3-Tesla MRI for Prostate Cancer

Overseen By Michael Knopp, MD

Age: Any Age

Sex: Male

Trial Phase: Academic

Sponsor: University of Cincinnati

Disqualifiers: Bioimplants, Metallic implants, Claustrophobia, Renal insufficiency, others

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

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a more comfortable method for performing MRIs on individuals with prostate issues. Typically, a 1.5 Tesla MRI with an internal coil is used. However, this trial employs a stronger 3 Tesla MRI with an external coil, aiming to provide clearer images without the discomfort of an internal coil. The goal is to enable doctors to make better treatment decisions using these improved images. Individuals diagnosed with prostate disease or at high risk, such as those with certain cancer grades, may be suitable candidates for this trial. As an unphased trial, it offers participants the chance to contribute to advancements in MRI technology, potentially leading to more comfortable and accurate diagnostic options.

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's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this 3-Tesla MRI is safe for prostate cancer imaging?

Research has shown that a 3-Tesla MRI, a scan with a strong magnet, is safe and easy for patients to handle. Studies have found that this method can effectively detect prostate cancer without an endorectal coil, making it less invasive and more comfortable. No significant side effects or safety issues have been reported in the available studies on 3-Tesla MRI. This suggests the procedure is generally safe for those considering joining a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using 3-Tesla MRI for prostate cancer because it offers a detailed and non-invasive way to assess the condition. Unlike traditional imaging methods like ultrasound or lower strength MRI machines, 3T MRI provides higher resolution images, which can help in precisely identifying and characterizing prostate tumors. This advanced imaging technique includes dynamic contrast-enhanced MRI, diffusion-weighted imaging, and MR spectroscopy, allowing for a comprehensive evaluation of the prostate. These features could lead to more accurate diagnoses and better treatment planning for patients.

What evidence suggests that 3-Tesla MRI is effective for prostate cancer imaging?

Research has shown that a 3-Tesla MRI, which participants in this trial will undergo, effectively detects prostate cancer. Studies indicate that this MRI type can accurately identify significant prostate cancers without requiring an uncomfortable endorectal coil. Specifically, a 3-Tesla MRI provides clearer and more detailed images than the standard 1.5-Tesla MRI. These enhanced images assist doctors in making more informed treatment decisions. Overall, a 3-Tesla MRI is a promising tool for the early and accurate detection of prostate cancer. ^{1 3 6 7 8}

Who Is on the Research Team?

Michael Knopp, MD

Principal Investigator

Ohio State University

Are You a Good Fit for This Trial?

This trial is for patients with known or suspected prostate cancer, specifically those with a Gleason's score >= 7 and PSA > 10ng/dl. Participants must have proper kidney function (eGFR >= 30 mL/min/1.73m^2). They should be able to follow the study procedures and communicate effectively. Those with severe renal issues, bioimplants like pacemakers, metal in their body, or extreme anxiety are excluded.

Inclusion Criteria

I have prostate cancer with a Gleason score of 7 or higher and a PSA over 10ng/dl.

I will sign a consent form before getting an MRI as per Ohio State University's rules.

My kidney function test shows a filtration rate of at least 30 mL/min.

Exclusion Criteria

I have metal clips or staples from surgery in my body.

I experience significant anxiety or claustrophobia.

I have heart problems or issues with blood circulation and sweating.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging

Participants undergo 3T MRI, including DCE-MRI, diffusion-weighted MRI, amide-proton-transfer MRI, and MR spectroscopy scans. An additional 3T MRI scan may be performed at least 24 hours after the initial scan.

1-2 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after imaging procedures

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• 3-Tesla magnetic resonance imaging (3T MRI)
• diffusion-weighted magnetic resonance imaging
• dynamic contrast-enhanced magnetic resonance imaging
• magnetic resonance spectroscopic imaging

Trial Overview The trial tests if using a stronger magnet (3 Tesla MRI) without an uncomfortable internal coil can still provide clear images of the prostate for better treatment planning. It compares this method against standard imaging practices to see if it offers more comfort without compromising image quality.

