Raadpleeg ook de lijst van niet-toxische ondersteuning bij prostaatkanker van arts-bioloog drs. Engelbert Valstar.

En als donateur kunt u ook korting krijgen bij verschillende bedrijven, waaronder bij MEDpro voor o.a. prostasol  een veel gebruikt natuurlijk middel bij prostaatkanker als alternatief voor hormoontherapie

Zie ook in gerelateerde artikelen

19 april 2024: Bron: JAMA Oncol. Published online April 18, 2024

Urinetest met 18 genen test voorspelt beter of prostaatkanker zich als hooggradig zal ontwikkelen in vergelijking met de eerdere MSP2 test. De urinetesten zijn bedoeld om mannen met verhoogde niveaus van prostaatspecifiek antigeen (PSA) te evalueren om te helpen bepalen of zij risico lopen op agressieve hooggradige prostaatkanker (Gleasonscores hoger dan 5 bv) en daarom aanvullende vervolgtesten nodig hebben, zoals biopsieën of in beeld brengen via bv een MRI of scans. Dat blijkt uit onderzoek van de universiteit van Michigan.

In deze diagnostische studie met 761 mannen in de ontwikkelingstudiegroep en 743 mannen in de validatiegroep werden nieuwe kankerspecifieke en hooggradige kankerspecifieke genen geïdentificeerd uit RNA-sequentiegegevens en optimaal gemodelleerd in een ontwikkelingsstudiegroep, wat een 18-genenanalyse opleverde.

In het onderzoek vergeleken de onderzoekers de resultaten van de urinetest die dus 18 genen testte met die van andere veelgebruikte reflextests voor prostaatkanker en ontdekten dat deze een hogere diagnostische nauwkeurigheid had, waardoor onnodige biopsieën konden worden verminderd terwijl de hoge gevoeligheid voor het detecteren van hooggradige prostaatkanker behouden bleef.

Hoewel PSA-testen vaak worden gebruikt om mannen te screenen op prostaatkanker, lijdt het aan een gebrek aan specificiteit, zowel voor prostaatkanker zelf als voor hooggradige prostaatkanker die een snelle behandeling vereist en patiënten niet in een wait-and-see programma / observatieprogramma kunnen. Daarom is er veel onderzoek gedaan naar de ontwikkeling van tests die kunnen beoordelen of een persoon met een hoge PSA-score waarschijnlijk een agressieve kanker zal hebben.

Uit het abstract de resultaten vertaald in het Nederlands:
  • Van de 761 mannen in de ontwikkelingsstudiegroep was de mediane (IQR) leeftijd 63 (58-68) jaar en het mediane (IQR) PSA-niveau 5,6 (4,6-7,2) ng/ml;
  • van de 743 mannen in de validatiegroep was de mediane (IQR) leeftijd 62 (57-68) jaar en het mediane (IQR) PSA-niveau 5,6 (4,1-8,0) ng/ml.
  • In de validatiegroep hadden 151 patiënten (20,3%) hoogwaardige PCa bij biopsie. De oppervlakte onder de karakteristieke curvewaarden van de ontvanger waren 0,60 met alleen PSA, 0,66 met de risicocalculator, 0,77 met PHI, 0,76 met het afgeleide multiplex 2-genenmodel, 0,72 met het afgeleide multiplex 3-genenmodel en 0,74 met de originele MPS model vergeleken met 0,81 bij gebruik van het MPS2-model en 0,82 bij gebruik van het MPS2+-model.
  • Bij een gevoeligheid van 95% zou het MPS2-model onnodige biopsieën hebben verminderd die zijn uitgevoerd in de initiële biopsiepopulatie (bereik voor andere tests, 15% tot 30%; bereik voor MPS2, 35% tot 42%) en herhaalde biopsiepopulatie (bereik voor andere tests 9% tot 21%; bereik voor MPS2, 46% tot 51%).
  • In de relevante subgroepen hadden de MPS2-modellen negatief voorspellende waarden van 95% tot 99% voor kankers van GG 2 of hoger en van 99% voor kankers van GG 3 of hoger.

