Prostate CancerNCT05384535
Utility of Biparametric MRI (Magnetic Resonance Imaging) as a Screening Tool for Prostate Cancer in a High-Risk Cohort
A study testing Bi-parametric MRI in people with Prostate Cancer and Magnetic Resonance Imaging, run by Northwell Health at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 40 to 55 years, men only
- Conditions the study is for
- Prostate Cancer, Magnetic Resonance Imaging, Population at Risk
- What is being tested?
- Bi-parametric MRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2022to 31 Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 55 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Cynthia Knauer
Lake Success, New York, 11042
Cynthia Knauer, 516-734-8500, urologyresearch@northwell.edu
Monica Johnson, 516-734-8500, urologyresesearch@northwell.edu
About this study
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.
Read the 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.
- Being tested
- Bi-parametric MRI
- Keywords
- Prostate Cancer, Screening, Magnetic Resonance Imaging
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bi-parametric MRIDiagnostic 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
| Study group | Role | What they receive |
|---|---|---|
| Bi-parametric Screening MRI | Experimental | Bi-parametric MRI to be administered to High Risk males Receives: Diagnostic Test: Bi-parametric MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (3)
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.
Measured: 3 months
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)
Measured: 5 years
To correlate bpMRI findings with future changes in PSA
PSA density will be measured every year for five years
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2022
- Study start15 Aug 2022
- Primary completion31 Oct 2027 (estimated)
- Study completion31 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (38)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Northwell HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ardeshir Rastinehad, DO, Principal investigator, Northwell HealthManish Vira, MD, Principal investigator, Northwell Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05384535
- Sponsor's protocol ID
- 21-1380
- Status last verified
- Nov 2025
- First submitted
- 17 May 2022
- Last updated
- 24 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: There is no plan to share IPD with other researchers
Publications
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 29203269Qaseem 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 23567643Mohler 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 31085757Catalona 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 1707140Hofbauer 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 29733838Ahmed 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 28110982Siegel 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 22237781Zhen 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 29669169Vickers 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 23596126Hu 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 22394583Fleshner 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 9224334Brown 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 30040065Drost 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 31022301Elwenspoek 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 31390032Weinrich 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 16411222
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utility of Biparametric MRI (Magnetic Resonance Imaging) as a Screening Tool for Prostate Cancer in a High-Risk Cohort
- ClinicalTrials.gov ID
- NCT05384535
- Acronym / sponsor ID
- 21-1380
- Keywords
- Prostate Cancer, Screening, Magnetic Resonance Imaging
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Study start
- 15 Aug 2022 (actual)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 31 Oct 2028 (estimated)
- First posted
- 20 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bi-parametric Screening MRI | Experimental | Diagnostic Test: Bi-parametric MRIBi-parametric MRI to be administered to High Risk males |
Who may qualify
- Ages
- 40 to 55 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bi-parametric MRIWhen 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 | Diagnostic test | Bi-parametric Screening MRI |
Primary outcome
Proportion of suspicious lesions on MRI in men with PSA less than 2.5 ng/ml
Time frame: 3 months
To determine the incidence of positive mpMRI prostate in a high-risk cohort of men as a screening tool for prostate cancer.
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2025.
- Background: PubMed 29203269Sanda 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.
- Background: PubMed 23567643Qaseem 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.
- Background: PubMed 31085757Mohler 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.
- Background: PubMed 1707140Catalona 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.
- Background: PubMed 29733838Hofbauer 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.
- Background: PubMed 28110982Ahmed 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.
- Background: PubMed 22237781Siegel 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.
- Background: PubMed 29669169Zhen 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.
- Background: PubMed 23596126Vickers 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.
- Background: PubMed 22394583Hu 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.
- Background: PubMed 9224334Fleshner 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.
- Background: PubMed 30040065Brown 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.
- Guidance for Industry and FDA Staff: Criteria for Significant Risk Investigations of Magnetic Resonance Diagnostic DevicesLink provided by the sponsor.
- Medical Device Regulation and Overview General and Special ControlsLink provided by the sponsor.
- How to Market Your DeviceLink provided by the sponsor.
- How to market Your Device (2)Link provided by the sponsor.
- Accessing DataLink provided by the sponsor.
- Post Market Regulation RequirementsLink provided by the sponsor.
- Individual participant dataSharing planned: No. There is no plan to share IPD with other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ardeshir Rastinehad, DO principal investigator
Northwell Health
Manish Vira, MD principal investigator
Northwell Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bi-parametric MRI in people with Prostate Cancer and Magnetic Resonance Imaging, run by Northwell Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cynthia Knauer, RN (516-734-8500, urologyresearch@northwell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of suspicious lesions on MRI in men with PSA less than 2.5 ng/ml (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05384535, which also lists 38 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2025.