Clinical Utility of a Genomic Classifier in Men Undergoing Radical Prostatectomy: The PRO-IMPACT Trial.

The optimal management of men with prostate cancer at high risk of recurrence postradical prostatectomy is controversial. The clinical utility of the Decipher test was evaluated prospectively on postoperative treatment decisions and patient-reported outcomes.

In the study, 246 eligible men across 19 centers were enrolled. Patients were dichotomized into those considering adjuvant or salvage radiation therapy (ART or SRT). Participating providers submitted a management recommendation before and after receiving the Decipher test results. Treatment received within 12 months and a validated survey on prostate cancer-related anxiety were collected longitudinally.

Pre-Decipher, treatment was recommended for 12% and 40% for the ART and SRT arms, respectively. Post-Decipher, 17% and 30% of treatment recommendations changed in the ART and SRT arms, respectively. Post-Decipher treatment recommendation was administered 78% and 76% of the time in the ART and SRT arms, respectively. Multivariable analysis confirmed that the Decipher score was an independent predictor for change in management for both adjuvant and salvage patients. The number needed to test to change management for one patient was 4. Cancer-specific anxiety decreased among Decipher risk categories in both arms.

Use of Decipher postradical prostatectomy test was associated with postoperative treatment decisions. Overall, high Decipher risk was associated with an increase in treatment intensity whereas low risk scores were associated with a decrease in therapy administered independent of clinical and pathologic risk factors.

Practical radiation oncology. 2019 Nov 20 [Epub ahead of print]

John L Gore, Marguerite du Plessis, Jingbin Zhang, Darlene Dai, Darby J S Thompson, Lawrence Karsh, Brian Lane, Michael Franks, David Y T Chen, Fernando J Bianco, Gordon Brown, William Clark, Adam S Kibel, Hyung Kim, William Lowrance, Murugesan Manoharan, Paul Maroni, Scott Perrapato, Paul Sieber, Edouard J Trabulsi, Robert Waterhouse, Daniel E Spratt, Elai Davicioni, Yair Lotan, Daniel W Lin

University of Washington, Seattle Cancer Care Alliance, Seattle, Washington. Electronic address: ., Decipher Biosciences, Vancouver, BC, Canada., EMMES Canada, Burnaby, BC, Canada., The Urology Center of Colorado, Denver, Colorado., Spectrum Health Medical Group, Grand Rapids, Michigan., Virginia Urology, Richmond, Virginia., Fox Chase Cancer Center, Philadelphia, Pennsylvania., Urological Research Network, Nova Southeastern University, Miami, Florida., Delaware Valley Urology, LLC, Voorhees, New Jersey., Alaska Clinical Research Center, Anchorage, Alaska., Brigham and Women's Hospital, Boston, Massachusetts., Cedars-Sinai Medical Center, Los Angeles, California., Huntsman Cancer Institute, University of Utah, Salt Lake City, Utah., Miller School of Medicine at University of Miami, Miami, Florida., University of Colorado, Anschutz Medical Campus, Aurora, Colorado., University of Vermont Medical Center, Burlington, Vermont., Lancaster Urology, Lancaster, Pennsylvania., Sidney Kimmel Medical College at Thomas Jefferson University, Philadelphia, Pennsylvania., Carolina Urology Partners, Gastonia, North Carolina., Department of Radiation Oncology, University of Michigan, Ann Arbor, Michigan., UT Southwestern Medical Center, Dallas, Texas., University of Washington, Seattle Cancer Care Alliance, Seattle, Washington.