Artificial Intelligence (AI)-Assisted Risk-based Prostate Cancer Detection

Prostate Cancer Clinical Trial

Official title:

Artificial Intelligence (AI)-Assisted Risk-based Prostate Cancer Detection: A Synergy of Novel Biomarkers, Advanced Imaging, and Robotic-assisted Diagnosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05443412
• Other study ID #: CRE 2022.245
• Status: Recruiting
• Start date: August 1, 2023
• Est. completion date: October 30, 2026

Study information

• Verified date: January 2024
• Source: Chinese University of Hong Kong
• Contact: Peter Ka-Fung CHIU, FRCS, PhD
• Phone: 35052625
• Email: peterchiu[@]surgery.cuhk.edu.hk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a prospective clinical study recruiting 510 men at risk of PCa to undergo urine, blood, AI-assisted ultrasound and AI-assisted MRI investigations to stratify risk of clinically significant PCa (csPCa). (sample size calculation in section 5)

Description:

All recruited patients will undergo investigations including urine for spermine, blood for miRNA, TRUS, and MRI prostate. Patients with high suspicion of csPCa in any one step (urine, blood, ultrasound, OR MRI) will be offered an image-guided prostate biopsy. This will be followed by machine learning techniques to find the best combination in predicting csPCa.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 510
• Est. completion date: October 30, 2026
• Est. primary completion date: July 31, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Men =18 years of age
• Clinical suspicion of prostate cancer
• Serum Prostate-specific antigen (PSA) 4-20 ng/mL
• Digital rectal examination = cT2 (organ confined cancer)
• Able to provide written informed consent

Exclusion Criteria:

• Prior prostate biopsy
• Past or current history of prostate cancer
• Contraindicated to undergo plain MRI scan (e.g. pacemaker in-situ, claustrophobia)
• Contraindicated to transperineal prostate biopsy: active urinary tract infection, fail TRUS probe insertion or lithotomy position, uncorrectable coagulopathy, antiplatelet or anticoagulant which cannot be stopped

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Diagnostic Test:
• Diagnostic test for prostate cancer
All recruited patients will undergo investigations including urine for spermine, blood for miRNA, TRUS, and MRI prostate. Patients with high suspicion of Clinically significant prostate cancer in any one step (urine, blood, ultrasound, OR MRI) will be offered an image-guided prostate biopsy.

Locations

Country	Name	City	State
Hong Kong	Prince of Wales Hospital, Chinese University of Hong Kong	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

References & Publications (24)

Chiu PK, Fung YH, Teoh JY, Chan CH, Lo KL, Li KM, Tse RT, Leung CH, Wong YP, Roobol MJ, Wong KL, Ng CF. Urine spermine and multivariable Spermine Risk Score predict high-grade prostate cancer. Prostate Cancer Prostatic Dis. 2021 Jun;24(2):542-548. doi: 10.1038/s41391-020-00312-1. Epub 2021 Jan 6. — View Citation

Chiu PK, Ng CF, Semjonow A, Zhu Y, Vincendeau S, Houlgatte A, Lazzeri M, Guazzoni G, Stephan C, Haese A, Bruijne I, Teoh JY, Leung CH, Casale P, Chiang CH, Tan LG, Chiong E, Huang CY, Wu HC, Nieboer D, Ye DW, Bangma CH, Roobol MJ. A Multicentre Evaluation of the Role of the Prostate Health Index (PHI) in Regions with Differing Prevalence of Prostate Cancer: Adjustment of PHI Reference Ranges is Needed for European and Asian Settings. Eur Urol. 2019 Apr;75(4):558-561. doi: 10.1016/j.eururo.2018.10.047. Epub 2018 Nov 2. — View Citation

Chiu PK, Roobol MJ, Nieboer D, Teoh JY, Yuen SK, Hou SM, Yiu MK, Ng CF. Adaptation and external validation of the European randomised study of screening for prostate cancer risk calculator for the Chinese population. Prostate Cancer Prostatic Dis. 2017 Mar;20(1):99-104. doi: 10.1038/pcan.2016.57. Epub 2016 Nov 29. — View Citation

Chiu PK, Roobol MJ, Teoh JY, Lee WM, Yip SY, Hou SM, Bangma CH, Ng CF. Prostate health index (PHI) and prostate-specific antigen (PSA) predictive models for prostate cancer in the Chinese population and the role of digital rectal examination-estimated prostate volume. Int Urol Nephrol. 2016 Oct;48(10):1631-7. doi: 10.1007/s11255-016-1350-8. Epub 2016 Jun 27. — View Citation

