MRI Prostate for Chinese Men Being Screened for Prostate Cancer

NCT03891732 | Active Not Recruiting

• 1 other identifier: CRE 2018.495
• Study Type: observational
• Target: 690
• Locations: 1 country
• Sites: 2

Brief Summary

Under the prostate cancer screening protocol of the project 'Prevention of Obesity-related Cancers', men with elevated PSA with higher prostate cancer risk (PSA 4-10 ng/mL with high Prostate Health Index (PHI) ≥35, or PSA\>10 ng/mL) will be offered a prostate biopsy. In the current study, we would like to offer all screened men with elevated PSA in the range of 4-50 ng/mL a biparametric non-contrast MRI prostate (screening protocol) for any suspicious lesion in the prostate. If there is MRI lesion seen, additional targeted biopsies can be performed on top of the standard systematic prostate biopsies. It has been shown in a clinical Caucasian cohort that doing MRI-targeted biopsies resulted in improved detection of clinically significant prostate cancer compared with standard systematic biopsies. In this study investigators would like to investigate the benefits of adding MRI prostate and MRI-targeted biopsy in the diagnostic pathway for prostate cancer in a screened cohort of Chinese men at risk of prostate cancer.

Conditions

Prostate Cancer; PSA; MRI

Keywords

Prostate cancer; PSA; MRI; Biopsy

Outcome Measures

Primary Outcomes (2)

• In men with higher risk of prostate cancer, the proportion of men diagnosed with clinically significant prostate cancers on MRI pathway compared with standard screening pathway.

  In men with higher risk of prostate cancer (PSA 10-50 ng/mL, or PSA 4-10 AND Prostate Health Index ≥35), the proportion of men diagnosed with clinically significant prostate cancers on MRI pathway compared with standard screening pathway.

  Baseline (only one-time point)

• In men with lower risk of prostate cancer the proportion of men diagnosed with clinically significant prostate cancers on MRI pathway compared with standard screening pathway.

  In men with lower risk of prostate cancer (PSA 4-10 ng/mL AND Prostate Health Index \<35), the proportion of men diagnosed with clinically significant prostate cancers on MRI pathway compared with standard screening pathway.

  Baseline (only one-time point)

Secondary Outcomes (4)

• Gleason ≥4 cancer AND Maximal cancer core length ≥6mm

  Baseline (only one-time point)

• The number of MRI needed to detect one extra clinically significant prostate cancer compared to standard screening pathway

  Baseline (only one-time point)

• The proportion of men that a biopsy can be avoided by using MRI in higher and lower risk groups

  Baseline (only one-time point)

• In men with MRI suspicious lesion (PI-RADS 3 or above), clinically significant prostate cancer diagnosed on Systematic biopsy cores versus targeted biopsy cores

  Baseline (only one-time point)

Study Arms (2)

MRI pathway

Plain biparametric MRI prostate applied to men with elevated PSA, on top of standard screening pathway using PSA and Prostate Health Index

Diagnostic Test: MRI prostate

Standard screening pathway

Intervention: Using blood tests PSA and Prostate Health Index to screen men at risk of prostate cancer

Interventions

MRI prostate DIAGNOSTIC_TEST

plain biparametric MRI prostate

MRI pathway

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be recruited form the the project 'Prevention of Obesity-related Cancers". 5000 Chinese men between age 50 and 75 will be screened for prostate cancer with the blood test PSA.

You may qualify if:

• Men being screened for prostate cancer in the project 'Prevention of Obesity-related Cancers'
• Age 50-75
• Screening naïve, defined as no blood taking for PSA within past 5 years AND no prostate biopsy within past 5 years
• PSA 4-50 ng/mL
• Agree for non-contrast MRI scanning of prostate

You may not qualify if:

• Men who are contraindicated for MRI( Pacemaker in-situ, Metallic implants which are not MRI-compatible, or Claustrophobia)
• Prior history of prostate cancer

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (2)

North District Hospital

Hong Kong, Hong Kong

Location

Prince of Wales Hospital, Chinese University of Hong Kong

Hong Kong, Hong Kong

Location

Related Publications (13)

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  PMID: 25080928 BACKGROUND

• Schroder FH, Hugosson J, Roobol MJ, Tammela TL, Ciatto S, Nelen V, Kwiatkowski M, Lujan M, Lilja H, Zappa M, Denis LJ, Recker F, Berenguer A, Maattanen L, Bangma CH, Aus G, Villers A, Rebillard X, van der Kwast T, Blijenberg BG, Moss SM, de Koning HJ, Auvinen A; ERSPC Investigators. Screening and prostate-cancer mortality in a randomized European study. N Engl J Med. 2009 Mar 26;360(13):1320-8. doi: 10.1056/NEJMoa0810084. Epub 2009 Mar 18.

  PMID: 19297566 BACKGROUND

• Braillon A, Dubois G. Re: Fritz H. Schroder, Jonas Hugosson, Sigrid Carlsson, et al. Screening for prostate cancer decreases the risk of developing metastatic disease: findings from the European Randomized Study of Screening for Prostate Cancer (ERSPC). Eur urol 2012;62:745-52. Eur Urol. 2012 Nov;62(5):e89; author reply e90-1. doi: 10.1016/j.eururo.2012.07.031. Epub 2012 Jul 25. No abstract available.

