Prostatectomy-based validation of combined urine and plasma test for predicting high grade prostate cancer

Maher Albitar, Wanlong Ma, Lars Lund, Babak Shahbaba, Edward Uchio, Søren Feddersen, Donald Moylan, Kirk Wojno, Neal Shore

Research output: Contribution to journalJournal articleResearchpeer-review

Abstract

BACKGROUND: Distinguishing between low- and high-grade prostate cancers (PCa) is important, but biopsy may underestimate the actual grade of cancer. We have previously shown that urine/plasma-based prostate-specific biomarkers can predict high grade PCa. Our objective was to determine the accuracy of a test using cell-free RNA levels of biomarkers in predicting prostatectomy results.

METHODS: This multicenter community-based prospective study was conducted using urine/blood samples collected from 306 patients. All recruited patients were treatment-naïve, without metastases, and had been biopsied, designated a Gleason Score (GS) based on biopsy, and assigned to prostatectomy prior to participation in the study. The primary outcome measure was the urine/plasma test accuracy in predicting high grade PCa on prostatectomy compared with biopsy findings. Sensitivity and specificity were calculated using standard formulas, while comparisons between groups were performed using the Wilcoxon Rank Sum, Kruskal-Wallis, Chi-Square, and Fisher's exact test.

RESULTS: GS as assigned by standard 10-12 core biopsies was 3 + 3 in 90 (29.4%), 3 + 4 in 122 (39.8%), 4 + 3 in 50 (16.3%), and > 4 + 3 in 44 (14.4%) patients. The urine/plasma assay confirmed a previous validation and was highly accurate in predicting the presence of high-grade PCa (Gleason ≥3 + 4) with sensitivity between 88% and 95% as verified by prostatectomy findings. GS was upgraded after prostatectomy in 27% of patients and downgraded in 12% of patients.

CONCLUSIONS: This plasma/urine biomarker test accurately predicts high grade cancer as determined by prostatectomy with a sensitivity at 92-97%, while the sensitivity of core biopsies was 78%.

Original languageEnglish
JournalThe Prostate
Volume78
Issue number4
Pages (from-to)294-299
ISSN0270-4137
DOIs
Publication statusPublished - Mar 2018

Fingerprint

Prostatic Neoplasms
Urine
Neoplasm Grading
Prostate
Neoplasms
Outcome Assessment (Health Care)
Prospective Studies
RNA

Keywords

  • Journal Article
  • Gleason score
  • prostate cancer
  • biomarkers
  • high grade
  • active surveillance
  • Prospective Studies
  • Humans
  • Middle Aged
  • Prostatectomy/methods
  • Cell-Free Nucleic Acids/metabolism
  • Male
  • Neoplasm Grading
  • Prostate/pathology
  • Sensitivity and Specificity
  • Adult
  • Aged
  • Biomarkers, Tumor/metabolism
  • Real-Time Polymerase Chain Reaction
  • Prostatic Neoplasms/metabolism

Cite this

Albitar, Maher ; Ma, Wanlong ; Lund, Lars ; Shahbaba, Babak ; Uchio, Edward ; Feddersen, Søren ; Moylan, Donald ; Wojno, Kirk ; Shore, Neal. / Prostatectomy-based validation of combined urine and plasma test for predicting high grade prostate cancer. In: The Prostate. 2018 ; Vol. 78, No. 4. pp. 294-299.
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title = "Prostatectomy-based validation of combined urine and plasma test for predicting high grade prostate cancer",
abstract = "BACKGROUND: Distinguishing between low- and high-grade prostate cancers (PCa) is important, but biopsy may underestimate the actual grade of cancer. We have previously shown that urine/plasma-based prostate-specific biomarkers can predict high grade PCa. Our objective was to determine the accuracy of a test using cell-free RNA levels of biomarkers in predicting prostatectomy results.METHODS: This multicenter community-based prospective study was conducted using urine/blood samples collected from 306 patients. All recruited patients were treatment-na{\"i}ve, without metastases, and had been biopsied, designated a Gleason Score (GS) based on biopsy, and assigned to prostatectomy prior to participation in the study. The primary outcome measure was the urine/plasma test accuracy in predicting high grade PCa on prostatectomy compared with biopsy findings. Sensitivity and specificity were calculated using standard formulas, while comparisons between groups were performed using the Wilcoxon Rank Sum, Kruskal-Wallis, Chi-Square, and Fisher's exact test.RESULTS: GS as assigned by standard 10-12 core biopsies was 3 + 3 in 90 (29.4{\%}), 3 + 4 in 122 (39.8{\%}), 4 + 3 in 50 (16.3{\%}), and > 4 + 3 in 44 (14.4{\%}) patients. The urine/plasma assay confirmed a previous validation and was highly accurate in predicting the presence of high-grade PCa (Gleason ≥3 + 4) with sensitivity between 88{\%} and 95{\%} as verified by prostatectomy findings. GS was upgraded after prostatectomy in 27{\%} of patients and downgraded in 12{\%} of patients.CONCLUSIONS: This plasma/urine biomarker test accurately predicts high grade cancer as determined by prostatectomy with a sensitivity at 92-97{\%}, while the sensitivity of core biopsies was 78{\%}.",
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author = "Maher Albitar and Wanlong Ma and Lars Lund and Babak Shahbaba and Edward Uchio and S{\o}ren Feddersen and Donald Moylan and Kirk Wojno and Neal Shore",
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Prostatectomy-based validation of combined urine and plasma test for predicting high grade prostate cancer. / Albitar, Maher; Ma, Wanlong; Lund, Lars; Shahbaba, Babak; Uchio, Edward; Feddersen, Søren; Moylan, Donald; Wojno, Kirk; Shore, Neal.

