Effect of decipher test on adjuvant treatment decision-making among men with high-risk pathology at radical prostatectomy: Results from a multicenter prospective PRO-IMPACT study.

Authors

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John L. Gore

University of Washington School of Medicine, Seattle, WA

John L. Gore , Marguerite du Plessis , Maria Santiago-Jimenez , Kasra Yousefi , Darby Thompson , David Chen , William Clark , Michael Franks , Lawrence Ivan Karsh , Adam S. Kibel , Hyung Lae Kim , Brian R. Lane , Yair Lotan , William Thomas Lowrance , Paul Maroni , Scott David Perrapato , Edouard John Trabulsi , Robert J. Waterhouse Jr., Elai Davicioni , Daniel W. Lin

Organizations

University of Washington School of Medicine, Seattle, WA, GenomeDx Biosciences, Vancouver, BC, Canada, EMMES Canada, Burnaby, BC, Canada, Fox Chase Cancer Center, Philadelphia, PA, Alaska Clinical Research Center, Anchorage, AK, Virginia Urology, Richmond, VA, The Urology Center of Colorado, Denver, CO, Division of Urology, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, Cedars-Sinai Medical Center, Los Angeles, CA, Spectrum Health Hospital System, Grand Rapids, MI, UT Southwestern Medical Center, Dallas, TX, Huntsman Cancer Institute at the University of Utah, Salt Lake City, UT, University of Colorado, Denver Medical Campus, Denver, CO, University of Vermont Medical Center, Burlington, VT, Thomas Jefferson University, Philadelphia, PA, Carolina Urology Partners, Gastonia, NC, University of Washington, Seattle, WA

Research Funding

Pharmaceutical/Biotech Company

Background: The decision to provide adjuvant therapy to men with high risk pathology after radical prostatectomy (RP) is confounded by tremendous uncertainty. We prospectively evaluated the impact of the Decipher test, which predicts metastases after RP, on men and providers decision quality. Methods: 150 adjuvant pts were enrolled by 43 urologists from 19 practices. Pts with pathologic T3 stage or positive surgical margins (SM+) after RP were included. Participating physicians provided a treatment (Tx) recommendation before and after exposure to Decipher test results. Pts completed validated surveys on health-related quality of life, decisional conflict, and PCa-related anxiety. Results: Median patient age at RP was 64 years; 67% and 50% had pT3 and SM+ pathology, respectively. Decipher classified 46%, 22% and 32% of men as low-, intermediate- and high-risk, respectively. Pre-Decipher, observation was recommended for 89%. Post-Decipher, 18% (95% CI 12-25%) of Tx recommendations changed. Men’s Decisional Conflict Scale (DCS) scores decreased (indicating higher decision quality) after exposure to Decipher results (median DCS pre-Decipher 25 [IQR 8-44], median DCS post-Decipher 19 [IQR 2-30], p<0.001), with greatest decreases in the subdomains of decision uncertainty and decision support. Low-risk Decipher results experienced a trend toward decreased PCa-specific anxiety (p=0.13) and a significant reduction in fear of PCa recurrence (p=0.02). Physicians’ median DCS scores decreased from 32 [IQR 28-36] to 28 [IQR 12-42] (p<0.001). Decipher results were associated with the decision to pursue ART in an MVA analysis (OR 1.48; 95% CI 1.19-1.85, p<0.001). Conclusions: Observation is the predominantly prescribed management strategy for men with high risk features at RP. Knowledge of Decipher results was associated with Tx decision-making: men at low risk for metastasis had higher rates of observation recommendations and men at high risk had higher rates of ART recommendations. Decision quality was improved and PCa-specific anxiety was decreased for men exposed to Decipher results. Clinical trial information: NCT02080689

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Abstract Details

Meeting

2017 Genitourinary Cancers Symposium

Session Type

Poster Session

Session Title

Poster Session A: Prostate Cancer

Track

Prostate Cancer,Prostate Cancer

Sub Track

Prostate Cancer - Localized Disease

Clinical Trial Registration Number

NCT02080689

Citation

J Clin Oncol 35, 2017 (suppl 6S; abstract 24)

DOI

10.1200/JCO.2017.35.6_suppl.24

Abstract #

24

Poster Bd #

B11

Abstract Disclosures