utility of this new assay in the management of early-stage prostate cancer.MethodsOne hundred twenty nine board-certified urologists were asked to participate in a randomized, two-arm experiment. We collected data over 2 rounds using simulated clinical cases administered via an online platform. The cases were all newly diagnosed Gleason 3 + 3 or 3 + 4 prostate camcer patients. Urologists in the intervention arm received a 15-min webinar on this protein-based assay and given assay test results for their simulated patients in round 2. Each case had a preferred recommendation of either active surveillance or active treatment. The measured outcome was rate of preferred recommendation, defined as urologists who recommended the proper treatment course. Analyses were done using difference-in-difference estimations.ResultsUsing multinomial logistical regression, urologists who were given the assay results were significantly more likely to choose the preferred recommendation (active surveillance or active treatment) compared to controls (p = 0.004). These urologists were also significantly more likely to involve their patients in the treatment decision compared to controls (p = 0.001).ConclusionsBy providing additional information to inform the physician’s treatment plan, a protein-based assay shows demonstrable clinical utility confirmed through a rigorous randomized controlled study design and regression analyses to test for effects.

【 授权许可】

CC BY   
© The Author(s). 2017