Utility of Biparametric MRI (Magnetic Resonance Imaging) as a Screening Tool for Prostate Cancer in a High-Risk Cohort

Prostate Cancer Clinical Trial

Official title:

Utility of Biparametric MRI (Magnetic Resonance Imaging) as a Screening Tool for Prostate Cancer in a High-Risk Cohort

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05384535
• Other study ID #: 21-1380
• Status: Recruiting
• Phase: N/A
• Start date: August 15, 2022
• Est. completion date: October 31, 2026

Study information

• Verified date: December 2023
• Source: Northwell Health
• Contact: Cynthia Knauer, RN
• Phone: 516-734-8500
• Email: urologyresearch[@]northwell.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To determine whether using bpMRI in subjects who are at high risk of developing prostate cancer in conjunction with PSA will improve prostate cancer screening protocols.

Description:

The Investigators propose a pilot study which utilizes bpMRI in conjunction with PSA in the early detection of clinically significant prostate cancer in a high-risk group. Our study would focus on these high-risk subjects between the ages of 40-55 with a normal PSA ranging from ≥1.0 to <2.5 ng/mL. bpMRI would be obtained in this group of subjects. If any suspicious lesions are found, the recommendation is to undergo MRI/US fusion biopsy. Subjects with negative bpMRI will be followed every year with serum PSA. Subjects with a positive bpMRI will have a prostate fusion and systematic biopsy performed. Those with a benign biopsy will be followed every year with serum PSA. Those who have a biopsy positive for cancer will be managed and followed according to the standard of care. All subjects will be followed for 5 years. Our hypothesis is that bpMRI in conjunction with above average PSA in a high-risk group will increase detection of clinically relevant prostate cancer and provide a useful addition to PSA screening.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: October 31, 2026
• Est. primary completion date: October 31, 2025
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years to 55 Years

Eligibility

Inclusion Criteria:

1. PSA between 1.0 and 2.5 ng/dL

2. High risk for prostate cancer, i.e. Black or they have a first degree relative with history of prostate cancer (father, brother) or specific genetic syndromes i.e. BRCA 1/2, HOX B13, Lynch syndrome, ATM, CHEK2

3. Patient is willing to participated in prostate cancer screening

4. Patient is capable of giving informed consent

Exclusion Criteria:

1. Nodularity or firmness of prostate on exam

2. Patient has undergone a prior biopsy or prostate surgery

3. Patient is taking 5-alpha reductase inhibitors to manage benign prostatic hyperplasia, as this can significantly alter PSA levels.

4. Patient has a history of UTI or prostatitis in the preceding 6 months, as this can significantly alter PSA levels.

5. Patient has a contraindication to MRI, these include but are not limited to pacemakers, neurostimulator devices, metal cardiac valves, certain tattoos, or foreign bodies

6. Participants that experience claustrophobia, anxiety and/or vertigo when moved inside the scanner

7. The participant cannot tolerate lying flat for the study duration

Related Conditions & MeSH terms

• Magnetic Resonance Imaging
• Population at Risk
• Prostate Cancer
• Prostatic Neoplasms

Intervention

Diagnostic Test:
• Bi-parametric MRI
When used for the evaluation of prostate cancer, MRI typically involves multiple sequences and typically includes typical T1 and T2 phases with the addition of diffusion weighted imaging and dynamic contrast enhanced imaging. In this study, we have decided to omit dynamic contrast enhanced imaging due to its decreased diagnostic yield relative to T2 and DWI and associated increased risk of contrast agents, this is a common approach for prostate cancer screening and is referred to as a bi-parametric MRI

Locations

Country	Name	City	State
United States	Cynthia Knauer	Lake Success	New York

Sponsors (1)

Lead Sponsor	Collaborator
Northwell Health

Country where clinical trial is conducted

United States, 

References & Publications (38)

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. — View Citation

Baquet CR, Horm JW, Gibbs T, Greenwald P. Socioeconomic factors and cancer incidence among blacks and whites. J Natl Cancer Inst. 1991 Apr 17;83(8):551-7. doi: 10.1093/jnci/83.8.551. — View Citation

