Abbreviated Biparametric MRI for Prostate Cancer

Overseen By Aradhana Venkatesan

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: M.D. Anderson Cancer Center

Must not be taking: Androgen deprivation therapy

Disqualifiers: Prior surgery, Radiotherapy, Pacemakers, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new MRI method for detecting prostate cancer. The goal is to determine if a simpler and cheaper MRI, called Abbreviated Biparametric MRI (RSI + T2WI), can accurately detect prostate cancer before treatment while skipping some steps. The study seeks men diagnosed with significant prostate cancer who plan to undergo surgery or a biopsy at MD Anderson. Participants should not have received any previous treatments, such as surgery or radiation, for their prostate cancer. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants the chance to contribute to advancements in prostate cancer detection.

Do I need to stop my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What prior data suggests that this MRI technique is safe for prostate cancer management?

Research has shown that the shorter biparametric MRI for detecting prostate cancer is generally safe and well-tolerated. Studies have found that this MRI method, which uses two types of imaging, provides results similar to the more detailed multiparametric MRI. The main difference is that it doesn't use gadolinium, a contrast dye used in some MRIs.

By not using gadolinium, the scan avoids potential side effects from this dye, enhancing safety. Additionally, this shorter method reduces the time and cost of the procedure, making it more convenient for patients. Overall, evidence suggests that this shorter MRI is a safe option for checking prostate cancer. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Abbreviated Biparametric MRI for prostate cancer because it offers a potentially more effective and efficient way to detect this condition compared to the standard MRI methods. Unlike traditional MRI techniques, this method uses restriction spectrum imaging (RSI) combined with T2-weighted imaging (T2WI), which might improve the accuracy of detecting prostate cancer. This approach could lead to earlier and more precise diagnoses, helping to tailor treatment plans more effectively for patients.

What evidence suggests that this MRI technique is effective for prostate cancer?

Research has shown that a simpler type of MRI, called abbreviated biparametric MRI (bpMRI), matches the effectiveness of the standard multiparametric MRI (mpMRI) in detecting prostate cancer. This trial will assess bpMRI's effectiveness, which uses two imaging techniques without requiring a contrast dye, simplifying the process. Studies confirm that bpMRI detects cancer as effectively as the more complex mpMRI. Additionally, bpMRI can lower scan costs by 30% and reduce scan time by 40%. These findings suggest that bpMRI provides a reliable and efficient method for detecting prostate cancer. ^{1 3 5 6 7}

Who Is on the Research Team?

Aradhana Venkatesan

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for treatment-naive patients with clinically significant prostate cancer (Gleason score > 3+4, cancer core length > 4mm) needing an MRI before treatment or biopsy. Excluded are those with pacemakers, conditions preventing MR imaging at 3T, under age 18, unable to use an endorectal coil, prior androgen therapy or prostate treatments, over 400 pounds weight, unable to consent or recent biopsy.

Inclusion Criteria

I am expected to have a biopsy guided by fusion imaging at MD Anderson.

I have intermediate risk prostate cancer and have not received any treatment yet.

I am expected to have surgery at MD Anderson and will be followed up clinically.

Exclusion Criteria

Patients allergic to gadolinium

Patients unable to tolerate an endorectal coil

Patients whose weight exceeds 400 pounds

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging and Biopsy

Participants undergo T2 weighted imaging (T2WI) and restriction spectrum imaging (RSI) for prostate cancer detection, followed by MRI/US fusion guided biopsy

1-2 weeks

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after imaging and biopsy procedures

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Abbreviated Biparametric MRI (RSI + T2WI)

Trial Overview The study tests a simplified MRI method called biparametric MRI (RSI + T2WI), which could be faster and cheaper than the standard multiparametric MRI by omitting certain sequences like DCE imaging. It aims to see if this simpler method can still effectively detect and stage prostate cancer.

How Is the Trial Designed?

Group I: MRI technique Experimental Treatment 1 Intervention

restriction spectrum imaging (RSI) can detect prostate cancer better than a standard-of-care MRI.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Published Research Related to This Trial

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]

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]

Multiparametric MRI (mp-MRI) can effectively exclude prostate cancer progression in patients on active surveillance, with a negative predictive value (NPV) of 100%, suggesting that stable mp-MRI results may allow for the avoidance of standard serial biopsies.

In cases where mp-MRI indicates signs of tumor progression, over 60% of patients experienced a Gleason score upgrade upon re-biopsy, highlighting the importance of targeted re-biopsies when higher-grade cancer is suspected.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multiparametric magnetic resonance imaging can exclude prostate cancer progression in patients on active surveillance: a retrospective cohort study. Ullrich, T., Arsov, C., Quentin, M., et al.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05046782

Abbreviated Biparametric MRI (RSI + T2WI) for Prostate ... The primary objective of this study is to compare the diagnostic accuracy of T2 weighted imaging (T2WI) and restriction spectrum imaging (RSI) (T2WI + RSI) to ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36651358/

Comparison of a Deep Learning-Accelerated vs. Conventional ... To compare conventional bpMRIs (CL-bpMRI) with bpMRIs including a deep learning-accelerated T2WI (DL-bpMRI) in diagnosing prostate cancer.

3. sciencedirect.com sciencedirect.com/science/article/pii/S107663322500618X

Enhanced Detection of Prostate Cancer Lesions on ... Biparametric MRI cases comprising T2WI, diffusion-weighted images, and apparent diffusion coefficient were retrospectively collected. Three ...

4. link.springer.com link.springer.com/article/10.1007/s00330-025-11837-1

Diagnostic accuracy of abbreviated biparametric MRI for ... Of 31 men with clinically significant PCa, 87% (27/31) had a positive screening MRI and 42% (13/31) had raised PSAd. The PPV of the screening ...

5. ajronline.org ajronline.org/doi/10.2214/AJR.18.20103

Abbreviated Biparametric Versus Standard Multiparametric ... Meta-analysis showed no statistically significant difference between bpMRI and mpMRI for the diagnosis of PCa, and the areas under the summary ROC (SROC) curves ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8871361/

Diagnostic Accuracy of Abbreviated Bi-Parametric MRI (a- ... Out of 406 men, 43 had a positive MRI using a cut-off of PI-RADS score 4–5 (scan positive rate: 10.6%); among these, csPCa was found in 11/43 ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11399179/

Biparametric MRI in prostate cancer during active ... Active surveillance is the preferred plan for patients with lower-risk prostate cancer, and MRI plays a crucial role in patient selection and monitoring.