MRI for Prostate Cancer

Recruiting at 48 trial locations

Overseen By Pablo R. Ros

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: ECOG-ACRIN Cancer Research Group

Disqualifiers: Claustrophobia, Metallic objects, Renal failure, 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

852 Participants Needed

Trial Summary

What is the purpose of this trial?

This phase II trial studies how well multiparametric magnetic resonance imaging (MRI) works in evaluating cancer stage and helping treatment planning in patients with prostate cancer. Multiparametric MRI may be useful for evaluating the type of cancer in finding aggressive disease.

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

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

What data supports the effectiveness of the treatment Multiparametric Magnetic Resonance Imaging (mpMRI) for prostate cancer?

Research shows that mpMRI is effective in accurately locating prostate cancer, improving risk assessment, and aiding in treatment decisions. It helps in diagnosing, staging, and evaluating treatment responses, making it a valuable tool in managing prostate cancer. ^{1 2 3 4 5}

Is multiparametric MRI safe for humans?

The research articles do not provide specific safety data for multiparametric MRI, but it is widely used in prostate cancer detection and monitoring, suggesting it is generally considered safe. ^{6 7 8 9 10}

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

Multiparametric MRI (mpMRI) is unique because it is a non-invasive imaging technique that provides detailed functional information about the prostate, helping to accurately distinguish between benign and malignant lesions. Unlike other treatments, it serves as a highly effective diagnostic tool, improving the localization of prostate cancer and aiding in better clinical decision-making. ^{1 3 11 12 13}

Research Team

Clare Tempany-Afdhal

Principal Investigator

ECOG-ACRIN Cancer Research Group

Eligibility Criteria

This trial is for men recently diagnosed with prostate cancer who are candidates for definitive surgery. It's not open to those who've had previous treatments for prostate cancer, major pelvic surgeries like hip replacements, or can't have an MRI due to severe claustrophobia, certain metal implants, kidney failure, or exceeding the scanner's weight limit.

Inclusion Criteria

I have recently been diagnosed with prostate cancer and need surgery.

Exclusion Criteria

I cannot have an MRI due to severe claustrophobia, metal implants, kidney issues, or exceeding the weight limit.

I have had treatment for prostate cancer before.

I have had a hip replacement or major surgery in my pelvic area.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Diagnostic

Patients undergo multiparametric MRI (mpMRI) within 3 months prior to scheduled surgery to evaluate cancer stage and assist in treatment planning

12 weeks

Follow-up

Participants are monitored until radical prostatectomy pathology is reported and finalized

Up to 2 years

Treatment Details

Interventions

• Multiparametric Magnetic Resonance Imaging

Trial Overview The study is testing how well a type of advanced imaging called multiparametric MRI works in assessing the stage of prostate cancer and aiding in treatment planning. The goal is to see if this MRI technique can better identify aggressive types of prostate cancer.

Participant Groups

Group I: Diagnostic (mpMRI) Experimental Treatment 1 Intervention

Patients undergo mpMRI within 3 months prior to schedule surgery.

Multiparametric Magnetic Resonance Imaging is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Multiparametric MRI for:

• Prostate cancer staging
• Prostate cancer treatment planning
• Active surveillance of low-risk prostate cancer

Approved in United States as Multiparametric MRI for:

• Prostate cancer detection
• Prostate cancer staging
• Prostate cancer treatment planning
• Active surveillance of low-risk prostate cancer

Approved in Canada as Multiparametric MRI for:

• Prostate cancer detection
• Prostate cancer staging
• Prostate cancer treatment planning

Who Is Running the Clinical Trial?

ECOG-ACRIN Cancer Research Group

Lead Sponsor

Trials

122

Recruited

160,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

Multiparametric magnetic resonance imaging (mpMRI) significantly enhances the detection of clinically significant prostate cancer (csPCa) during biopsy, as shown by a study of 40 patients where 20% were diagnosed with PCa.

The use of mpMRI improved the decision-making process for biopsies, with an area under the curve (AUC) of 0.771 indicating good diagnostic performance, allowing for better patient management by identifying those who may not need a biopsy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Detection of individual prostate cancer via multiparametric magnetic resonance imaging in own material - initial experience. Porzycki, P., Ciszkowicz, E.[2022]

Multi-parametric MRI (mpMRI) is an effective tool for detecting and staging early prostate cancer, with a high negative predictive value of 95% for significant cancer when results are normal, making it a reliable option before biopsy.

mpMRI enhances treatment planning by guiding targeted therapies and surgical options, and its high spatial resolution allows for detailed assessment of disease spread, including extra-capsular extension and involvement of nearby structures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of multi-parametric MRI in loco-regional staging of men diagnosed with early prostate cancer. Appayya, MB., Johnston, EW., Punwani, S.[2015]

Multiparametric MRI (mpMRI) is a crucial tool for diagnosing and managing prostate cancer, showing significant growth and acceptance in the medical field over the past decade.

As the demand for prostate mpMRI increases globally, there is a pressing need to train specialized imagers to ensure high-quality imaging results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Education of prostate MR imaging: commentary. Merritt, BA., Behr, SC.[2021]

A novel risk model (EPE-RM) that combines clinical parameters and multiparametric MRI (mpMRI) data was developed and showed a high accuracy (ROC area under the curve of 0.87) in predicting extraprostatic extension (EPE) in prostate cancer patients, outperforming existing clinical models and MRI predictors.

The EPE-RM included significant predictors such as biopsy grade, ESUR criteria, prostate-specific antigen levels, and capsule contact length, providing a more tailored preoperative risk assessment for patients undergoing nerve-sparing radical prostatectomy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combined Clinical Parameters and Multiparametric Magnetic Resonance Imaging for the Prediction of Extraprostatic Disease-A Risk Model for Patient-tailored Risk Stratification When Planning Radical Prostatectomy. Nyarangi-Dix, J., Wiesenfarth, M., Bonekamp, D., et al.[2021]

Multi-parametric prostate MRI (mpMRI) is essential for accurately diagnosing and staging prostate cancer, which helps in determining the appropriate treatment for patients.

Standardized interpretation of mpMRI by radiologists aids in risk stratification, allowing for better decision-making regarding invasive treatments and preventing unnecessary overtreatment in patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prostate MRI: staging and decision-making. Magnetta, MJ., Catania, R., Girometti, R., et al.[2021]

From 2008 to 2013, the use of multiparametric magnetic resonance imaging (mpMRI) in active surveillance for prostate cancer among male Medicare beneficiaries increased significantly, with 14% of men receiving mpMRI during this period.

Factors influencing the likelihood of receiving mpMRI included being younger, white, having lower comorbidity, living in urban areas, and higher income, indicating disparities in access to this imaging technology that warrant further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Increasing Utilization of Multiparametric Magnetic Resonance Imaging in Prostate Cancer Active Surveillance. Fam, MM., Yabes, JG., Macleod, LC., et al.[2020]

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]

Multiparametric magnetic resonance imaging (mpMRI) can enhance the risk assessment for men with prostate cancer considering active surveillance (AS) by effectively visualizing high-grade tumors, which may lead to better patient selection compared to standard biopsy methods.

The high negative predictive value of mpMRI allows for the possibility of avoiding unnecessary repeat biopsies, while the presence of a positive lesion on mpMRI can indicate a higher risk of disease progression during AS, highlighting its role in monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of multiparametric magnetic resonance imaging in prostate cancer active surveillance. Glass, AS., Dall'Era, MA.[2020]

Multiparametric MRI of the prostate at 7 T is technically feasible, achieving high-resolution imaging in 13 out of 14 patients with prostate cancer, indicating potential for improved anatomical delineation.

While the image quality was generally rated as fair to good, challenges such as motion artifacts and signal-to-noise ratio issues need to be addressed before 7 T mpMRI can be widely adopted in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of Multiparametric Magnetic Resonance Imaging of the Prostate at 7 T. Lagemaat, MW., Philips, BW., Vos, EK., et al.[2018]

Multiparametric MRI (mpMRI) is now the primary imaging method for detecting and staging prostate cancer, highlighting its importance in clinical practice.

For accurate and reliable reporting of prostate mpMRI, radiologists must understand the anatomy, pathology, and potential pitfalls that can affect the imaging results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What You Need to Know Before Reading Multiparametric MRI for Prostate Cancer. Walker, SM., Choyke, PL., Turkbey, B.[2020]

The use of multiparametric MRI (mpMRI) for prostate cancer diagnosis and management increased by 486% over 26 months, indicating a rapid adoption of this non-invasive screening tool among clinicians.

mpMRI is primarily used for abnormal screening results (64% of cases), with a significant number of patients (47%) proceeding to biopsy, showcasing its role in guiding clinical decisions and improving patient management in prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dramatic increase in the utilization of multiparametric magnetic resonance imaging for detection and management of prostate cancer. Oberlin, DT., Casalino, DD., Miller, FH., et al.[2022]

Biparametric MRI (bpMRI) has shown comparable diagnostic accuracy to multiparametric MRI (mpMRI) for detecting prostate cancer, offering advantages such as lower costs, reduced acquisition time, and fewer side effects due to the absence of contrast agents.

However, the effectiveness of bpMRI may be limited in general community settings, as most studies come from specialized centers, and there is a need for further research, including prospective multicenter studies, to validate its clinical application for early prostate cancer detection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The future direction of imaging in prostate cancer: MRI with or without contrast injection. Pecoraro, M., Messina, E., Bicchetti, M., et al.[2022]

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]

References

1. Poland pubmed.ncbi.nlm.nih.gov

Detection of individual prostate cancer via multiparametric magnetic resonance imaging in own material - initial experience. [2022]

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

The role of multi-parametric MRI in loco-regional staging of men diagnosed with early prostate cancer. [2015]

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

Education of prostate MR imaging: commentary. [2021]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Combined Clinical Parameters and Multiparametric Magnetic Resonance Imaging for the Prediction of Extraprostatic Disease-A Risk Model for Patient-tailored Risk Stratification When Planning Radical Prostatectomy. [2021]

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

Prostate MRI: staging and decision-making. [2021]

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

Increasing Utilization of Multiparametric Magnetic Resonance Imaging in Prostate Cancer Active Surveillance. [2020]

7. Germany pubmed.ncbi.nlm.nih.gov

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

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

Use of multiparametric magnetic resonance imaging in prostate cancer active surveillance. [2020]

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

Feasibility of Multiparametric Magnetic Resonance Imaging of the Prostate at 7 T. [2018]

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

What You Need to Know Before Reading Multiparametric MRI for Prostate Cancer. [2020]

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

Dramatic increase in the utilization of multiparametric magnetic resonance imaging for detection and management of prostate cancer. [2022]

12. England pubmed.ncbi.nlm.nih.gov

The future direction of imaging in prostate cancer: MRI with or without contrast injection. [2022]

13. Austria pubmed.ncbi.nlm.nih.gov

Short review of biparametric prostate MRI. [2020]