Conclusie van de onderzoekers van de studie: 

In deze studie had een nieuwe prostaatkankertest met 18 genen een hogere diagnostische nauwkeurigheid voor hooggradige prostaatkanker (PCa) vergeleken met bestaande biomarkertests. Klinisch gezien zou het gebruik van deze urinetest het onnodig aantal uitgevoerde biopsieën aanzienlijk hebben verminderd, terwijl de zeer gevoelige detectie van hooggradige prostaatkanker behouden bleef. Deze gegevens ondersteunen het gebruik van deze nieuwe PCa-biomarkertest bij patiënten met verhoogde PSA-waarden om de potentiële schade van PCa-screening te verminderen en tegelijkertijd de voordelen op de lange termijn te behouden.


Het volledige studierapport is in Jama gepubliceerd en gratis in te zien:
Original Investigation
April 18, 2024

Development and Validation of an 18-Gene Urine Test for High-Grade Prostate Cancer

Jeffrey J. Tosoian, MD, MPH1,2; Yuping Zhang, PhD3; Lanbo Xiao, PhD3; et alCassie Xie, MS4; Nathan L. Samora, MD1; Yashar S. Niknafs, PhD3; Zoey Chopra, MA3; Javed Siddiqui, MS3; Heng Zheng, MD3; Grace Herron, BA3; Neil Vaishampayan, BS3; Hunter S. Robinson, MD1; Kumaran Arivoli, BS3; Bruce J. Trock, PhD5; Ashley E. Ross, MD, PhD6; Todd M. Morgan, MD7; Ganesh S. Palapattu, MD7; Simpa S. Salami, MD, MPH7; Lakshmi P. Kunju, MD3; Scott A. Tomlins, MD, PhD7,8; Lori J. Sokoll, PhD5; Daniel W. Chan, PhD5; Sudhir Srivastava, PhD9; Ziding Feng, PhD4; Martin G. Sanda, MD10; Yingye Zheng, PhD4; John T. Wei, MD7; Arul M. Chinnaiyan, MD, PhD3,7,11; for the EDRN-PCA3 Study Group
Author Affiliations Article Information
JAMA Oncol. Published online April 18, 2024. doi:10.1001/jamaoncol.2024.0455
Key Points

Question  Can a new 18-gene urinary test for high-grade prostate cancer (ie, grade group 2 or greater) improve prostate-specific antigen (PSA) screening outcomes relative to existing biomarker tests?

Findings  In this diagnostic study including 761 men in the development cohort and 743 men in the validation cohort, novel cancer-specific and high-grade cancer-specific genes were identified from RNA sequencing data and optimally modeled in a development cohort, yielding an 18-gene test for high-grade prostate cancer. Applying a testing approach with 95% sensitivity for high-grade prostate cancer to an external validation population, use of the 18-gene test would have reduced the number of unnecessary biopsies performed relative to current guideline-endorsed tests.

Meaning  The new 18-gene prostate cancer test may reduce more burdensome additional testing (eg, imaging and biopsy) while maintaining highly sensitive detection of high-grade cancer in patients undergoing PSA screening.

Abstract

Importance  Benefits of prostate cancer (PCa) screening with prostate-specific antigen (PSA) alone are largely offset by excess negative biopsies and overdetection of indolent cancers resulting from the poor specificity of PSA for high-grade PCa (ie, grade group 2 or greater).

Objective  To develop a multiplex urinary panel for high-grade PCa and validate its external performance relative to current guideline-endorsed biomarkers.

Design, Setting, and Participants  RNA sequencing analysis of 58 724 genes identified 54 markers of PCa, including 17 markers uniquely overexpressed by high-grade cancers. Gene expression and clinical factors were modeled in a new urinary test for high-grade PCa (MyProstateScore 2.0 ). Optimal models were developed in parallel without prostate volume (MPS2) and with prostate volume (MPS2+). The locked models underwent blinded external validation in a prospective National Cancer Institute trial cohort. Data were collected from January 2008 to December 2020, and data were analyzed from November 2022 to November 2023.

Exposure  Protocolized blood and urine collection and transrectal ultrasound-guided systematic prostate biopsy.

