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

Trial Summary

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 data supports the effectiveness of the treatment Bi-parametric MRI for prostate cancer?

Research shows that biparametric MRI (bpMRI) is effective in detecting prostate cancer, especially in patients with elevated PSA levels. It has been found to be a reliable method for identifying significant prostate cancer, comparable to the more complex multiparametric MRI (mpMRI), but with fewer drawbacks. ^{1 2 3 4 5}

Is biparametric MRI safe for humans?

The research does not provide specific safety data for biparametric MRI, but MRI procedures are generally considered safe for humans as they do not use ionizing radiation. ^{1 6 7 8 9}

How is biparametric MRI different from other treatments for prostate cancer?

Biparametric MRI (bpMRI) is a faster, simpler, and less expensive imaging method for detecting prostate cancer compared to the traditional multiparametric MRI (mpMRI). It does not require the use of contrast agents, making it a more accessible option for screening and potentially reducing the need for unnecessary biopsies. ^{1 2 4 9 10}

What is the purpose of this trial?

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.

Research Team

Ardeshir Rastinehad, DO

Principal Investigator

Northwell Health

Manish Vira, MD

Principal Investigator

Northwell Health

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

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]

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]

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]

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]

References

1. Greece pubmed.ncbi.nlm.nih.gov

Biparametric versus Multiparametric MRI with Non-endorectal Coil at 3T in the Detection and Localization of Prostate Cancer. [2017]

2. Germany pubmed.ncbi.nlm.nih.gov

Can the combination of biparametric magnetic resonance imaging and PSA-related indicators predict the prostate biopsy outcome? [2021]

3. United States 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). [2020]

4. Austria pubmed.ncbi.nlm.nih.gov

Short review of biparametric prostate MRI. [2020]

5. Ireland 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? [2018]

6. Germany pubmed.ncbi.nlm.nih.gov

Relationship between non-suspicious MRI and insignificant prostate cancer: results from a monocentric study. [2018]

7. New Zealand 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? [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Temporary Health Impact of Prostate MRI and Transrectal Prostate Biopsy in Active Surveillance Prostate Cancer Patients. [2020]

9. United States 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. [2022]

10. England 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. [2023]