RecruitingInterventional

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

NCT ID: NCT05384535Sponsor: Northwell HealthLast updated: 2025-11-24

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.

Detailed 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.

Arms & interventions

Diagnostic TestBi-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

Outcome measures

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.
Time frame: 3 months

Secondary

Prostate cancer detection rate using 3T bpMRI in patients with high risk and suspicious lesions on bpMRI
Time frame: 3 months
Association of whether findings on bpMRI and serum PSA (i.e. PSA density) are associated with future diagnosis of prostate cancer.
Time frame: 5 years
To correlate bpMRI findings with future changes in PSA
Time frame: 5 years

Eligibility criteria

Sex: MaleAge: 40 Years to 55 YearsHealthy volunteers: No

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

Study locations (1)

Cynthia Knauer

Lake Success, New York, 11042

Recruiting

Cynthia Knauer · Contact

516-734-8500 urologyresearch@northwell.edu

Monica Johnson · Contact

516-734-8500 urologyresesearch@northwell.edu

Ardeshir Rastinehad, DO · Principal Investigator

Manish Vira, MD · Principal Investigator

References

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.(PubMed)
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.(PubMed)
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.(PubMed)
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.(PubMed)
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.(PubMed)
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.(PubMed)
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.(PubMed)
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.(PubMed)
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.(PubMed)
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.(PubMed)
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.(PubMed)
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.(PubMed)
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.(PubMed)
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.(PubMed)
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.(PubMed)