MyProstateScore in men considering repeat biopsy: validation of a simple testing approach

Jeffrey J. Tosoian; Michael S. Sessine; Bruce J. Trock; Ashley E. Ross; Cassie Xie; Yingye Zheng; Nathan L. Samora; Javed Siddiqui; Yashar Niknafs; Zoey Chopra; Scott Tomlins; Lakshmi P. Kunju; Ganesh S. Palapattu; Todd M. Morgan; John T. Wei; Simpa S. Salami; Arul M. Chinnaiyan

doi:10.1038/s41391-022-00633-3

MyProstateScore in men considering repeat biopsy: validation of a simple testing approach

Jeffrey J. Tosoian^*, Michael S. Sessine, Bruce J. Trock, Ashley E. Ross, Cassie Xie, Yingye Zheng, Nathan L. Samora, Javed Siddiqui, Yashar Niknafs, Zoey Chopra, Scott Tomlins, Lakshmi P. Kunju, Ganesh S. Palapattu, Todd M. Morgan, John T. Wei, Simpa S. Salami, Arul M. Chinnaiyan

^*Corresponding author for this work

Urology

Research output: Contribution to journal › Article › peer-review

5 Scopus citations

Abstract

Background: Men with persistent risk of Grade Group (GG) ≥ 2 cancer after a negative biopsy present a unique clinical challenge. The validated MyProstateScore test is clinically-available for pre-biopsy risk stratification. In biopsy-naïve patients, we recently validated a straightforward testing approach to rule-out GG ≥ 2 cancer with 98% negative predictive value (NPV) and 97% sensitivity. In the current study, we established a practical MPS-based testing approach in men with a previous negative biopsy being considered for repeat biopsy. Methods: Patients provided post-digital rectal examination urine prior to repeat biopsy. MyProstateScore was calculated using the validated, locked model including urinary PCA3 and TMPRSS2:ERG scores with serum PSA. In a clinically-appropriate primary (i.e., training) cohort, we identified a lower (rule-out) threshold approximating 90% sensitivity and an upper (rule-in) threshold approximating 80% specificity for GG ≥ 2 cancer. These thresholds were applied to an external validation cohort, and performance measures and clinical outcomes associated with their use were calculated. Results: MyProstateScore thresholds of 15 and 40 met pre-defined performance criteria in the primary cohort (422 patients; median PSA 6.4, IQR 4.3–9.1). In the 268-patient validation cohort, 25 men (9.3%) had GG ≥ 2 cancer on repeat biopsy. The rule-out threshold of 15 provided 100% NPV and sensitivity for GG ≥ 2 cancer and would have prevented 23% of unnecessary biopsies. Use of MyProstateScore >40 to rule-in biopsy would have prevented 67% of biopsies while maintaining 95% NPV. In the validation cohort, the prevalence of GG ≥ 2 cancer was 0% for MyProstateScore 0–15, 6.5% for MyProstateScore 15–40, and 19% for MyProstateScore >40. Conclusions: In patients who previously underwent a negative prostate biopsy, the MyProstateScore values of 15 and 40 yielded clinically-actionable rule-in and rule-out risk groups. Using this straightforward testing approach, MyProstateScore can meaningfully inform patients and physicians weighing the need for repeat biopsy.

Original language	English (US)
Pages (from-to)	563-567
Number of pages	5
Journal	Prostate Cancer and Prostatic Diseases
Volume	26
Issue number	3
DOIs	https://doi.org/10.1038/s41391-022-00633-3
State	Published - Sep 2023

Funding

JJT was funded by the SPORE Career Enhancement Program (CA186786) and is currently funded by the Prostate Cancer Foundation Young Investigator Award (20YOUN11) and an NCI Early Detection Research Network U2C (U2CCA271854-01). MSS was supported by the Rogel Cancer Center Medical Student Scholarship. 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).

ASJC Scopus subject areas

Urology
Oncology
Cancer Research

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

Access to Document

10.1038/s41391-022-00633-3

Cite this

Tosoian, J. J., Sessine, M. S., Trock, B. J., Ross, A. E., Xie, C., Zheng, Y., Samora, N. L., Siddiqui, J., Niknafs, Y., Chopra, Z., Tomlins, S., Kunju, L. P., Palapattu, G. S., Morgan, T. M., Wei, J. T., Salami, S. S., & Chinnaiyan, A. M. (2023). MyProstateScore in men considering repeat biopsy: validation of a simple testing approach. Prostate Cancer and Prostatic Diseases, 26(3), 563-567. https://doi.org/10.1038/s41391-022-00633-3

