@article{3bdafee747de4488b2eaf81235df58a6,
title = "Urinary MyProstateScore (MPS) to Rule out Clinically-Significant Cancer in Men with Equivocal (PI-RADS 3) Multiparametric MRI: Addressing an Unmet Clinical Need",
abstract = "Objective: To evaluate the complementary value of urinary MyProstateScore (MPS) testing and multiparametric MRI (mpMRI) and assess outcomes in patients with equivocal mpMRI. Materials and Methods: Included patients underwent mpMRI followed by urine collection and prostate biopsy at the University of Michigan between 2015 –2019. MPS values were calculated from urine specimens using the validated model based on serum PSA, urinary PCA3, and urinary TMPRSS2:ERG. In the PI-RADS 3 population, the discriminative accuracy of PSA, PSAD, and MPS for GG≥2 cancer was quantified by the AUC curve. Decision curve analysis was used to assess net benefit of MPS relative to PSAD. Results: There were 540 patients that underwent mpMRI and biopsy with MPS available. The prevalence of GG≥2 cancer was 13% for PI-RADS 3, 56% for PI-RADS 4, and 87% for PI-RADS 5. MPS was significantly higher in men with GG≥2 cancer [median 44.9, IQR (29.4 –57.5)] than those with negative or GG1 biopsy [median 29.2, IQR (14.8 –44.2); P <.001] in the overall population and when stratified by PI-RADS score. In the PI-RADS 3 population (n = 121), the AUC for predicting GG≥2 cancer was 0.55 for PSA, 0.62 for PSAD, and 0.73 for MPS. MPS provided the highest net clinical benefit across all pertinent threshold probabilities. Conclusion: In patients that underwent mpMRI and biopsy, MPS was significantly associated with GG≥2 cancer across all PI-RADS scores. In the PI-RADS 3 population, MPS significantly outperformed PSAD in ruling out GG≥2 cancer. These findings suggest a complementary role of MPS testing in patients that have undergone mpMRI.",
author = "Tosoian, {Jeffrey J.} and Udit Singhal and Davenport, {Matthew S.} and Wei, {John T.} and Montgomery, {Jeffrey S.} and George, {Arvin K.} and Salami, {Simpa S.} and Mukundi, {Stanley G.} and Javed Siddiqui and Kunju, {Lakshmi P.} and Tooke, {Benjamin P.} and Ryder, {C. Yoonhee} and Dugan, {Sarah P.} and Zoey Chopra and Rachel Botbyl and Yilin Feng and Sessine, {Michael S.} and Eyrich, {Nicholas W.} and Ross, {Ashley E.} and Trock, {Bruce J.} and Tomlins, {Scott A.} and Palapattu, {Ganesh S.} and Chinnaiyan, {Arul M.} and Niknafs, {Yashar S.} and Morgan, {Todd M.}",
note = "Funding Information: Funding Support: JJT was supported by the National Institutes of Health/National Cancer Institute Advanced Training in Urologic Oncology Grant (T32/CA180984). His research has been funded in part by a University of Michigan Precision Health Research Scholar Award, the SPORE Career Enhancement Program (CA186786), and the Prostate Cancer Foundation Young Investigator Award. US is supported by the Urology Care Foundation – American Urological Association Research Scholar Award sponsored by the Society of Urologic Oncology and SPORE, and a National Institutes of Health Loan Repayment Program award (L30 CA264387). JTW is supported by the Early Detection Research Network and National Cancer Institute. TMM is supported by the A. Alfred Taubman Medical Research Institute. AMC is a Howard Hughes Medical Institute Investigator and an American Cancer Society Research Professor. This work was supported by the Prostate Cancer Foundation, NCI Prostate SPORE (P50 CA186786), an NCI Outstanding Investigator Award (R35CA231996), and an NCI Early Detection Research Network U01 (5U01CA214170-04). Funding Information: JJT, YSN, and AMC are co-founders and have equity in LynxDx, which has licensed the urine biomarkers mentioned in this study from Hologic and the University of Michigan. YSN has leadership roles in LynxDx, AMC serves on the scientific advisory board, and JJT serves as a clinical advisor. MSS is a paid consultant for LnyxDx. The University of Michigan has been issued a patent on ETS gene fusions in prostate cancer on which AMC and SAT are co-inventors. The diagnostic field of use has been licensed to LynxDx. BJT (Johns Hopkins University) has received research funding from MDxHealth and Myriad Genetics. SAT is an employee and equity holder in Strata Oncology. SAT has served as a paid consultant and received research funding (institutional) for Astellas outside of the submitted work. LynxDx or Strata Oncology did not fund the conduct of this study. MSD receives unrelated royalties from Wolters Kluwer. Financial Disclosure: The authors declare that they have no relevant financial interests. Funding Support: JJT was supported by the National Institutes of Health/National Cancer Institute Advanced Training in Urologic Oncology Grant (T32/CA180984). His research has been funded in part by a University of Michigan Precision Health Research Scholar Award, the SPORE Career Enhancement Program (CA186786), and the Prostate Cancer Foundation Young Investigator Award. US is supported by the Urology Care Foundation – American Urological Association Research Scholar Award sponsored by the Society of Urologic Oncology and SPORE, and a National Institutes of Health Loan Repayment Program award (L30 CA264387). JTW is supported by the Early Detection Research Network and National Cancer Institute. TMM is supported by the A. Alfred Taubman Medical Research Institute. AMC is a Howard Hughes Medical Institute Investigator and an American Cancer Society Research Professor. This work was supported by the Prostate Cancer Foundation, NCI Prostate SPORE (P50 CA186786), an NCI Outstanding Investigator Award (R35CA231996), and an NCI Early Detection Research Network U01 (5U01CA214170-04). Funding Information: JJT, YSN, and AMC are co-founders and have equity in LynxDx, which has licensed the urine biomarkers mentioned in this study from Hologic and the University of Michigan. YSN has leadership roles in LynxDx, AMC serves on the scientific advisory board, and JJT serves as a clinical advisor. MSS is a paid consultant for LnyxDx. The University of Michigan has been issued a patent on ETS gene fusions in prostate cancer on which AMC and SAT are co-inventors. The diagnostic field of use has been licensed to LynxDx. BJT (Johns Hopkins University) has received research funding from MDxHealth and Myriad Genetics. SAT is an employee and equity holder in Strata Oncology. SAT has served as a paid consultant and received research funding (institutional) for Astellas outside of the submitted work. LynxDx or Strata Oncology did not fund the conduct of this study. MSD receives unrelated royalties from Wolters Kluwer. Publisher Copyright: {\textcopyright} 2021",
year = "2022",
month = jun,
doi = "10.1016/j.urology.2021.11.033",
language = "English (US)",
volume = "164",
pages = "184--190",
journal = "Urology",
issn = "0090-4295",
publisher = "Elsevier Inc.",
}