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

Primary Purpose

Prostate Cancer, Magnetic Resonance Imaging, Population at Risk

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Bi-parametric MRI

About this trial

This is an interventional screening trial for Prostate Cancer focused on measuring Prostate Cancer, Screening, Magnetic Resonance Imaging

Eligibility Criteria

40 Years - 55 Years (Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

PSA between 1.0 and 2.5 ng/dL
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
Patient is willing to participated in prostate cancer screening
Patient is capable of giving informed consent

Exclusion Criteria:

Nodularity or firmness of prostate on exam
Patient has undergone a prior biopsy or prostate surgery
Patient is taking 5-alpha reductase inhibitors to manage benign prostatic hyperplasia, as this can significantly alter PSA levels.
Patient has a history of UTI or prostatitis in the preceding 6 months, as this can significantly alter PSA levels.
Patient has a contraindication to MRI, these include but are not limited to pacemakers, neurostimulator devices, metal cardiac valves, certain tattoos, or foreign bodies
Participants that experience claustrophobia, anxiety and/or vertigo when moved inside the scanner
The participant cannot tolerate lying flat for the study duration

Sites / Locations

Cynthia KnauerRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Bi-parametric Screening MRI

Arm Description

Bi-parametric MRI to be administered to High Risk males

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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)

To correlate bpMRI findings with future changes in PSA

PSA density will be measured every year for five years

Full Information

NCT ID

NCT05384535

First Posted

May 17, 2022

Last Updated

August 28, 2023

Sponsor

Northwell Health

1. Study Identification

Unique Protocol Identification Number

NCT05384535

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Recruiting

Study Start Date

August 15, 2022 (Actual)

Primary Completion Date

October 31, 2023 (Anticipated)

Study Completion Date

October 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Northwell Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Cancer, Magnetic Resonance Imaging, Population at Risk

Keywords

Prostate Cancer, Screening, Magnetic Resonance Imaging

7. Study Design

Primary Purpose

Screening

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Bi-parametric Screening MRI

Arm Type

Experimental

Arm Description

Bi-parametric MRI to be administered to High Risk males

Intervention Type

Diagnostic Test

Intervention Name(s)

Bi-parametric MRI

Intervention Description

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

Primary Outcome Measure Information:

Title

Proportion of suspicious lesions on MRI in men with PSA less than 2.5 ng/ml

Description

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 Outcome Measure Information:

Title

Prostate cancer detection rate using 3T bpMRI in patients with high risk and suspicious lesions on bpMRI

Description

Proportion of men with suspicious lesion found to have cancer on biopsy, this is the PPV based on the prevalence of this population.

Time Frame

3 months

Title

Association of whether findings on bpMRI and serum PSA (i.e. PSA density) are associated with future diagnosis of prostate cancer.

Description

Time Frame

5 years

Title

To correlate bpMRI findings with future changes in PSA

Description

PSA density will be measured every year for five years

Time Frame

5 years

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: PSA between 1.0 and 2.5 ng/dL 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 Patient is willing to participated in prostate cancer screening Patient is capable of giving informed consent Exclusion Criteria: Nodularity or firmness of prostate on exam Patient has undergone a prior biopsy or prostate surgery Patient is taking 5-alpha reductase inhibitors to manage benign prostatic hyperplasia, as this can significantly alter PSA levels. Patient has a history of UTI or prostatitis in the preceding 6 months, as this can significantly alter PSA levels. Patient has a contraindication to MRI, these include but are not limited to pacemakers, neurostimulator devices, metal cardiac valves, certain tattoos, or foreign bodies Participants that experience claustrophobia, anxiety and/or vertigo when moved inside the scanner The participant cannot tolerate lying flat for the study duration

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Cynthia Knauer, RN

Phone

516-734-8500

urologyresearch@northwell.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Monica Johnson

Phone

516-734-8500

urologyresearch@northwell.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ardeshir Rastinehad, DO

Organizational Affiliation

Northwell Health

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Manish Vira, MD

Organizational Affiliation

Northwell Health

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cynthia Knauer

City

Lake Success

State/Province

New York

ZIP/Postal Code

11042

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Cynthia Knauer

Phone

516-734-8500

urologyresearch@northwell.edu

First Name & Middle Initial & Last Name & Degree

Monica Johnson

Phone

516-734-8500

urologyresesearch@northwell.edu

First Name & Middle Initial & Last Name & Degree

Ardeshir Rastinehad, DO

First Name & Middle Initial & Last Name & Degree

Manish Vira, MD

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

There is no plan to share IPD with other researchers

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Links:

URL

https://www.fda.gov/media/71385/download

Description

Guidance for Industry and FDA Staff: Criteria for Significant Risk Investigations of Magnetic Resonance Diagnostic Devices

URL

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/GeneralandSpecialControls/ucm055910.htm

Description

Medical Device Regulation and Overview General and Special Controls

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http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/RegistrationandListing/ucm053165.htm

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How to Market Your Device

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http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/RegistrationandListing/ucm053156.htm

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How to market Your Device (2)

URL

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm

Description

Accessing Data

URL

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/QualitySystemsRegulations/default.htm

Description

Post Market Regulation Requirements

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

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