Chiu PK, Shen X, Wang G, Ho CL, Leung CH, Ng CF, Choi KS, Teoh JY. Enhancement of prostate cancer diagnosis by machine learning techniques: an algorithm development and validation study. Prostate Cancer Prostatic Dis. 2022 Apr;25(4):672-676. doi: 10.1038/s41391-021-00429-x. Epub 2021 Jul 15. — View Citation

Chiu PK, Teoh JY, Chan SY, Chu PS, Man CW, Hou SM, Ng CF. Role of PSA density in diagnosis of prostate cancer in obese men. Int Urol Nephrol. 2014 Dec;46(12):2251-4. doi: 10.1007/s11255-014-0826-7. Epub 2014 Sep 9. — View Citation

Chiu PK, Teoh JY, Lee WM, Yee CH, Chan ES, Hou SM, Ng CF. Extended use of Prostate Health Index and percentage of [-2]pro-prostate-specific antigen in Chinese men with prostate specific antigen 10-20 ng/mL and normal digital rectal examination. Investig Clin Urol. 2016 Sep;57(5):336-42. doi: 10.4111/icu.2016.57.5.336. Epub 2016 Aug 31. — View Citation

de la Taille A, Irani J, Graefen M, Chun F, de Reijke T, Kil P, Gontero P, Mottaz A, Haese A. Clinical evaluation of the PCA3 assay in guiding initial biopsy decisions. J Urol. 2011 Jun;185(6):2119-25. doi: 10.1016/j.juro.2011.01.075. Epub 2011 Apr 15. — View Citation

Desai MM, Cacciamani GE, Gill K, Zhang J, Liu L, Abreu A, Gill IS. Trends in Incidence of Metastatic Prostate Cancer in the US. JAMA Netw Open. 2022 Mar 1;5(3):e222246. doi: 10.1001/jamanetworkopen.2022.2246. — View Citation

Grey ADR, Scott R, Shah B, Acher P, Liyanage S, Pavlou M, Omar R, Chinegwundoh F, Patki P, Shah TT, Hamid S, Ghei M, Gilbert K, Campbell D, Brew-Graves C, Arumainayagam N, Chapman A, McLeavy L, Karatziou A, Alsaadi Z, Collins T, Freeman A, Eldred-Evans D, Bertoncelli-Tanaka M, Tam H, Ramachandran N, Madaan S, Winkler M, Arya M, Emberton M, Ahmed HU. Multiparametric ultrasound versus multiparametric MRI to diagnose prostate cancer (CADMUS): a prospective, multicentre, paired-cohort, confirmatory study. Lancet Oncol. 2022 Mar;23(3):428-438. doi: 10.1016/S1470-2045(22)00016-X. — View Citation

Hugosson J, Roobol MJ, Mansson M, Tammela TLJ, Zappa M, Nelen V, Kwiatkowski M, Lujan M, Carlsson SV, Talala KM, Lilja H, Denis LJ, Recker F, Paez A, Puliti D, Villers A, Rebillard X, Kilpelainen TP, Stenman UH, Godtman RA, Stinesen Kollberg K, Moss SM, Kujala P, Taari K, Huber A, van der Kwast T, Heijnsdijk EA, Bangma C, De Koning HJ, Schroder FH, Auvinen A; ERSPC investigators. A 16-yr Follow-up of the European Randomized study of Screening for Prostate Cancer. Eur Urol. 2019 Jul;76(1):43-51. doi: 10.1016/j.eururo.2019.02.009. Epub 2019 Feb 26. — View Citation

Kasivisvanathan V, Rannikko AS, Borghi M, Panebianco V, Mynderse LA, Vaarala MH, Briganti A, Budaus L, Hellawell G, Hindley RG, Roobol MJ, Eggener S, Ghei M, Villers A, Bladou F, Villeirs GM, Virdi J, Boxler S, Robert G, Singh PB, Venderink W, Hadaschik BA, Ruffion A, Hu JC, Margolis D, Crouzet S, Klotz L, Taneja SS, Pinto P, Gill I, Allen C, Giganti F, Freeman A, Morris S, Punwani S, Williams NR, Brew-Graves C, Deeks J, Takwoingi Y, Emberton M, Moore CM; PRECISION Study Group Collaborators. MRI-Targeted or Standard Biopsy for Prostate-Cancer Diagnosis. N Engl J Med. 2018 May 10;378(19):1767-1777. doi: 10.1056/NEJMoa1801993. Epub 2018 Mar 18. — View Citation

Liu HP, Lai HM, Guo Z. Prostate cancer early diagnosis: circulating microRNA pairs potentially beyond single microRNAs upon 1231 serum samples. Brief Bioinform. 2021 May 20;22(3):bbaa111. doi: 10.1093/bib/bbaa111. — View Citation