Barocas DA, Penson DF. Racial variation in the pattern and quality of care for prostate cancer in the USA: mind the gap. BJU Int. 2010 Aug;106(3):322-8. doi: 10.1111/j.1464-410X.2010.09467.x. Epub 2010 Jun 14. — View Citation

Bass EJ, Pantovic A, Connor M, Gabe R, Padhani AR, Rockall A, Sokhi H, Tam H, Winkler M, Ahmed HU. A systematic review and meta-analysis of the diagnostic accuracy of biparametric prostate MRI for prostate cancer in men at risk. Prostate Cancer Prostatic Dis. 2021 Sep;24(3):596-611. doi: 10.1038/s41391-020-00298-w. Epub 2020 Nov 20. — View Citation

Belli P, Costantini M, Bufi E, Magistrelli A, La Torre G, Bonomo L. Diffusion-weighted imaging in breast lesion evaluation. Radiol Med. 2010 Feb;115(1):51-69. doi: 10.1007/s11547-009-0430-6. Epub 2009 Nov 9. English, Italian. — View Citation

Bratt O, Drevin L, Akre O, Garmo H, Stattin P. Family History and Probability of Prostate Cancer, Differentiated by Risk Category: A Nationwide Population-Based Study. J Natl Cancer Inst. 2016 Jul 10;108(10):djw110. doi: 10.1093/jnci/djw110. Print 2016 Oct. — View Citation

Brown LC, Ahmed HU, Faria R, El-Shater Bosaily A, Gabe R, Kaplan RS, Parmar M, Collaco-Moraes Y, Ward K, Hindley RG, Freeman A, Kirkham A, Oldroyd R, Parker C, Bott S, Burns-Cox N, Dudderidge T, Ghei M, Henderson A, Persad R, Rosario DJ, Shergill I, Winkler M, Soares M, Spackman E, Sculpher M, Emberton M. Multiparametric MRI to improve detection of prostate cancer compared with transrectal ultrasound-guided prostate biopsy alone: the PROMIS study. Health Technol Assess. 2018 Jul;22(39):1-176. doi: 10.3310/hta22390. — View Citation

Catalona WJ, Smith DS, Ratliff TL, Dodds KM, Coplen DE, Yuan JJ, Petros JA, Andriole GL. Measurement of prostate-specific antigen in serum as a screening test for prostate cancer. N Engl J Med. 1991 Apr 25;324(17):1156-61. doi: 10.1056/NEJM199104253241702. Erratum In: N Engl J Med 1991 Oct 31;325(18):1324. — View Citation

Chandarana H, Taouli B. Diffusion-weighted MRI and liver metastases. Magn Reson Imaging Clin N Am. 2010 Aug;18(3):451-64, x. doi: 10.1016/j.mric.2010.07.001. — View Citation

Drost FH, Osses DF, Nieboer D, Steyerberg EW, Bangma CH, Roobol MJ, Schoots IG. Prostate MRI, with or without MRI-targeted biopsy, and systematic biopsy for detecting prostate cancer. Cochrane Database Syst Rev. 2019 Apr 25;4(4):CD012663. doi: 10.1002/14651858.CD012663.pub2. — View Citation

Elwenspoek MMC, Sheppard AL, McInnes MDF, Merriel SWD, Rowe EWJ, Bryant RJ, Donovan JL, Whiting P. Comparison of Multiparametric Magnetic Resonance Imaging and Targeted Biopsy With Systematic Biopsy Alone for the Diagnosis of Prostate Cancer: A Systematic Review and Meta-analysis. JAMA Netw Open. 2019 Aug 2;2(8):e198427. doi: 10.1001/jamanetworkopen.2019.8427. — View Citation

Fleshner NE, O'Sullivan M, Fair WR. Prevalence and predictors of a positive repeat transrectal ultrasound guided needle biopsy of the prostate. J Urol. 1997 Aug;158(2):505-8; discussion 508-9. — View Citation