@article{b77435705160404dacd4e40cab049fe5,

title = "MyProstateScore in men considering repeat biopsy: validation of a simple testing approach",

abstract = "Background: Men with persistent risk of Grade Group (GG) ≥ 2 cancer after a negative biopsy present a unique clinical challenge. The validated MyProstateScore test is clinically-available for pre-biopsy risk stratification. In biopsy-na{\"i}ve patients, we recently validated a straightforward testing approach to rule-out GG ≥ 2 cancer with 98% negative predictive value (NPV) and 97% sensitivity. In the current study, we established a practical MPS-based testing approach in men with a previous negative biopsy being considered for repeat biopsy. Methods: Patients provided post-digital rectal examination urine prior to repeat biopsy. MyProstateScore was calculated using the validated, locked model including urinary PCA3 and TMPRSS2:ERG scores with serum PSA. In a clinically-appropriate primary (i.e., training) cohort, we identified a lower (rule-out) threshold approximating 90% sensitivity and an upper (rule-in) threshold approximating 80% specificity for GG ≥ 2 cancer. These thresholds were applied to an external validation cohort, and performance measures and clinical outcomes associated with their use were calculated. Results: MyProstateScore thresholds of 15 and 40 met pre-defined performance criteria in the primary cohort (422 patients; median PSA 6.4, IQR 4.3–9.1). In the 268-patient validation cohort, 25 men (9.3%) had GG ≥ 2 cancer on repeat biopsy. The rule-out threshold of 15 provided 100% NPV and sensitivity for GG ≥ 2 cancer and would have prevented 23% of unnecessary biopsies. Use of MyProstateScore >40 to rule-in biopsy would have prevented 67% of biopsies while maintaining 95% NPV. In the validation cohort, the prevalence of GG ≥ 2 cancer was 0% for MyProstateScore 0–15, 6.5% for MyProstateScore 15–40, and 19% for MyProstateScore >40. Conclusions: In patients who previously underwent a negative prostate biopsy, the MyProstateScore values of 15 and 40 yielded clinically-actionable rule-in and rule-out risk groups. Using this straightforward testing approach, MyProstateScore can meaningfully inform patients and physicians weighing the need for repeat biopsy.",

author = "Tosoian, {Jeffrey J.} and Sessine, {Michael S.} and Trock, {Bruce J.} and Ross, {Ashley E.} and Cassie Xie and Yingye Zheng and Samora, {Nathan L.} and Javed Siddiqui and Yashar Niknafs and Zoey Chopra and Scott Tomlins and Kunju, {Lakshmi P.} and Palapattu, {Ganesh S.} and Morgan, {Todd M.} and Wei, {John T.} and Salami, {Simpa S.} and Chinnaiyan, {Arul M.}",

note = "Publisher Copyright: {\textcopyright} 2022, The Author(s).",

year = "2023",

month = sep,

doi = "10.1038/s41391-022-00633-3",

language = "English (US)",

volume = "26",

pages = "563--567",

journal = "Prostate Cancer and Prostatic Diseases",

issn = "1365-7852",

publisher = "Nature Publishing Group",

number = "3",

}

Tosoian, JJ, Sessine, MS, Trock, BJ, Ross, AE, Xie, C, Zheng, Y, Samora, NL, Siddiqui, J, Niknafs, Y, Chopra, Z, Tomlins, S, Kunju, LP, Palapattu, GS, Morgan, TM, Wei, JT, Salami, SS & Chinnaiyan, AM 2023, 'MyProstateScore in men considering repeat biopsy: validation of a simple testing approach', Prostate Cancer and Prostatic Diseases, vol. 26, no. 3, pp. 563-567. https://doi.org/10.1038/s41391-022-00633-3

TY - JOUR

T1 - MyProstateScore in men considering repeat biopsy

T2 - validation of a simple testing approach

AU - Tosoian, Jeffrey J.

AU - Sessine, Michael S.

AU - Trock, Bruce J.

AU - Ross, Ashley E.

AU - Xie, Cassie

AU - Zheng, Yingye

AU - Samora, Nathan L.

AU - Siddiqui, Javed

AU - Niknafs, Yashar

AU - Chopra, Zoey

AU - Tomlins, Scott

AU - Kunju, Lakshmi P.

AU - Palapattu, Ganesh S.

AU - Morgan, Todd M.

AU - Wei, John T.

AU - Salami, Simpa S.

AU - Chinnaiyan, Arul M.

