Biparametric MRI Screening for Prostate Cancer

Overseen By Cynthia Knauer, RN

Age: 18 - 65

Sex: Male

Trial Phase: Academic

Sponsor: Northwell Health

Must not be taking: 5-alpha reductase inhibitors

Disqualifiers: Prostate nodularity, Prior biopsy, UTI, MRI contraindications, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a special type of MRI scan, called bi-parametric MRI, can improve prostate cancer screening for individuals at high risk. The aim is to determine if this scan, combined with a PSA blood test, enhances the effectiveness of prostate cancer detection. Suitable candidates for this trial include men with a PSA level between 1.0 and 2.5, those of Black descent, individuals with a close male relative who has prostate cancer, or those carrying certain genetic markers (such as BRCA 1/2). Participants must be willing to undergo prostate cancer screening and able to provide consent. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance early detection methods for prostate cancer.

Will I have to stop taking my current medications?

If you are taking 5-alpha reductase inhibitors for benign prostatic hyperplasia, you will need to stop, as they can affect PSA levels. The trial does not specify about other medications.

What prior data suggests that this bi-parametric MRI is safe for prostate cancer screening?

Research has shown that biparametric MRI (bpMRI) is safe for people. Studies have found that bpMRI works as well as multiparametric MRI in detecting prostate cancer. Importantly, no major safety issues have been reported with bpMRI, indicating that patients tolerate it well. Unlike some tests, bpMRI does not require invasive procedures or use radiation, reducing the risk of side effects. In summary, current evidence supports the safety of bpMRI for prostate cancer screening in individuals at high risk. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about bi-parametric MRI for prostate cancer screening because it offers a radiation-free alternative to traditional methods like PSA tests and multiparametric MRI. Unlike standard MRI techniques that require contrast agents, bi-parametric MRI uses fewer scans, focusing on just two key imaging sequences. This approach not only reduces the procedure time and cost but also minimizes patient discomfort and risk, potentially making prostate cancer detection quicker and more accessible.

What evidence suggests that bi-parametric MRI is effective for prostate cancer screening?

Research has shown that bi-parametric MRI (bpMRI), which participants in this trial will receive, effectively detects prostate cancer. Studies have demonstrated that bpMRI matches multiparametric MRI (mpMRI) in identifying significant prostate cancer cases. In one study, bpMRI detected 83 cases, while mpMRI found 84. Another study confirmed that bpMRI is as effective as mpMRI for diagnosing important prostate cancer. This suggests that bpMRI can reliably screen for prostate cancer, especially in high-risk individuals. ^{1 2 3 6 7}

Who Is on the Research Team?

Ardeshir Rastinehad, DO

Principal Investigator

Northwell Health

Manish Vira, MD

Principal Investigator

Northwell Health

Are You a Good Fit for This Trial?

This trial is for men at high risk of prostate cancer, which includes Black men or those with a family history (father, brother) or specific genetic mutations (BRCA 1/2, HOX B13). Participants should have PSA levels between 1.0 and 2.5 ng/dL and be able to consent. Men who've had recent UTIs, prostatitis, prostate surgery/biopsy, take certain medications for enlarged prostate, or can't undergo MRI are excluded.

Inclusion Criteria

I am able to understand and agree to the study's procedures and risks.

PSA between 1.0 and 2.5 ng/dL

Patient is willing to participate in prostate cancer screening

Exclusion Criteria

I feel claustrophobic, anxious, or dizzy in tight spaces like a scanner.

I cannot lie flat for long periods.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Bi-parametric MRI Screening

Bi-parametric MRI is administered to high-risk males to detect suspicious lesions

3 months

Follow-up

Participants are monitored annually with serum PSA for 5 years

5 years

What Are the Treatments Tested in This Trial?

Interventions

• Bi-parametric MRI

Trial Overview

The study tests if biparametric MRI as a screening tool alongside PSA testing improves detection of prostate cancer in high-risk individuals. It aims to see whether this method can better identify patients who may need further investigation compared to current screening protocols.

How Is the Trial Designed?

Group I: Bi-parametric Screening MRI Experimental Treatment 1 Intervention

Bi-parametric MRI to be administered to High Risk males

Bi-parametric MRI is already approved in European Union, United States, United Kingdom for the following indications:

Approved in European Union as Biparametric MRI for:

• Prostate cancer screening

Approved in United States as Biparametric MRI for:

• Prostate cancer screening

Approved in United Kingdom as Biparametric MRI for:

• Prostate cancer screening

Who Is Running the Clinical Trial?

Northwell Health

Lead Sponsor

Trials

481

Recruited

470,000+

Published Research Related to This Trial

In a study of 78 men with non-suspicious multiparametric MRI results, 92.3% had no cancer detected in subsequent biopsies, indicating a high negative predictive value for mpMRI in ruling out significant prostate cancer.

Among the few cases where prostate cancer was found (7.7%), the majority were classified as indolent, suggesting that non-suspicious mpMRI can effectively identify patients at low risk for aggressive disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Relationship between non-suspicious MRI and insignificant prostate cancer: results from a monocentric study. Renard-Penna, R., Roupret, M., Compérat, E., et al.[2018]

Biparametric MRI (bpMRI) is effective in detecting and localizing prostate cancer lesions, showing a sensitivity of 100% for index lesions in the peripheral zone and comparable sensitivity to multiparametric MRI (mpMRI).

