Risk stratification in men with a negative prostate biopsy: an interim analysis of a prospective cohort study.
Adult
Aged
Digital Rectal Examination
Follow-Up Studies
Humans
Image-Guided Biopsy
Male
Medical History Taking
Middle Aged
Multiparametric Magnetic Resonance Imaging
Neoplasm Grading
Polymorphism, Single Nucleotide
Prospective Studies
Prostate
/ pathology
Prostate-Specific Antigen
/ blood
Prostatic Neoplasms
/ blood
Risk Assessment
/ methods
Risk Factors
diagnosis
genetic testing
prostate cancer
risk stratification
single-nucleotide polymorphism
triage
Journal
BJU international
ISSN: 1464-410X
Titre abrégé: BJU Int
Pays: England
ID NLM: 100886721
Informations de publication
Date de publication:
12 2021
12 2021
Historique:
pubmed:
9
5
2021
medline:
4
1
2022
entrez:
8
5
2021
Statut:
ppublish
Résumé
To investigate whether a risk score for prostate cancer (PCa) lifetime risk can be used to optimise triaging of patients with a negative prostate biopsy, but under sustained suspicion of PCa. In this prospective clinical study, we included, and risk scored patients who had a PCa-negative transrectal ultrasonography (TRUS)-guided prostate biopsy, but elevated prostate-specific antigen (PSA), a suspicious prostate digital rectal examination and/or a positive family history (FH) of PCa. The risk score estimated individual lifetime risk of PCa, based on a polygenic risk score (33 single nucleotide polymorphisms), age, and FH of PCa. Patients were followed, under urological supervision, for up to 4 years with annual controls, always including PSA measurements. Multiparametric magnetic resonance imaging (mpMRI) and/or prostate biopsy was performed at selected annual controls depending on risk score and at the urologist's/patient's discretion, which means that the follow-up differed based on the risk score. We included 429 patients. After risk scoring, 376/429 (88%) patients were allocated to a normal-risk group (<30% PCa lifetime risk) and 53/429 (12%) to a high-risk group (≥30% PCa lifetime risk). The high-risk group had significantly different follow-up, with more biopsy and mpMRI sessions compared to the normal-risk group. PCa was detected in 89/429 (21%) patients, with 67/376 (18%) patients diagnosed in the normal-risk group and 22/53 (42%) in the high-risk group. There was no statistically significant difference in the cumulative incidence of PCa between the normal-risk group and the high-risk group after 4 years of follow-up. Currently, 67/429 (16%) patients are still being followed in this ongoing study. In a 4-year perspective, our PCa lifetime risk score did not demonstrate significant prognostic value for triaging patients, with a negative TRUS-guided biopsy and sustained suspicion of PCa.
Substances chimiques
Prostate-Specific Antigen
EC 3.4.21.77
Types de publication
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
702-712Informations de copyright
© 2021 The Authors BJU International © 2021 BJU International.
Références
Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin 2018; 68: 394-424
Wilt TJ, Brawer MK, Jones KM et al. Radical prostatectomy versus observation for localized prostate cancer. N Engl J Med 2012; 367: 203-13
DaProCa - Kliniske retningslinjer for prostata cancer, 2020. Available at: https://ducg.dk/daproca-prostatacancer/kliniske-retningslinjer/. Accessed May 2021
Velonas V, Woo H, Remedios C, Assinder S. Current status of biomarkers for prostate cancer. Int J Mol Sci 2013; 14: 11034-60
Barry MJ, Simmons LH. Prevention of prostate cancer morbidity and mortality: primary prevention and early detection. Med Clin North Am 2017; 101: 787-806
Mistry K, Cable G. Meta-analysis of prostate-specific antigen and digital rectal examination as screening tests for prostate carcinoma. J Am Board Fam Pract 2003; 16: 95-101
Heijnsdijk EAM, Wever EM, Auvinen A et al. Quality-of-life effects of prostate-specific antigen screening. N Engl J Med 2012; 367: 595-605
Jue JS, Barboza MP, Prakash NS et al. Re-examining prostate-specific antigen (PSA) density: defining the optimal PSA range and patients for using PSA density to predict prostate cancer using extended template biopsy. Urology 2017; 105: 123-8
Nordstrom T, Akre O, Aly M, Gronberg H, Eklund M. Prostate-specific antigen (PSA) density in the diagnostic algorithm of prostate cancer. Prostate Cancer Prostatic Dis 2018; 21: 57-63
Yusim I, Krenawi M, Mazor E, Novack V, Mabjeesh NJ. The use of prostate specific antigen density to predict clinically significant prostate cancer. Sci Rep 2020; 10: 20015
Feng ZJ, Xue C, Wen JM, Li Y, Wang M, Zhang N. PSAD test in the diagnosis of prostate cancer: a meta-analysis. Clin Lab 2017; 63: 147-55
Yacoub JH, Verma S, Moulton JS, Eggener S, Aytekin O. Imaging-guided prostate biopsy: conventional and emerging techniques. Radiographics 2012; 32: 819-37
Djavan B, Waldert M, Zlotta A et al. Safety and morbidity of first and repeat transrectal ultrasound guided prostate needle biopsies: results of a prospective European prostate cancer detection study. J Urol 2001; 166: 856-60
de Jesus CM, Correa LA, Padovani CR. Complications and risk factors in transrectal ultrasound-guided prostate biopsies. Sao Paulo Med J 2006; 124: 198-202
Hambrock T, Somford DM, Hoeks C et al. Magnetic resonance imaging guided prostate biopsy in men with repeat negative biopsies and increased prostate specific antigen. J Urol 2010; 183: 520-7
Hoeks CM, Schouten MG, Bomers JG et al. Three-Tesla magnetic resonance-guided prostate biopsy in men with increased prostate-specific antigen and repeated, negative, random, systematic, transrectal ultrasound biopsies: detection of clinically significant prostate cancers. Eur Urol 2012; 62: 902-9
National Institute for Health and Care Excellence (NICE). NICE guidance - prostate cancer: diagnosis and management: © NICE (2019) Prostate cancer: diagnosis and management. BJU Int 2019; 124: 9-26
Neal DE. PSA testing for prostate cancer improves survival-but can we do better? Lancet Oncol 2010; 11: 702-3
Basch E, Oliver TK, Vickers A et al. Screening for prostate cancer with prostate-specific antigen testing: American Society of Clinical Oncology Provisional Clinical Opinion. J Clin Oncol 2012; 30: 3020-5
Benafif S, Eeles R. Genetic predisposition to prostate cancer. Br Med Bull 2016; 120: 75-89
Heidegger I, Tsaur I, Borgmann H et al. Hereditary prostate cancer - primetime for genetic testing? Cancer Treat Rev 2019; 81: 101927
Lichtenstein P, Holm NV, Verkasalo PK et al. Environmental and heritable factors in the causation of cancer-analyses of cohorts of twins from Sweden, Denmark, and Finland. N Engl J Med 2000; 343: 78-85
Bratt O. What should a urologist know about hereditary predisposition to prostate cancer? BJU Int 2007; 99: 743-8
Schumacher FR, Al Olama AA, Berndt SI et al. Association analyses of more than 140,000 men identify 63 new prostate cancer susceptibility loci. Nat Genet 2018; 50: 928-36
Eeles R, Goh C, Castro E et al. The genetic epidemiology of prostate cancer and its clinical implications. Nat Rev Urol 2014; 11: 18-31