  PMID: 22858456 BACKGROUND

• Schroder FH, Hugosson J, Roobol MJ, Tammela TL, Zappa M, Nelen V, Kwiatkowski M, Lujan M, Maattanen L, Lilja H, Denis LJ, Recker F, Paez A, Bangma CH, Carlsson S, Puliti D, Villers A, Rebillard X, Hakama M, Stenman UH, Kujala P, Taari K, Aus G, Huber A, van der Kwast TH, van Schaik RH, de Koning HJ, Moss SM, Auvinen A; ERSPC Investigators. Screening and prostate cancer mortality: results of the European Randomised Study of Screening for Prostate Cancer (ERSPC) at 13 years of follow-up. Lancet. 2014 Dec 6;384(9959):2027-35. doi: 10.1016/S0140-6736(14)60525-0. Epub 2014 Aug 6.

  PMID: 25108889 BACKGROUND

• 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.

  PMID: 27349564 BACKGROUND

• Ahmed HU, El-Shater Bosaily A, Brown LC, Gabe R, Kaplan R, Parmar MK, Collaco-Moraes Y, Ward K, Hindley RG, Freeman A, Kirkham AP, Oldroyd R, Parker C, Emberton M; PROMIS study group. Diagnostic accuracy of multi-parametric MRI and TRUS biopsy in prostate cancer (PROMIS): a paired validating confirmatory study. Lancet. 2017 Feb 25;389(10071):815-822. doi: 10.1016/S0140-6736(16)32401-1. Epub 2017 Jan 20.

  PMID: 28110982 BACKGROUND

• Alberts AR, Roobol MJ, Verbeek JFM, Schoots IG, Chiu PK, Osses DF, Tijsterman JD, Beerlage HP, Mannaerts CK, Schimmoller L, Albers P, Arsov C. Prediction of High-grade Prostate Cancer Following Multiparametric Magnetic Resonance Imaging: Improving the Rotterdam European Randomized Study of Screening for Prostate Cancer Risk Calculators. Eur Urol. 2019 Feb;75(2):310-318. doi: 10.1016/j.eururo.2018.07.031. Epub 2018 Aug 3.

  PMID: 30082150 BACKGROUND

• Vickers AJ, Cronin AM, Roobol MJ, Hugosson J, Jones JS, Kattan MW, Klein E, Hamdy F, Neal D, Donovan J, Parekh DJ, Ankerst D, Bartsch G, Klocker H, Horninger W, Benchikh A, Salama G, Villers A, Freedland SJ, Moreira DM, Schroder FH, Lilja H. The relationship between prostate-specific antigen and prostate cancer risk: the Prostate Biopsy Collaborative Group. Clin Cancer Res. 2010 Sep 1;16(17):4374-81. doi: 10.1158/1078-0432.CCR-10-1328. Epub 2010 Aug 24.

  PMID: 20736330 BACKGROUND

• 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.

  PMID: 27617315 BACKGROUND

• Chen R, Ren S; Chinese Prostate Cancer Consortium; Yiu MK, Fai NC, Cheng WS, Ian LH, Naito S, Matsuda T, Kehinde E, Kural A, Chiu JY, Umbas R, Wei Q, Shi X, Zhou L, Huang J, Huang Y, Xie L, Ma L, Yin C, Xu D, Xu K, Ye Z, Liu C, Ye D, Gao X, Fu Q, Hou J, Yuan J, He D, Pan T, Ding Q, Jin F, Shi B, Wang G, Liu X, Wang D, Shen Z, Kong X, Xu W, Deng Y, Xia H, Cohen AN, Gao X, Xu C, Sun Y. Prostate cancer in Asia: A collaborative report. Asian J Urol. 2014 Oct;1(1):15-29. doi: 10.1016/j.ajur.2014.08.007. Epub 2015 Apr 16.

  PMID: 29511634 BACKGROUND

• Weinreb JC, Barentsz JO, Choyke PL, Cornud F, Haider MA, Macura KJ, Margolis D, Schnall MD, Shtern F, Tempany CM, Thoeny HC, Verma S. PI-RADS Prostate Imaging - Reporting and Data System: 2015, Version 2. Eur Urol. 2016 Jan;69(1):16-40. doi: 10.1016/j.eururo.2015.08.052. Epub 2015 Oct 1.

  PMID: 26427566 BACKGROUND

• 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.

  PMID: 29552975 BACKGROUND

• Woo S, Suh CH, Kim SY, Cho JY, Kim SH, Moon MH. Head-to-Head Comparison Between Biparametric and Multiparametric MRI for the Diagnosis of Prostate Cancer: A Systematic Review and Meta-Analysis. AJR Am J Roentgenol. 2018 Nov;211(5):W226-W241. doi: 10.2214/AJR.18.19880. Epub 2018 Sep 21.

  PMID: 30240296 BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Peter Ka-Fung CHIU, FRCP, PhD

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 29, 2019
• First Posted: March 27, 2019
• Study Start: January 19, 2019
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: November 22, 2024

Record last verified: 2024-11

Locations

HK (2)