Hankey BF, Feuer EJ, Clegg LX, Hayes RB, Legler JM, Prorok PC, Ries LA, Merrill RM, Kaplan RS. Cancer surveillance series: interpreting trends in prostate cancer--part I: Evidence of the effects of screening in recent prostate cancer incidence, mortality, and survival rates. J Natl Cancer Inst. 1999 Jun 16;91(12):1017-24. doi: 10.1093/jnci/91.12.1017. — View Citation

Hoeks CM, Barentsz JO, Hambrock T, Yakar D, Somford DM, Heijmink SW, Scheenen TW, Vos PC, Huisman H, van Oort IM, Witjes JA, Heerschap A, Futterer JJ. Prostate cancer: multiparametric MR imaging for detection, localization, and staging. Radiology. 2011 Oct;261(1):46-66. doi: 10.1148/radiol.11091822. — View Citation

Hofbauer SL, Maxeiner A, Kittner B, Heckmann R, Reimann M, Wiemer L, Asbach P, Haas M, Penzkofer T, Stephan C, Friedersdorff F, Fuller F, Miller K, Cash H. Validation of Prostate Imaging Reporting and Data System Version 2 for the Detection of Prostate Cancer. J Urol. 2018 Oct;200(4):767-773. doi: 10.1016/j.juro.2018.05.003. Epub 2018 May 5. — View Citation

Hoffman RM, Gilliland FD, Eley JW, Harlan LC, Stephenson RA, Stanford JL, Albertson PC, Hamilton AS, Hunt WC, Potosky AL. Racial and ethnic differences in advanced-stage prostate cancer: the Prostate Cancer Outcomes Study. J Natl Cancer Inst. 2001 Mar 7;93(5):388-95. doi: 10.1093/jnci/93.5.388. — View Citation

Hu Y, Ahmed HU, Carter T, Arumainayagam N, Lecornet E, Barzell W, Freeman A, Nevoux P, Hawkes DJ, Villers A, Emberton M, Barratt DC. 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 Sep;110(6):812-20. doi: 10.1111/j.1464-410X.2012.10933.x. Epub 2012 Mar 6. — View Citation

Jambor I, Verho J, Ettala O, Knaapila J, Taimen P, Syvanen KT, Kiviniemi A, Kahkonen E, Perez IM, Seppanen M, Rannikko A, Oksanen O, Riikonen J, Vimpeli SM, Kauko T, Merisaari H, Kallajoki M, Mirtti T, Lamminen T, Saunavaara J, Aronen HJ, Bostrom PJ. Validation of IMPROD biparametric MRI in men with clinically suspected prostate cancer: A prospective multi-institutional trial. PLoS Med. 2019 Jun 3;16(6):e1002813. doi: 10.1371/journal.pmed.1002813. eCollection 2019 Jun. — View Citation

Koh DM, Collins DJ. Diffusion-weighted MRI in the body: applications and challenges in oncology. AJR Am J Roentgenol. 2007 Jun;188(6):1622-35. doi: 10.2214/AJR.06.1403. — View Citation

Le Bihan D, Douek P, Argyropoulou M, Turner R, Patronas N, Fulham M. Diffusion and perfusion magnetic resonance imaging in brain tumors. Top Magn Reson Imaging. 1993 Winter;5(1):25-31. — View Citation

Le Bihan D, Turner R, Douek P, Patronas N. Diffusion MR imaging: clinical applications. AJR Am J Roentgenol. 1992 Sep;159(3):591-9. doi: 10.2214/ajr.159.3.1503032. — View Citation

Leach MO, Brindle KM, Evelhoch JL, Griffiths JR, Horsman MR, Jackson A, Jayson GC, Judson IR, Knopp MV, Maxwell RJ, McIntyre D, Padhani AR, Price P, Rathbone R, Rustin GJ, Tofts PS, Tozer GM, Vennart W, Waterton JC, Williams SR, Workman P; Pharmacodynamic/Pharmacokinetic Technologies Advisory Committee, Drug Development Office, Cancer Research UK. The assessment of antiangiogenic and antivascular therapies in early-stage clinical trials using magnetic resonance imaging: issues and recommendations. Br J Cancer. 2005 May 9;92(9):1599-610. doi: 10.1038/sj.bjc.6602550. — View Citation