In: The Prostate, Vol. 78, No. 4, 03.2018, p. 294-299.

Research output: Contribution to journalJournal articleResearchpeer-review

TY - JOUR

T1 - Prostatectomy-based validation of combined urine and plasma test for predicting high grade prostate cancer

AU - Albitar, Maher

AU - Ma, Wanlong

AU - Lund, Lars

AU - Shahbaba, Babak

AU - Uchio, Edward

AU - Feddersen, Søren

AU - Moylan, Donald

AU - Wojno, Kirk

AU - Shore, Neal

N1 - © 2018 Wiley Periodicals, Inc.

PY - 2018/3

Y1 - 2018/3

N2 - BACKGROUND: Distinguishing between low- and high-grade prostate cancers (PCa) is important, but biopsy may underestimate the actual grade of cancer. We have previously shown that urine/plasma-based prostate-specific biomarkers can predict high grade PCa. Our objective was to determine the accuracy of a test using cell-free RNA levels of biomarkers in predicting prostatectomy results.METHODS: This multicenter community-based prospective study was conducted using urine/blood samples collected from 306 patients. All recruited patients were treatment-naïve, without metastases, and had been biopsied, designated a Gleason Score (GS) based on biopsy, and assigned to prostatectomy prior to participation in the study. The primary outcome measure was the urine/plasma test accuracy in predicting high grade PCa on prostatectomy compared with biopsy findings. Sensitivity and specificity were calculated using standard formulas, while comparisons between groups were performed using the Wilcoxon Rank Sum, Kruskal-Wallis, Chi-Square, and Fisher's exact test.RESULTS: GS as assigned by standard 10-12 core biopsies was 3 + 3 in 90 (29.4%), 3 + 4 in 122 (39.8%), 4 + 3 in 50 (16.3%), and > 4 + 3 in 44 (14.4%) patients. The urine/plasma assay confirmed a previous validation and was highly accurate in predicting the presence of high-grade PCa (Gleason ≥3 + 4) with sensitivity between 88% and 95% as verified by prostatectomy findings. GS was upgraded after prostatectomy in 27% of patients and downgraded in 12% of patients.CONCLUSIONS: This plasma/urine biomarker test accurately predicts high grade cancer as determined by prostatectomy with a sensitivity at 92-97%, while the sensitivity of core biopsies was 78%.

AB - BACKGROUND: Distinguishing between low- and high-grade prostate cancers (PCa) is important, but biopsy may underestimate the actual grade of cancer. We have previously shown that urine/plasma-based prostate-specific biomarkers can predict high grade PCa. Our objective was to determine the accuracy of a test using cell-free RNA levels of biomarkers in predicting prostatectomy results.METHODS: This multicenter community-based prospective study was conducted using urine/blood samples collected from 306 patients. All recruited patients were treatment-naïve, without metastases, and had been biopsied, designated a Gleason Score (GS) based on biopsy, and assigned to prostatectomy prior to participation in the study. The primary outcome measure was the urine/plasma test accuracy in predicting high grade PCa on prostatectomy compared with biopsy findings. Sensitivity and specificity were calculated using standard formulas, while comparisons between groups were performed using the Wilcoxon Rank Sum, Kruskal-Wallis, Chi-Square, and Fisher's exact test.RESULTS: GS as assigned by standard 10-12 core biopsies was 3 + 3 in 90 (29.4%), 3 + 4 in 122 (39.8%), 4 + 3 in 50 (16.3%), and > 4 + 3 in 44 (14.4%) patients. The urine/plasma assay confirmed a previous validation and was highly accurate in predicting the presence of high-grade PCa (Gleason ≥3 + 4) with sensitivity between 88% and 95% as verified by prostatectomy findings. GS was upgraded after prostatectomy in 27% of patients and downgraded in 12% of patients.CONCLUSIONS: This plasma/urine biomarker test accurately predicts high grade cancer as determined by prostatectomy with a sensitivity at 92-97%, while the sensitivity of core biopsies was 78%.

KW - Journal Article

KW - Gleason score

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KW - biomarkers

KW - high grade

KW - active surveillance

KW - Prospective Studies

KW - Humans

KW - Middle Aged

KW - Prostatectomy/methods

KW - Cell-Free Nucleic Acids/metabolism

KW - Male

KW - Neoplasm Grading

KW - Prostate/pathology

KW - Sensitivity and Specificity

KW - Adult

KW - Aged

KW - Biomarkers, Tumor/metabolism

KW - Real-Time Polymerase Chain Reaction

KW - Prostatic Neoplasms/metabolism

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DO - 10.1002/pros.23473

M3 - Journal article

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VL - 78

SP - 294

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JO - The Prostate

JF - The Prostate

SN - 0270-4137

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