Main Outcomes and Measures  Multiple biomarker tests were assessed in the validation cohort, including serum PSA alone, the Prostate Cancer Prevention Trial risk calculator, and the Prostate Health Index (PHI) as well as derived multiplex 2-gene and 3-gene models, the original 2-gene MPS test, and the 18-gene MPS2 models. Under a testing approach with 95% sensitivity for PCa of GG 2 or greater, measures of diagnostic accuracy and clinical consequences of testing were calculated. Cancers of GG 3 or greater were assessed secondarily.

Results  Of 761 men included in the development cohort, the median (IQR) age was 63 (58-68) years, and the median (IQR) PSA level was 5.6 (4.6-7.2) ng/mL; of 743 men included in the validation cohort, the median (IQR) age was 62 (57-68) years, and the median (IQR) PSA level was 5.6 (4.1-8.0) ng/mL. In the validation cohort, 151 (20.3%) had high-grade PCa on biopsy. Area under the receiver operating characteristic curve values were 0.60 using PSA alone, 0.66 using the risk calculator, 0.77 using PHI, 0.76 using the derived multiplex 2-gene model, 0.72 using the derived multiplex 3-gene model, and 0.74 using the original MPS model compared with 0.81 using the MPS2 model and 0.82 using the MPS2+ model. At 95% sensitivity, the MPS2 model would have reduced unnecessary biopsies performed in the initial biopsy population (range for other tests, 15% to 30%; range for MPS2, 35% to 42%) and repeat biopsy population (range for other tests, 9% to 21%; range for MPS2, 46% to 51%). Across pertinent subgroups, the MPS2 models had negative predictive values of 95% to 99% for cancers of GG 2 or greater and of 99% for cancers of GG 3 or greater.

Conclusions and Relevance  In this study, a new 18-gene PCa test had higher diagnostic accuracy for high-grade PCa relative to existing biomarker tests. Clinically, use of this test would have meaningfully reduced unnecessary biopsies performed while maintaining highly sensitive detection of high-grade cancers. These data support use of this new PCa biomarker test in patients with elevated PSA levels to reduce the potential harms of PCa screening while preserving its long-term benefits.

Article Information

Accepted for Publication: December 6, 2023.

Published Online: April 18, 2024. doi:10.1001/jamaoncol.2024.0455

Open Access: This is an open access article distributed under the terms of the CC-BY License. © 2024 Tosoian JJ et al. JAMA Oncology.

Corresponding Author: Arul M. Chinnaiyan, MD, PhD, Department of Pathology, University of Michigan, 1500 E Medical Center Dr, 5316 Rogel Cancer Center, Ann Arbor, MI 48109-0940 (arul@med.umich.edu).

Author Contributions: Drs Y. Zheng and Chinnaiyan had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. Drs Tosoian, Zhang, and Xiao serve as co–first authors. Drs Wei and Chinnaiyan serve as co–senior authors.

Concept and design: Tosoian, Xiao, Niknafs, Tomlins, Srivastava, Feng, Sanda, Y. Zheng, Chinnaiyan.

Acquisition, analysis, or interpretation of data: Tosoian, Zhang, Xiao, Xie, Samora, Niknafs, Chopra, Siddiqui, H. Zheng, Herron, Vaishampayan, Robinson, Arivoli, Trock, Ross, Morgan, Palapattu, Salami, Kunju, Sokoll, Chan, Sanda, Y. Zheng, Wei, Chinnaiyan.

Drafting of the manuscript: Tosoian, Zhang, Xiao, Xie, Samora, Niknafs, Trock, Chinnaiyan.

Critical review of the manuscript for important intellectual content: Tosoian, Xiao, Samora, Niknafs, Chopra, Siddiqui, H. Zheng, Herron, Vaishampayan, Robinson, Arivoli, Trock, Ross, Morgan, Palapattu, Salami, Kunju, Tomlins, Sokoll, Chan, Srivastava, Feng, Sanda, Y. Zheng, Wei, Chinnaiyan.