How Is the Trial Designed?

Group I: Diagnostic (3T MRI) Experimental Treatment 4 Interventions

Patients undergo 3T MRI, including DCE-MRI, diffusion-weighted MRI, amide-proton-transfer MRI, and MR spectroscopy scans. Patients may undergo an additional 3T MRI scan at least 24 hours after the initial scan.

Who Is Running the Clinical Trial?

University of Cincinnati

Lead Sponsor

Trials

442

Recruited

639,000+

Ohio State University Comprehensive Cancer Center

Lead Sponsor

Trials

350

Recruited

295,000+

Published Research Related to This Trial

In a study of 429 patients undergoing 3 Tesla multiparametric MRI before prostatectomy, the use of an endorectal coil did not significantly improve overall prostate cancer detection rates compared to MRI without the coil, with detection rates of 50.5% and 48.2%, respectively.

However, the endorectal coil significantly enhanced the detection of posterior and peripheral prostate cancers, while it was less effective for anterior and transition zone lesions, indicating that the choice of imaging method may influence the detection of specific cancer locations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Three Tesla Multiparametric Magnetic Resonance Imaging: Comparison of Performance with and without Endorectal Coil for Prostate Cancer Detection, PI-RADS™ version 2 Category and Staging with Whole Mount Histopathology Correlation. Mirak, SA., Shakeri, S., Bajgiran, AM., et al.[2019]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5066885/

Prostate cancer detection using multiparametric 3 – tesla MRI ... Our results show that 3 Tesla mpMRI without an endorectal coil is a non-invasive technique that helps to detect clinically significant PCa, with high ...

2. ejrnm.springeropen.com ejrnm.springeropen.com/articles/10.1186/s43055-024-01244-9

3T multiparametric MRI's accuracy in detecting prostate ... 1 for detecting prostate cancer, with prostate biopsy as a reference. Our findings indicated that at a cutoff point of a PIRADS score of 5, the ...

3. ajronline.org ajronline.org/doi/10.2214/AJR.06.1329

Dynamic Contrast-Enhanced MRI of Prostate Cancer at 3 T CONCLUSION. MRI of the prostate performed at 3 T using an endorectal coil produces high-quality T2-weighted images; however, specificity for prostate cancer is ...

4. nejm.org nejm.org/doi/full/10.1056/NEJMoa1910038

MRI-Targeted, Systematic, and Combined Biopsy for ... Among the 404 men who underwent subsequent radical prostatectomy, combined biopsy was associated with the fewest upgrades to grade group 3 or ...

5. urotoday.com urotoday.com/library-resources/prostate-cancer-active-surveilance/111528-prostate-cancer-and-utilization-of-multi-parametric-mri.html

Prostate Cancer and Utilization of Multi-Parametric MRI Over the last decade, imaging for prostate cancer has improved immensely. Specifically, prostate multiparametric MRI (mpMRI) has improved ...

6. jamanetwork.com jamanetwork.com/journals/jamaoncology/fullarticle/2827887

Oncological Safety of MRI-Informed Biopsy Decision ... After 3 years of programmatic monitoring, clinically significant prostate cancer was detected in 4% of men with negative MRI results who ...

7. ajronline.org ajronline.org/doi/10.2214/AJR.24.32588

MRI in Prostate Cancer Screening: A Review and ... In STHLM3-MRI trial, in standard-of-care MRI pathway, 21% of men had PCa graded as GG 2 or higher, and 4% had GG 1 cancer, leading to ratio of 4.7 for cancer of ...

8. auanet.org auanet.org/guidelines-and-quality/guidelines/other-clinical-guidance/mri-of-the-prostate-sop

Prostate Cancer The authors concluded that MRI had a 66.7% positive predictive value for patients with a normal PSA and a PI-RADS lesion >4 and a negative predictive value of ...