DBSI-MRI for Prostate Cancer

Overseen By Joseph Ippolito, M.D.

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Washington University School of Medicine

Disqualifiers: Metallic implants, Cochlear implants, Claustrophobia, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

500 Participants Needed

Trial Summary

What is the purpose of this trial?

Diffusion Basis Spectrum Imaging (DBSI) represents a potential leap forward in improving prostate cancer early detection: a non-invasive and accurate imaging test for clinically significant prostate cancer.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems that medications for claustrophobia are allowed if needed for the MRI scan.

What data supports the effectiveness of the DBSI-MRI treatment for prostate cancer?

Research shows that diffusion-weighted imaging (DWI), a component of DBSI-MRI, is useful in detecting and localizing prostate cancer, especially in patients with high risk or previous negative biopsies. This suggests that DBSI-MRI could be effective in identifying prostate cancer by enhancing the imaging quality and accuracy. ^{1 2 3 4 5}

How is DBSI-MRI treatment for prostate cancer different from other treatments?

DBSI-MRI is unique because it uses a specialized MRI technique called Diffusion Basis Spectrum Imaging to better detect and characterize prostate cancer by analyzing how water molecules move in tissues, which can help distinguish between cancerous and healthy tissue more accurately than standard MRI. ^{3 6 7 8 9}

Research Team

Joseph Ippolito, M.D., Ph.D.

Principal Investigator

Washington University School of Medicine

Eligibility Criteria

This trial is for men over 18 who are being checked for prostate cancer either because they have a high PSA level with no previous biopsy, or a high PSA with one negative biopsy. It's also for those already diagnosed and on active surveillance. Men can't join if they have metal implants like pacemakers, cochlear implants, suffer from claustrophobia, can't lie flat for an hour, or had prior prostate surgery.

Inclusion Criteria

I am a man with a high PSA level, may or may not have had a biopsy, or I am on active surveillance for prostate cancer.

I am over 18 and can give my consent.

I am planning to have a prostate biopsy and have never been diagnosed with prostate cancer.

Exclusion Criteria

I do not have metallic implants, cochlear implants, severe claustrophobia, cannot lie flat for over an hour, or had prior prostate surgery.

You have a medical condition that prevents you from having an MRI.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging and Biopsy

Participants undergo MRI with DBSI analysis prior to prostate biopsy

Up to 12 weeks

1 visit (in-person) for MRI and biopsy

Follow-up

Participants are monitored for safety and effectiveness after imaging and biopsy

4 weeks

Treatment Details

Interventions

• MRI with DBSI analysis

Trial Overview The trial is testing Diffusion Basis Spectrum Imaging (DBSI), which is a non-invasive MRI technique that could improve early detection of clinically significant prostate cancer without the need to take tissue samples.

Participant Groups

Group I: Early Detection Cohort (MRI with DBSI) Experimental Treatment 1 Intervention

* Magnetic resonance imaging (MRI) with DBSI analysis prior to prostate biopsy * Standard of care prostate biopsy will be performed within 12 weeks of MRI * Some participants may go on to receive standard of care radical prostatectomy and those participants may have their prostatectomy specimens scanned via MRI with DBSI imaging

Group II: Active Surveillance Cohort (MRI with DBSI) Experimental Treatment 1 Intervention

* Magnetic resonance imaging (MRI) with DBSI analysis prior to prostate biopsy * Standard of care prostate biopsy will be performed within 12 weeks of MRI * Some participants may go on to receive standard of care radical prostatectomy and those participants may have their prostatectomy specimens scanned via MRI with DBSI imaging

MRI with DBSI analysis is already approved in United States, European Union for the following indications:

Approved in United States as MRI with DBSI analysis for:

• Prostate cancer detection and staging

Approved in European Union as MRI with DBSI analysis for:

• Prostate cancer detection and staging

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+

American Cancer Society, Inc.

Collaborator

Trials

237

Recruited

110,000+

Midwest Stone Institute.

Collaborator

Trials

4

Recruited

720+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

The Foundation for Barnes-Jewish Hospital

Collaborator

Trials

43

Recruited

6,600+

Findings from Research

In a study of 51 patients, computed diffusion-weighted imaging (cDWI) in whole-body MRI (bpWB-MRI) showed diagnostic performance for detecting clinically significant prostate cancer (PCa) that is comparable to traditional pelvic MRI, with areas under the curve (AUCs) of 0.86 and 0.89 respectively.

The results suggest that cDWI can be effectively integrated into standard whole-body MRI protocols, allowing for simultaneous detection of both primary and metastatic prostate cancer, enhancing the efficiency of cancer evaluation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diagnostic value of computed high b-value whole-body diffusion-weighted imaging for primary prostate cancer. Arita, Y., Yoshida, S., Waseda, Y., et al.[2021]

In a study of 41 patients with prostate cancer, diffusion-weighted MRI at a b value of 1,500 s/mm² provided the best visibility of cancer lesions, significantly improving the contrast-to-noise ratio compared to other b values.

The research demonstrated that high-resolution diffusion images at 1,500 s/mm² not only enhanced image quality but also allowed for effective prostate cancer depiction without the need for an endorectal coil.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What is the optimal b value in diffusion-weighted MR imaging to depict prostate cancer at 3T? Metens, T., Miranda, D., Absil, J., et al.[2022]

Multiparametric magnetic resonance imaging (mpMRI) using apparent diffusion coefficient (ADC) values has shown a diagnostic accuracy of 84% for identifying clinically significant prostate cancer (Gleason score ≥7), outperforming the traditional PI-RADS score which had an accuracy of 63.6%.