Madersbacher S, Alcaraz A, Emberton M, Hammerer P, Ponholzer A, Schroder FH, Tubaro A. The influence of family history on prostate cancer risk: implications for clinical management. BJU Int. 2011 Mar;107(5):716-721. doi: 10.1111/j.1464-410X.2010.10024.x. Epub 2010 Dec 16. — View Citation

Mahal BA, Aizer AA, Ziehr DR, Hyatt AS, Sammon JD, Schmid M, Choueiri TK, Hu JC, Sweeney CJ, Beard CJ, D'Amico AV, Martin NE, Kim SP, Trinh QD, Nguyen PL. Trends in disparate treatment of African American men with localized prostate cancer across National Comprehensive Cancer Network risk groups. Urology. 2014 Aug;84(2):386-92. doi: 10.1016/j.urology.2014.05.009. Epub 2014 Jun 26. — View Citation

Martin AJ, Lord SJ, Verry HE, Stockler MR, Emery JD. Risk assessment to guide prostate cancer screening decisions: a cost-effectiveness analysis. Med J Aust. 2013 Jun 3;198(10):546-50. doi: 10.5694/mja12.11597. Erratum In: Med J Aust. 2014 Mar 3;200(4):205. — View Citation

Mohler JL, Antonarakis ES, Armstrong AJ, D'Amico AV, Davis BJ, Dorff T, Eastham JA, Enke CA, Farrington TA, Higano CS, Horwitz EM, Hurwitz M, Ippolito JE, Kane CJ, Kuettel MR, Lang JM, McKenney J, Netto G, Penson DF, Plimack ER, Pow-Sang JM, Pugh TJ, Richey S, Roach M, Rosenfeld S, Schaeffer E, Shabsigh A, Small EJ, Spratt DE, Srinivas S, Tward J, Shead DA, Freedman-Cass DA. Prostate Cancer, Version 2.2019, NCCN Clinical Practice Guidelines in Oncology. J Natl Compr Canc Netw. 2019 May 1;17(5):479-505. doi: 10.6004/jnccn.2019.0023. — View Citation

Nasu K, Kuroki Y, Tsukamoto T, Nakajima H, Mori K, Minami M. Diffusion-weighted imaging of surgically resected hepatocellular carcinoma: imaging characteristics and relationship among signal intensity, apparent diffusion coefficient, and histopathologic grade. AJR Am J Roentgenol. 2009 Aug;193(2):438-44. doi: 10.2214/AJR.08.1424. — View Citation

Odedina FT, Akinremi TO, Chinegwundoh F, Roberts R, Yu D, Reams RR, Freedman ML, Rivers B, Green BL, Kumar N. Prostate cancer disparities in Black men of African descent: a comparative literature review of prostate cancer burden among Black men in the United States, Caribbean, United Kingdom, and West Africa. Infect Agent Cancer. 2009 Feb 10;4 Suppl 1(Suppl 1):S2. doi: 10.1186/1750-9378-4-S1-S2. — View Citation

Padhani AR, Liu G, Koh DM, Chenevert TL, Thoeny HC, Takahara T, Dzik-Jurasz A, Ross BD, Van Cauteren M, Collins D, Hammoud DA, Rustin GJ, Taouli B, Choyke PL. Diffusion-weighted magnetic resonance imaging as a cancer biomarker: consensus and recommendations. Neoplasia. 2009 Feb;11(2):102-25. doi: 10.1593/neo.81328. — View Citation

Parker PM, Rice KR, Sterbis JR, Chen Y, Cullen J, McLeod DG, Brassell SA. Prostate cancer in men less than the age of 50: a comparison of race and outcomes. Urology. 2011 Jul;78(1):110-5. doi: 10.1016/j.urology.2010.12.046. Epub 2011 Mar 12. — View Citation

Platz EA, Rimm EB, Willett WC, Kantoff PW, Giovannucci E. Racial variation in prostate cancer incidence and in hormonal system markers among male health professionals. J Natl Cancer Inst. 2000 Dec 20;92(24):2009-17. doi: 10.1093/jnci/92.24.2009. — View Citation