Isaacs WB, Xu J. Current progress and questions in germline genetics of prostate cancer. Asian J Urol 2019; 6: 3-9
Fredsøe J, Koetsenruyter J, Vedsted P et al. The effect of assessing genetic risk of prostate cancer on the use of PSA tests in primary care: a cluster randomized controlled trial. PLoS Med 2020; 17: e1003033
Storebjerg TM, Høyer S, Kirkegaard P et al. Prevalence of the HOXB13 G84E mutation in Danish men undergoing radical prostatectomy and its correlations with prostate cancer risk and aggressiveness. BJU Int 2016; 118: 646-53
Kote-Jarai Z, Olama AA, Giles GG et al. Seven prostate cancer susceptibility loci identified by a multi-stage genome-wide association study. Nat Genet 2011; 43: 785-91
Epstein JI, Egevad L, Amin MB, Delahunt B, Srigley JR, Humphrey PA. The 2014 International Society of Urological Pathology (ISUP) consensus conference on Gleason grading of prostatic carcinoma. Am J Surg Pathol 2016; 40: 244-52
Turkbey B, Rosenkrantz AB, Haider MA et al. Prostate imaging reporting and data system version 2.1: 2019 update of prostate imaging reporting and data system version 2. Eur Urol 2019; 76: 340-51
Weinreb JC, Barentsz JO, Choyke PL et al. PI-RADS prostate imaging - reporting and data system: 2015, version 2. Eur Urol 2016; 69: 16-40
Johansen MN, Lundbye-Christensen S, Larsen JM, Parner ET. Regression models for interval censored data using parametric pseudo-observations. BMC Med Res Methodol 2021; 21: 36
Valerio M, Anele C, Charman SC et al. Transperineal template prostate-mapping biopsies: an evaluation of different protocols in the detection of clinically significant prostate cancer. BJU Int 2016; 118: 384-90
Crawford ED, Wilson SS, Torkko KC et al. Clinical staging of prostate cancer: a computer-simulated study of transperineal prostate biopsy. BJU Int 2005; 96: 999-1004
Hu Y, Ahmed HU, Carter T et al. A biopsy simulation study to assess the accuracy of several transrectal ultrasonography (TRUS)-biopsy strategies compared with template prostate mapping biopsies in patients who have undergone radical prostatectomy. BJU Int 2012; 110: 812-20
Kasivisvanathan V, Rannikko AS, Borghi M et al. MRI-targeted or standard biopsy for prostate-cancer diagnosis. N Engl J Med 2018; 378: 1767-77
Ahmed HU, El-Shater Bosaily A, Brown LC et al. Diagnostic accuracy of multi-parametric MRI and TRUS biopsy in prostate cancer (PROMIS): a paired validating confirmatory study. Lancet 2017; 389: 815-22
Kader AK, Sun J, Reck BH et al. Potential impact of adding genetic markers to clinical parameters in predicting prostate biopsy outcomes in men following an initial negative biopsy: findings from the REDUCE trial. Eur Urol 2012; 62: 953-61
Al Olama AA, Kote-Jarai Z, Berndt SI et al. A meta-analysis of 87,040 individuals identifies 23 new susceptibility loci for prostate cancer. Nat Genet 2014; 46: 1103-9
Klemann N, Røder MA, Helgstrand JT et al. Risk of prostate cancer diagnosis and mortality in men with a benign initial transrectal ultrasound-guided biopsy set: a population-based study. Lancet Oncol 2017; 18: 221-9
Gann PH, Hennekens CH, Stampfer MJ. A prospective evaluation of plasma prostate-specific antigen for detection of prostatic cancer. JAMA 1995; 273: 289-94
Kote-Jarai Z, Olama AA, Giles GG et al. Seven prostate cancer susceptibility loci identified by a multi-stage genome-wide association study. Nat Genet 2011; 43: 785-91
Seibert TM, Fan CC, Wang Y et al. Polygenic hazard score to guide screening for aggressive prostate cancer: development and validation in large scale cohorts. BMJ 2018; 360: j5757
Eklund M, Nordström T, Aly M et al. The Stockholm-3 (STHLM3) model can improve prostate cancer diagnostics in men aged 50-69 yr compared with current prostate cancer testing. Eur Urol Focus 2018; 4: 707-10
Grönberg H, Adolfsson J, Aly M et al. Prostate cancer screening in men aged 50-69 years (STHLM3): a prospective population-based diagnostic study. Lancet Oncol 2015; 16: 1667-76
Viste E, Vinje CA, Lid TG et al. Effects of replacing PSA with Stockholm3 for diagnosis of clinically significant prostate cancer in a healthcare system - the Stavanger experience. Scand J Prim Health Care 2020; 38: 315-22