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

302 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new MRI scan method for men with newly diagnosed prostate cancer. The scan combines detailed imaging and water movement analysis to detect cancer. The goal is to see if this method is as effective as the standard MRI but simpler and cheaper.

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 data supports the effectiveness of the treatment Abbreviated Biparametric MRI (RSI + T2WI) for prostate cancer?

Research shows that multiparametric MRI, which includes T2-weighted imaging, is effective in diagnosing and managing prostate cancer. A study comparing biparametric MRI (which includes T2-weighted imaging) to multiparametric MRI found it useful for diagnosing prostate cancer, suggesting that the abbreviated version may still be effective. ^{1 2 3 4 5}

Is Abbreviated Biparametric MRI safe for humans?

The research articles do not provide specific safety data for Abbreviated Biparametric MRI, but they do discuss its use in prostate cancer patients, suggesting it is generally considered safe for this purpose. ^{6 7 8 9 10}

How is the Abbreviated Biparametric MRI treatment different from other prostate cancer treatments?

The Abbreviated Biparametric MRI (RSI + T2WI) is a quicker and simpler imaging method compared to the traditional multiparametric MRI, taking about 15 minutes instead of 40. It uses fewer scan sequences, making it a more efficient option for detecting and managing prostate cancer, especially in men who have not yet had a biopsy. ^{1 11 12 13 14}

Research Team

Aradhana Venkatesan

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

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

Magnetic resonance imaging of prostate cancer. [2018]

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

Multiparametric magnetic resonance imaging can exclude prostate cancer progression in patients on active surveillance: a retrospective cohort study. [2021]

3. China pubmed.ncbi.nlm.nih.gov

Current role of multiparametric magnetic resonance imaging for prostate cancer. [2022]

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

Arguments against using an abbreviated or biparametric prostate MRI protocol. [2021]

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

Head-to-Head Comparison Between Biparametric and Multiparametric MRI for the Diagnosis of Prostate Cancer: A Systematic Review and Meta-Analysis. [2019]

6. England pubmed.ncbi.nlm.nih.gov

The effect of capped biparametric magnetic resonance imaging slots on weekly prostate cancer imaging workload. [2022]

7. Ireland pubmed.ncbi.nlm.nih.gov

Analysis of PI-RADS 4 cases: Management recommendations for negatively biopsied patients. [2019]

8. England pubmed.ncbi.nlm.nih.gov

Effect of preoperative PI-RADS assessment on pathological outcomes in patients who underwent radical prostatectomy. [2023]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Role of Multi-Parametric Magnetic Resonance Image and PIRADS Score in Patients with Prostate Cancer Eligible for Active Surveillance According PRIAS Criteria. [2022]

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

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

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

Simplified PI-RADS-based biparametric MRI: A rationale for detecting and managing prostate cancer. [2021]

12. Australia pubmed.ncbi.nlm.nih.gov

Multiparametric magnetic resonance imaging: Current role in prostate cancer management. [2022]

13. 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]

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

Interpretation and reporting multiparametric prostate MRI: a primer for residents and novices. [2014]