The study established an ADC threshold of 0.747×10-3 mm²/s as effective in distinguishing between lower and higher Gleason scores, suggesting that ADC evaluation can be particularly useful for patients with lower PI-RADS scores who are at risk for prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multiparametric MRI Apparent Diffusion Coefficient (ADC) Accuracy in Diagnosing Clinically Significant Prostate Cancer. Pepe, P., D'Urso, D., Garufi, A., et al.[2018]

In a study of 88 prostate cancer patients, both acquired diffusion-weighted imaging (aDWI) and computed diffusion-weighted imaging (cDWI) showed similar sensitivity for tumor detection, with sensitivities of 94% and 90% respectively, indicating that both imaging techniques are effective for diagnosing prostate cancer.

The inter-observer agreement for tumor detection was moderate for both imaging methods, with kappa values of 0.495 for aDWI and 0.422 for cDWI, suggesting that both techniques provide reliable results that can be consistently interpreted by different reviewers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of Computed Diffusion-Weighted Imaging b2000 and Acquired Diffusion-Weighted Imaging b2000 for Detection of Prostate Cancer. Kim, YJ., Kim, SH., Baek, TW., et al.[2023]

In a study of 43 patients at high risk for prostate cancer, diffusion-weighted imaging (DWI) at 3 Tesla successfully detected prostate cancer in 39.5% of cases, highlighting its efficacy in identifying lesions that were missed in previous biopsies.

DWI was particularly effective in locating tumors in the transitional zone of the prostate, with 76.4% of detected cancers found there, and it provided valuable information that was not always visible on traditional T2-weighted imaging.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lesion localization in patients with a previous negative transrectal ultrasound biopsy and persistently elevated prostate specific antigen level using diffusion-weighted imaging at three Tesla before rebiopsy. Park, BK., Lee, HM., Kim, CK., et al.[2009]

The novel restriction spectrum imaging (RSI-MRI) technique significantly outperformed standard MRI in detecting extraprostatic extension (EPE) in prostate cancer patients, identifying EPE in 89% of cases compared to only 22% with standard MRI.

This study involved 28 prostate cancer patients, and the results suggest that RSI-MRI could greatly enhance the accuracy of prostate cancer imaging, warranting further research for its clinical application.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Novel technique for characterizing prostate cancer utilizing MRI restriction spectrum imaging: proof of principle and initial clinical experience with extraprostatic extension. Rakow-Penner, RA., White, NS., Parsons, JK., et al.[2018]

Biparametric MRI (B-MRI) is effective for detecting prostate cancer, achieving an area under the curve (AUC) of 0.80, which is superior to standard PSA and PSA density tests (AUCs of 0.66 and 0.74, respectively).

Combining B-MRI findings with PSA levels and PSA density significantly enhances the accuracy of prostate cancer detection, with optimized formulas yielding AUCs of 0.83 and 0.87, and an overall detection accuracy of 79%.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diagnostic value of biparametric magnetic resonance imaging (MRI) as an adjunct to prostate-specific antigen (PSA)-based detection of prostate cancer in men without prior biopsies. Rais-Bahrami, S., Siddiqui, MM., Vourganti, S., et al.[2022]

Enhanced correlated diffusion imaging (eD-CDI) significantly improves the detection of prostate cancer compared to traditional imaging methods, as shown in a study involving 17 patients with confirmed prostate cancer.

The optimization of the signal mixing algorithm in eD-CDI allows for better differentiation between cancerous and healthy tissues, enhancing diagnostic accuracy in prostate cancer detection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhanced dual-stage correlated diffusion imaging. Khalvati, F., Junjie Zhang, ., Haider, MA., et al.[2020]

Multiparametric MRI techniques, including 1H magnetic resonance spectroscopy, diffusion-weighted imaging, and dynamic contrast-enhanced MRI, enhance the diagnostic capabilities for prostate cancer by providing detailed information on tissue characteristics and pathophysiology.

These advanced imaging methods are effective for early detection, localization, staging, and identifying recurrent prostate cancer, with potential future applications in assessing tumor aggressiveness and volume.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Multiparametric magnetic resonance imaging of the prostate - technique and clinical applications]. Franiel, T.[2015]

References

1. Ireland pubmed.ncbi.nlm.nih.gov

Diagnostic value of computed high b-value whole-body diffusion-weighted imaging for primary prostate cancer. [2021]

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

What is the optimal b value in diffusion-weighted MR imaging to depict prostate cancer at 3T? [2022]

3. Greece pubmed.ncbi.nlm.nih.gov

Multiparametric MRI Apparent Diffusion Coefficient (ADC) Accuracy in Diagnosing Clinically Significant Prostate Cancer. [2018]

4. Korea (South) pubmed.ncbi.nlm.nih.gov

Comparison of Computed Diffusion-Weighted Imaging b2000 and Acquired Diffusion-Weighted Imaging b2000 for Detection of Prostate Cancer. [2023]

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

Lesion localization in patients with a previous negative transrectal ultrasound biopsy and persistently elevated prostate specific antigen level using diffusion-weighted imaging at three Tesla before rebiopsy. [2009]

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

Novel technique for characterizing prostate cancer utilizing MRI restriction spectrum imaging: proof of principle and initial clinical experience with extraprostatic extension. [2018]

7. England pubmed.ncbi.nlm.nih.gov

Diagnostic value of biparametric magnetic resonance imaging (MRI) as an adjunct to prostate-specific antigen (PSA)-based detection of prostate cancer in men without prior biopsies. [2022]

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

Enhanced dual-stage correlated diffusion imaging. [2020]

9. Germany pubmed.ncbi.nlm.nih.gov

[Multiparametric magnetic resonance imaging of the prostate - technique and clinical applications]. [2015]