Qaseem A, Barry MJ, Denberg TD, Owens DK, Shekelle P; Clinical Guidelines Committee of the American College of Physicians. Screening for prostate cancer: a guidance statement from the Clinical Guidelines Committee of the American College of Physicians. Ann Intern Med. 2013 May 21;158(10):761-769. doi: 10.7326/0003-4819-158-10-201305210-00633. — View Citation

Qiao EM, Lynch JA, Lee KM, Kotha NV, Nalawade V, Voora RS, Qian AS, Nelson TJ, Yamoah K, Garraway IP, Stewart TF, Parsons JK, Rose BS. Evaluating Prostate-Specific Antigen Screening for Young African American Men With Cancer. J Natl Cancer Inst. 2022 Apr 11;114(4):592-599. doi: 10.1093/jnci/djab221. — View Citation

Sanda MG, Cadeddu JA, Kirkby E, Chen RC, Crispino T, Fontanarosa J, Freedland SJ, Greene K, Klotz LH, Makarov DV, Nelson JB, Rodrigues G, Sandler HM, Taplin ME, Treadwell JR. Clinically Localized Prostate Cancer: AUA/ASTRO/SUO Guideline. Part I: Risk Stratification, Shared Decision Making, and Care Options. J Urol. 2018 Mar;199(3):683-690. doi: 10.1016/j.juro.2017.11.095. Epub 2017 Dec 15. — View Citation

Siegel R, Naishadham D, Jemal A. Cancer statistics, 2012. CA Cancer J Clin. 2012 Jan-Feb;62(1):10-29. doi: 10.3322/caac.20138. Epub 2012 Jan 4. — View Citation

Vickers AJ, Ulmert D, Sjoberg DD, Bennette CJ, Bjork T, Gerdtsson A, Manjer J, Nilsson PM, Dahlin A, Bjartell A, Scardino PT, Lilja H. Strategy for detection of prostate cancer based on relation between prostate specific antigen at age 40-55 and long term risk of metastasis: case-control study. BMJ. 2013 Apr 15;346:f2023. doi: 10.1136/bmj.f2023. — View Citation

Weinrich SP. Prostate cancer screening in high-risk men: African American Hereditary Prostate Cancer Study Network. Cancer. 2006 Feb 15;106(4):796-803. doi: 10.1002/cncr.21674. — View Citation

Zhen JT, Syed J, Nguyen KA, Leapman MS, Agarwal N, Brierley K, Llor X, Hofstatter E, Shuch B. Genetic testing for hereditary prostate cancer: Current status and limitations. Cancer. 2018 Aug 1;124(15):3105-3117. doi: 10.1002/cncr.31316. Epub 2018 Apr 18. Erratum In: Cancer. 2019 Jul 1;125(13):2325. — View Citation

* Note: There are 38 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of suspicious lesions on MRI in men with PSA less than 2.5 ng/ml	To determine the incidence of positive mpMRI prostate in a high-risk cohort of men as a screening tool for prostate cancer.	3 months
Secondary	Prostate cancer detection rate using 3T bpMRI in patients with high risk and suspicious lesions on bpMRI	Proportion of men with suspicious lesion found to have cancer on biopsy, this is the PPV based on the prevalence of this population.	3 months
Secondary	Association of whether findings on bpMRI and serum PSA (i.e. PSA density) are associated with future diagnosis of prostate cancer.	Proportion diagnosed with prostate cancer over 5 year follow-up among patients who were not diagnosed with prostate cancer based on findings of initial mpMRI (i.e. mend who either did not have any suspicious lesions or had suspicious lesions but were negative for cancer on biopsy)	5 years
Secondary	To correlate bpMRI findings with future changes in PSA	PSA density will be measured every year for five years	5 years

External Links

•   Accessing Data
•   Guidance for Industry and FDA Staff: Criteria for Significant Risk Investigations of Magnetic Resonance Diagnostic Devices
•   How to Market Your Device
•   How to market Your Device (2)
•   Medical Device Regulation and Overview General and Special Controls
•   Post Market Regulation Requirements