Liu Q, Dou Q, Yu L, Heng PA. MS-Net: Multi-Site Network for Improving Prostate Segmentation With Heterogeneous MRI Data. IEEE Trans Med Imaging. 2020 Sep;39(9):2713-2724. doi: 10.1109/TMI.2020.2974574. Epub 2020 Feb 17. — View Citation

Mottet N, van den Bergh RCN, Briers E, Van den Broeck T, Cumberbatch MG, De Santis M, Fanti S, Fossati N, Gandaglia G, Gillessen S, Grivas N, Grummet J, Henry AM, van der Kwast TH, Lam TB, Lardas M, Liew M, Mason MD, Moris L, Oprea-Lager DE, van der Poel HG, Rouviere O, Schoots IG, Tilki D, Wiegel T, Willemse PM, Cornford P. EAU-EANM-ESTRO-ESUR-SIOG Guidelines on Prostate Cancer-2020 Update. Part 1: Screening, Diagnosis, and Local Treatment with Curative Intent. Eur Urol. 2021 Feb;79(2):243-262. doi: 10.1016/j.eururo.2020.09.042. Epub 2020 Nov 7. — View Citation

Ng CF, Chiu PK, Lam NY, Lam HC, Lee KW, Hou SS. The Prostate Health Index in predicting initial prostate biopsy outcomes in Asian men with prostate-specific antigen levels of 4-10 ng/mL. Int Urol Nephrol. 2014 Apr;46(4):711-7. doi: 10.1007/s11255-013-0582-0. Epub 2013 Oct 18. — View Citation

Ng CF, Yeung R, Chiu PK, Lam NY, Chow J, Chan B. The role of urine prostate cancer antigen 3 mRNA levels in the diagnosis of prostate cancer among Hong Kong Chinese patients. Hong Kong Med J. 2012 Dec;18(6):459-65. — View Citation

Rawla P. Epidemiology of Prostate Cancer. World J Oncol. 2019 Apr;10(2):63-89. doi: 10.14740/wjon1191. Epub 2019 Apr 20. — View Citation

Shen X, Wang G, Kwan RY, Choi KS. Using Dual Neural Network Architecture to Detect the Risk of Dementia With Community Health Data: Algorithm Development and Validation Study. JMIR Med Inform. 2020 Aug 31;8(8):e19870. doi: 10.2196/19870. — View Citation

Tsoi TH, Chan CF, Chan WL, Chiu KF, Wong WT, Ng CF, Wong KL. Urinary Polyamines: A Pilot Study on Their Roles as Prostate Cancer Detection Biomarkers. PLoS One. 2016 Sep 6;11(9):e0162217. doi: 10.1371/journal.pone.0162217. eCollection 2016. — View Citation

Tsoi TH, Gu YJ, Lo WS, Wong WT, Wong WT, Ng CF, Lee CS, Wong KL. Study of the Aggregation of DNA-Capped Gold Nanoparticles: A Smart and Flexible Aptasensor for Spermine Sensing. Chempluschem. 2017 May;82(5):802-809. doi: 10.1002/cplu.201700155. — View Citation

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Van Neste L, Hendriks RJ, Dijkstra S, Trooskens G, Cornel EB, Jannink SA, de Jong H, Hessels D, Smit FP, Melchers WJ, Leyten GH, de Reijke TM, Vergunst H, Kil P, Knipscheer BC, Hulsbergen-van de Kaa CA, Mulders PF, van Oort IM, Van Criekinge W, Schalken JA. Detection of High-grade Prostate Cancer Using a Urinary Molecular Biomarker-Based Risk Score. Eur Urol. 2016 Nov;70(5):740-748. doi: 10.1016/j.eururo.2016.04.012. Epub 2016 Apr 20. — View Citation

Wery M. [Malaria. Biologic diagnosis. Present status and the future]. Rev Prat. 1988 Jun 16;38(18):1159-63. No abstract available. French. — View Citation

* Note: There are 24 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnosis of clinically significant Prostate cancer (csPCa); • csPCa is diagnosis of ISUP Grade group =2 prostate cancer in at least 1 biopsy core	Assessed by by machine learning algorithms utilizing clinical parameters, novel biomarkers and AI-assisted imaging	Through study completion, an average of 1 year
Secondary	Diagnosis of any grade of prostate cancer	Assessed by prostate biopsy	Through study completion, an average of 1 year
Secondary	Proportion of men with diagnosis of clinically insignificant prostate cancer	Assessed by prostate biopsy	Through study completion, an average of 1 year
Secondary	Prostate biopsies that can be avoided	Assessed by using different machine learning algorithms	Through study completion, an average of 1 year
Secondary	The concordance of AI-assisted TRUS & MRI diagnosis and biopsy outcomes	Assessed by using different machine learning algorithms and prostate biopsy result	Through study completion, an average of 1 year