In a study of 41 patients who underwent radical prostatectomy, bpMRI detected more lesions (181) than were confirmed histologically (131), resulting in a false-positive rate of 27.6% and a low false-negative rate of 3.3%, indicating its potential utility despite some inaccuracies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biparametric versus Multiparametric MRI with Non-endorectal Coil at 3T in the Detection and Localization of Prostate Cancer. Scialpi, M., Prosperi, E., D'Andrea, A., et al.[2017]

In a study of 122 men with Gleason 6 prostate cancer, transrectal prostate biopsy was found to have a significantly greater temporary negative impact on quality of life compared to prostate multiparametric MRI (mpMRI), with quality of life scores of 0.82 versus 0.95, respectively.

The most notable difference in health impact was related to intraprocedural pain, where biopsy patients reported much higher pain levels than those undergoing mpMRI, indicating that mpMRI may be a safer and less painful option for monitoring prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Temporary Health Impact of Prostate MRI and Transrectal Prostate Biopsy in Active Surveillance Prostate Cancer Patients. Shankar, PR., Maturen, KE., George, AK., et al.[2020]

A biparametric MRI (BP-MRI) protocol for detecting prostate cancer demonstrated comparable diagnostic accuracy to the standard multiparametric MRI (MP-MRI) protocol, with area under the curve values of 0.91 and 0.93, respectively, based on a study of 82 biopsy-naïve patients.

BP-MRI offers a more efficient alternative to MP-MRI, requiring less time for acquisition and interpretation, and does not require the use of gadolinium-based contrast agents, making it a safer option for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biparametric 3T Magnetic Resonance Imaging for prostatic cancer detection in a biopsy-naïve patient population: a further improvement of PI-RADS v2? Stanzione, A., Imbriaco, M., Cocozza, S., et al.[2018]

In a study of 161 patients with negative pre-biopsy mpMRI results, the negative predictive value (NPV) for detecting clinically significant prostate cancer (csPCa) was high, but not definitive, indicating that negative mpMRI findings do not guarantee the absence of csPCa.

The detection rates of csPCa were low (5.5% in prior negative biopsy patients and 14.3% in confirmatory biopsy patients), suggesting that even with negative mpMRI results and low prostate-specific antigen density (PSAD), repeat biopsies may still be necessary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can Prostate-Specific Antigen Density Be an Index to Distinguish Patients Who Can Omit Repeat Prostate Biopsy in Patients with Negative Magnetic Resonance Imaging? Yu, J., Boo, Y., Kang, M., et al.[2022]

Biparametric MRI (bpMRI) can effectively detect clinically significant prostate cancer, especially for expert readers, showing similar performance to multiparametric MRI (mpMRI) without the need for contrast media.

Less experienced readers struggled with bpMRI, highlighting the importance of experience; they performed significantly better with mpMRI, suggesting that at least 700-800 cases are needed for reliable interpretation of bpMRI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prostate cancer detection with biparametric magnetic resonance imaging (bpMRI) by readers with different experience: performance and comparison with multiparametric (mpMRI). Gatti, M., Faletti, R., Calleris, G., et al.[2020]

Multiparametric MRI (mpMRI) is currently the gold standard for visualizing prostate cancer, but it has several drawbacks that can affect its effectiveness.

Biparametric MRI (bpMRI) has been proposed as a potentially simpler and more efficient alternative to mpMRI, and recent studies are exploring its advantages in prostate cancer detection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Short review of biparametric prostate MRI. Steinkohl, F., Pichler, R., Junker, D.[2020]

Biparametric MRI (bpMRI) using the PI-RADS score is effective in detecting prostate cancer (PCa) and can help rule it out in patients with elevated prostate-specific antigen (PSA) levels, potentially reducing unnecessary biopsies.

A PI-RADS score of 3 is optimal for predicting any prostate cancer, while a score of 4 is best for identifying clinically significant prostate cancer (csPCa), highlighting the importance of using bpMRI alongside PSA-related indicators.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can the combination of biparametric magnetic resonance imaging and PSA-related indicators predict the prostate biopsy outcome? Zhu, J., Liang, Z., Song, Y., et al.[2021]

A biparametric MRI (bpMRI) score-based model significantly improves the detection of clinically significant prostate cancer (csPCa), reducing unnecessary biopsies by allowing urologists to avoid 10 bpMRIs for every one biopsy avoided, based on a study of 275 patients and validation in two additional cohorts.

The bpMRI score shows a strong correlation with the aggressiveness of prostate cancer, as indicated by the International Society of Urological Pathology (ISUP) grade, suggesting it can effectively guide treatment decisions before biopsy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and validation of a nomogram based on biparametric MRI PI-RADS v2.1 and clinical parameters to avoid unnecessary prostate biopsies. Wang, Y., Wang, L., Tang, X., et al.[2023]

Biparametric MRI (bpMRI) is a rapid and effective method for detecting significant prostate cancer, showing a 97% negative predictive value (NPV) in ruling out aggressive disease in biopsy-naive men, which could help avoid unnecessary biopsies.

In a study of 1020 men, bpMRI allowed 30% of those with low-suspicion results to avoid biopsies, while improving the detection of significant prostate cancer by 11% compared to standard biopsy methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of the Diagnostic Accuracy of Biparametric Magnetic Resonance Imaging for Prostate Cancer in Biopsy-Naive Men: The Biparametric MRI for Detection of Prostate Cancer (BIDOC) Study. Boesen, L., Nørgaard, N., Løgager, V., et al.[2022]

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