Statistical analysis: Zhang, Xie, Samora, Niknafs, Vaishampayan, Arivoli, Trock, Salami, Y. Zheng.

Obtained funding: Tosoian, Xiao, Niknafs, Tomlins, Chan, Feng, Sanda, Chinnaiyan.

Administrative, technical, or material support: Tosoian, Xiao, Samora, Chopra, Siddiqui, H. Zheng, Herron, Arivoli, Palapattu, Salami, Chan, Srivastava, Feng, Sanda, Wei.

Supervision: Tosoian, Morgan, Palapattu, Srivastava, Feng, Y. Zheng, Chinnaiyan.

Conflict of Interest Disclosures: Dr Tosoian reported personal fees from LynxDx and equity interest from LynxDx outside the submitted work; and has a patent for a novel multiplex urine test for high-grade prostate cancer pending. Dr Zhang reported personal fees from LynxDx outside the submitted work and has a patent for a novel multiplex urine test for high-grade prostate cancer pending. Dr Xiao reported grants from Prostate Cancer Foundation as well as personal fees from LynxDx during the conduct of the study; and has a patent for a novel multiplex urine test for high-grade prostate cancer pending. Dr Niknafs reported personal fees from LynxDx during the conduct of the study; personal fees from LynxDx outside the submitted work; and has a patent for use of some biomarkers as diagnostic tools issued. Dr Trock reported personal fees from Artera during the conduct of the study as well as personal fees from Myriad Genetics outside the submitted work. Dr Salami reported personal fees from Bayer and NRichDx during the conduct of the study. Dr Tomlins reported grants and personal fees from Astellas as well as equity interest from Strata Oncology outside the submitted work; and has a patent for ETS gene fusions in prostate cancer issued and licensed to LynxDx. Dr Sokoll reported grants from the National Institutes of Health during the conduct of the study. Dr Feng reported grants from the National Cancer Institute during the conduct of the study. Dr Chinnaiyan reported grants from the National Institutes of Health/National Cancer Institute, Prostate Cancer Foundation, and Howard Hughes Medical Institute; nonfinancial support from the American Cancer Society during the conduct of the study; and equity interest from LynxDx outside the submitted work; and has a patent for a novel multiplex urine test for high-grade prostate cancer pending. No other disclosures were reported.

Funding/Support: This work was funded by the Michigan-Vanderbilt Early Detection Research Network Biomarker Characterization Center (grant U2C CA271854) and the Early Detection Research Network Data Management and Coordinating Center (grant U24 CA086368). The Early Detection Research Network Data Management and Coordinating Center carried out analyses on the blinded validation cohort. Other sources of funding not involved in the design and conduct of the study included the Michigan Prostate Specialized Program of Research Excellence (grant P50 CA186786), National Cancer Institute Outstanding Investigator Award (Dr Chinnaiyan; grant R35 CA231996), Johns Hopkins University Biomarker Reference Laboratory (grant U24 CA115102), National Cancer Institute Early Detection Research Network Clinical Validation Center (grant U01 CA113913), Prostate Cancer Foundation Young Investigator Award (Drs Tosoian and Xiao), Prostate Cancer Foundation, Howard Hughes Medical Institute (Dr Chinnaiyan), and the American Cancer Society (Dr Chinnaiyan).

Role of the Funder/Sponsor: The Early Detection Research Network Data Management and Coordinating Center members had access to the blinded validation cohort analysis; the other funders had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.

Group Information: Members of the EDRN-PCA3 Study Group appear in Supplement 4.

Meeting Presentation: These data were presented in abstract form at the American Urological Association 2023 Annual Meeting; April 28, 2023; Chicago, IL.

Previous Posting: This article was posted as a preprint on medRxiv.org.

Data Sharing Statement: See Supplement 5.

Additional Contributions: We thank Stephanie Miner, PhD (Michigan Center for Translational Pathology, University of Michigan, Ann Arbor), for her help in the editing and file preparation of this study. Dr Miner was not compensated for her work.

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urinetest met 18 genen, 2 genentest, PSA meting, prostaatkanker hooggradig, biopsie, voorspelling, MSP2 test


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