PY - 2023/9

Y1 - 2023/9

N2 - Background: Men with persistent risk of Grade Group (GG) ≥ 2 cancer after a negative biopsy present a unique clinical challenge. The validated MyProstateScore test is clinically-available for pre-biopsy risk stratification. In biopsy-naïve patients, we recently validated a straightforward testing approach to rule-out GG ≥ 2 cancer with 98% negative predictive value (NPV) and 97% sensitivity. In the current study, we established a practical MPS-based testing approach in men with a previous negative biopsy being considered for repeat biopsy. Methods: Patients provided post-digital rectal examination urine prior to repeat biopsy. MyProstateScore was calculated using the validated, locked model including urinary PCA3 and TMPRSS2:ERG scores with serum PSA. In a clinically-appropriate primary (i.e., training) cohort, we identified a lower (rule-out) threshold approximating 90% sensitivity and an upper (rule-in) threshold approximating 80% specificity for GG ≥ 2 cancer. These thresholds were applied to an external validation cohort, and performance measures and clinical outcomes associated with their use were calculated. Results: MyProstateScore thresholds of 15 and 40 met pre-defined performance criteria in the primary cohort (422 patients; median PSA 6.4, IQR 4.3–9.1). In the 268-patient validation cohort, 25 men (9.3%) had GG ≥ 2 cancer on repeat biopsy. The rule-out threshold of 15 provided 100% NPV and sensitivity for GG ≥ 2 cancer and would have prevented 23% of unnecessary biopsies. Use of MyProstateScore >40 to rule-in biopsy would have prevented 67% of biopsies while maintaining 95% NPV. In the validation cohort, the prevalence of GG ≥ 2 cancer was 0% for MyProstateScore 0–15, 6.5% for MyProstateScore 15–40, and 19% for MyProstateScore >40. Conclusions: In patients who previously underwent a negative prostate biopsy, the MyProstateScore values of 15 and 40 yielded clinically-actionable rule-in and rule-out risk groups. Using this straightforward testing approach, MyProstateScore can meaningfully inform patients and physicians weighing the need for repeat biopsy.

AB - Background: Men with persistent risk of Grade Group (GG) ≥ 2 cancer after a negative biopsy present a unique clinical challenge. The validated MyProstateScore test is clinically-available for pre-biopsy risk stratification. In biopsy-naïve patients, we recently validated a straightforward testing approach to rule-out GG ≥ 2 cancer with 98% negative predictive value (NPV) and 97% sensitivity. In the current study, we established a practical MPS-based testing approach in men with a previous negative biopsy being considered for repeat biopsy. Methods: Patients provided post-digital rectal examination urine prior to repeat biopsy. MyProstateScore was calculated using the validated, locked model including urinary PCA3 and TMPRSS2:ERG scores with serum PSA. In a clinically-appropriate primary (i.e., training) cohort, we identified a lower (rule-out) threshold approximating 90% sensitivity and an upper (rule-in) threshold approximating 80% specificity for GG ≥ 2 cancer. These thresholds were applied to an external validation cohort, and performance measures and clinical outcomes associated with their use were calculated. Results: MyProstateScore thresholds of 15 and 40 met pre-defined performance criteria in the primary cohort (422 patients; median PSA 6.4, IQR 4.3–9.1). In the 268-patient validation cohort, 25 men (9.3%) had GG ≥ 2 cancer on repeat biopsy. The rule-out threshold of 15 provided 100% NPV and sensitivity for GG ≥ 2 cancer and would have prevented 23% of unnecessary biopsies. Use of MyProstateScore >40 to rule-in biopsy would have prevented 67% of biopsies while maintaining 95% NPV. In the validation cohort, the prevalence of GG ≥ 2 cancer was 0% for MyProstateScore 0–15, 6.5% for MyProstateScore 15–40, and 19% for MyProstateScore >40. Conclusions: In patients who previously underwent a negative prostate biopsy, the MyProstateScore values of 15 and 40 yielded clinically-actionable rule-in and rule-out risk groups. Using this straightforward testing approach, MyProstateScore can meaningfully inform patients and physicians weighing the need for repeat biopsy.

UR - http://www.scopus.com/inward/record.url?scp=85145222998&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85145222998&partnerID=8YFLogxK

U2 - 10.1038/s41391-022-00633-3

DO - 10.1038/s41391-022-00633-3

M3 - Article

C2 - 36585434

AN - SCOPUS:85145222998

SN - 1365-7852

VL - 26

SP - 563

EP - 567

JO - Prostate Cancer and Prostatic Diseases

JF - Prostate Cancer and Prostatic Diseases

IS - 3

ER -

MyProstateScore in men considering repeat biopsy: validation of a simple testing approach

Abstract

Funding

ASJC Scopus subject areas

UN SDGs

Access to Document

Other files and links

Fingerprint

Cite this