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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bi-parametric Screening MRI | Experimental | Bi-parametric MRI to be administered to High Risk males |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bi-parametric MRI | Diagnostic Test | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Association of whether findings on bpMRI and serum PSA (i.e. PSA density) are associated with future diagnosis of prostate cancer. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cynthia Knauer, RN | Contact | 516-734-8500 | urologyresearch@northwell.edu | |
| Monica Johnson | Contact | 516-734-8500 | urologyresearch@northwell.edu |
| Name | Affiliation | Role |
|---|---|---|
| Ardeshir Rastinehad, DO | Northwell Health | Principal Investigator |
| Manish Vira, MD | Northwell Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cynthia Knauer | Recruiting | Lake Success | New York | 11042 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29203269 | Background | 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. | |
| 23567643 |
| Label | URL |
|---|---|
| Guidance for Industry and FDA Staff: Criteria for Significant Risk Investigations of Magnetic Resonance Diagnostic Devices | View source |
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There is no plan to share IPD with other researchers
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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|
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 |
| To correlate bpMRI findings with future changes in PSA | PSA density will be measured every year for five years | 5 years |
| Background |
| 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. |
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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |