MRI for Prostate Cancer

Not currently recruiting at 54 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of a special type of MRI, a detailed imaging test, in assessing the stage of prostate cancer and planning treatment. The focus is on multiparametric MRI, which may help identify aggressive cancer types and guide treatment decisions. Men recently diagnosed with prostate cancer and planning surgery might be suitable candidates for this trial. However, it is not suitable for those unable to undergo an MRI or those who have had previous prostate cancer treatments or major pelvic surgeries. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance future prostate cancer diagnostics and treatment planning.

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 prior data suggests that multiparametric MRI is safe for evaluating prostate cancer?

Studies have shown that multiparametric MRI (mpMRI) safely checks for prostate cancer. MpMRI employs various imaging methods to create detailed pictures of the prostate, aiding doctors in understanding the cancer's stage and planning treatment.

Research indicates that mpMRI avoids harmful radiation, unlike some other imaging tests, making it a well-tolerated option for patients. The procedure is non-invasive, meaning it doesn't involve surgery or entering the body.

Additionally, mpMRI is already widely used for diagnosing and managing prostate cancer, enhancing its safety record. While no procedure is completely risk-free, current evidence supports mpMRI as a safe choice for patients considering its use in clinical trials. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using multiparametric magnetic resonance imaging (mpMRI) for prostate cancer diagnosis because it offers a more detailed view of the prostate compared to traditional imaging techniques. Unlike standard options like ultrasound or single-parametric MRI, mpMRI combines multiple imaging sequences to provide a comprehensive picture of the prostate, potentially improving the accuracy of cancer detection and characterization. This method allows doctors to better differentiate between aggressive and non-aggressive tumors, which could lead to more personalized and effective treatment plans for patients.

What evidence suggests that multiparametric MRI is effective for evaluating prostate cancer?

Research has shown that a special type of MRI scan, called multiparametric MRI (mpMRI), effectively finds and evaluates prostate cancer. Studies indicate that mpMRI detects significant prostate cancer in 33% of cases, compared to 24% with biopsy alone. In this trial, participants will undergo mpMRI within 3 months before scheduled surgery. This scan helps pinpoint the cancer's location and assess its aggressiveness, which is crucial for planning treatment. Additionally, using mpMRI alongside other tests may help reduce deaths from prostate cancer. Overall, mpMRI serves as a valuable tool for better diagnosing and managing prostate cancer. ^{1 4 6 7 8}

Who Is on the Research Team?

Clare Tempany-Afdhal

Principal Investigator

ECOG-ACRIN Cancer Research Group

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 (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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4495493/

Multiparametric-MRI in diagnosis of prostate cancer - PMC Multiparametric-magnetic resonance imaging (mp-MRI) has shown promising results in diagnosis, localization, risk stratification and staging of clinically ...

2. ascopubs.org ascopubs.org/doi/10.1200/JCO.2021.39.6_suppl.224

Effectiveness of early diagnosis for prostate cancer based ... Using mpMRI was estimated to result in an additional 126 and 118 fewer deaths per 100,000 if mpMRI was used in conjunction with SB (S2) or with ...

3. dirjournal.org dirjournal.org/articles/long-term-follow-up-results-of-multiparametric-prostate-mri-and-the-prognostic-value-of-pi-rads-a-single-center-retrospective-cohort-study/dir.2023.232414

Long-term follow-up results of multiparametric prostate MRI ... We aim to examine the long-term outcomes of patients who underwent multiparametric prostate magnetic resonance imaging (mp-MRI) for suspected prostate cancer ( ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S107814392400485X

mpMRI in prostate cancer screening and diagnosis This contemporary review evaluates the most recent literature on the role of mpMRI in the screening and diagnosis of prostate cancer.

5. aafp.org aafp.org/pubs/afp/issues/2022/0600/p665.html

Multiparametric MRI for the Evaluation of Prostate Cancer By targeting suspicious areas of the prostate, the median rate of significant prostate cancer detection was 33% with mpMRI vs. 24% with biopsy alone. The ...

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

Prostate Cancer Multi-parametric MRI (mpMRI) has been proven to be a valuable tool in the diagnostic and management pathway in men at risk of prostate cancer.

8. sciencedirect.com sciencedirect.com/science/article/pii/S0302283819308231

Multiparametric Magnetic Resonance Imaging for the ... This paper shows the correlation between (ab)normal prostate anatomical structures and image characteristics on mpMRI, and how standardized interpretation