MRI Monitoring for Prostate Cancer

(NA_00067284 Trial)

Overseen By Danny Song, M.D.

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Disqualifiers: MRI incompatible, Gadolinium allergy, Pacemaker, Kidney disease

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if advanced MRI techniques (Magnetic Resonance Imaging) can effectively monitor prostate cancer's response to radiation therapy. By employing these MRI techniques during and after treatment, doctors aim to detect early tissue changes, potentially reducing side effects and improving outcomes. The trial combines various MRI methods to provide a clearer picture of radiation's effects on both cancer and nearby healthy tissues. Men diagnosed with prostate cancer and planning to undergo radiation treatment might be suitable candidates for this study. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance future prostate cancer treatments.

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 these MRI techniques are safe for monitoring prostate cancer treatment?

Research shows that magnetic resonance imaging (MRI) is generally easy for patients to handle in medical settings. Studies have found that MRI can help diagnose prostate cancer by identifying potentially cancerous areas, aiding doctors in selecting the best treatment options.

MRI avoids the side effects associated with radiation, as it does not use it. In terms of safety, MRI is considered very safe for most people. However, some individuals might feel uncomfortable in the MRI machine due to its enclosed nature and loud noises.

Overall, MRI is a common and safe tool used in hospitals and clinics. It has been employed for many years to help doctors visualize the body's interior and develop better treatment plans. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the use of MRI imaging for monitoring prostate cancer because it offers a non-invasive way to closely track the cancer's response to standard radiation treatment. Unlike traditional methods that might rely heavily on periodic biopsies or PSA tests alone, MRI provides detailed images of the prostate, allowing for more precise monitoring. This technique could lead to more personalized treatment plans by identifying changes in the tumor more quickly and accurately, potentially improving outcomes for patients.

What evidence suggests that MRI imaging is effective for monitoring prostate cancer treatment?

Research has shown that MRI scans reliably detect prostate cancer. Studies have found that MRI can accurately identify cancerous tissue, even when PSA results are unclear. MRI also helps predict if further treatment might be necessary. New advances, such as computer programs used with MRI, have shown promise in distinguishing between non-cancerous and cancerous tumors with high accuracy. In this trial, participants will receive MRI imaging alongside standard radiation treatment. By employing these advanced MRI methods during radiation therapy, doctors may catch early signs of issues and adjust treatments to protect healthy tissues. ^{3 6 7 8 9}

Who Is on the Research Team?

Danny Song, M.D.

Principal Investigator

The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Are You a Good Fit for This Trial?

This trial is for men with confirmed prostate cancer who are planning to receive external radiation treatment. It's not suitable for those with a cardiac pacemaker, metal implants, chronic kidney disease, an inability to undergo MRI scans, or allergies to gadolinium-based contrast agents.

Inclusion Criteria

My prostate cancer diagnosis was confirmed through a tissue examination.

I am planning to receive external radiation for prostate cancer.

Exclusion Criteria

You are unable to have an MRI scan.

You have a heart pacemaker or other electronic/metal implant in your body.

I have chronic kidney disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline MRI and Treatment Planning

First MRI scan conducted prior to radiation treatment during patient simulation for baseline information and treatment planning

1 day

1 visit (in-person)

Radiation Treatment with Mid-course MRI

Participants undergo routine radiation treatment with a second MRI scan conducted mid-course

6-8 weeks

Daily visits for radiation treatment, 1 additional MRI scan

End of Treatment MRI

Third MRI scan conducted at the end of radiation treatment to assess treatment response

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including routine follow-up data collection on tumor response and normal tissue toxicity

2 months

What Are the Treatments Tested in This Trial?

Interventions

• MRI imaging

Trial Overview The study is testing the use of advanced MRI techniques like MRS, DWI, and DCE during and after radiotherapy to monitor tissue response in prostate cancer patients. The goal is to see if these MRIs can provide early information on tumor recurrence and normal tissue damage.

How Is the Trial Designed?

Group I: MRI imaging Experimental Treatment 1 Intervention

Use of MRI imaging in conjunction with standard radiation treatment

Who Is Running the Clinical Trial?

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Lead Sponsor

Trials

578

Recruited

33,600+

Published Research Related to This Trial

In a study of 125 men on active surveillance for low-risk prostate cancer, serial multiparametric MRI improved the detection of clinically significant disease, with sensitivity for Gleason grade group ≥2 increasing from 85% to 91% between initial and follow-up scans.

An increase in PI-RADS scores from the first to the second MRI was strongly associated with a higher likelihood of biopsy upgrade to Gleason grade group ≥2 and a greater chance of receiving definitive treatment, highlighting the importance of monitoring changes in MRI findings over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diagnostic Accuracy and Prognostic Value of Serial Prostate Multiparametric Magnetic Resonance Imaging in Men on Active Surveillance for Prostate Cancer. Chu, CE., Cowan, JE., Lonergan, PE., et al.[2022]

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]

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]

Multiparametric MRI (mpMRI) significantly enhances the detection and management of clinically significant prostate cancer, aiding in treatment planning and early detection of recurrence.

The evolving MRI technology may reduce the need for routine prostate needle biopsies in men under active surveillance, highlighting the importance of further research and standardized practices in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multiparametric magnetic resonance imaging in the management and diagnosis of prostate cancer: current applications and strategies. Lee, DJ., Ahmed, HU., Moore, CM., et al.[2022]

1. The study found that 1.5T mpMRI can effectively identify high-grade prostate cancers, with a positive predictive value of 45% and a negative predictive value of 82%, indicating its utility in guiding prostate biopsies.

2. In patients with a normal mpMRI, 81.8% were negative for clinically significant cancer at biopsy, suggesting that targeted biopsies alone may miss significant cancers in about 50% of cases, highlighting the importance of combining mpMRI with saturation biopsies for accurate diagnosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does 1.5 T mpMRI play a definite role in detection of clinically significant prostate cancer? Findings from a prospective study comparing blind 24-core saturation and targeted biopsies with a novel data remodeling model. Dal Moro, F., Zecchini, G., Morlacco, A., et al.[2019]

MRI can effectively detect clinically significant prostate cancer in about two-thirds of men who are candidates for active surveillance, making it a valuable tool for initial assessments.

However, there is currently insufficient data on the use of repeat MRI for ongoing monitoring during active surveillance, highlighting the need for further studies to establish clear definitions of what constitutes significant disease and progression on MRI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnetic resonance imaging in active surveillance of prostate cancer: a systematic review. Schoots, IG., Petrides, N., Giganti, F., et al.[2023]

In a study of 172 men with low-risk prostate cancer on active surveillance, the use of serial multiparametric magnetic resonance imaging (MRI) effectively detected disease progression, with 21% showing pathological progression within 3 years.

The MRI demonstrated a high negative predictive value (89%) and reasonable sensitivity (61%) for identifying clinically significant prostate cancer, suggesting it could help defer confirmatory biopsies, although it should not completely replace the 3-year biopsy due to the risk of missing some tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Magnetic Resonance Imaging in Active Surveillance (MRIAS) Trial: Use of Baseline Multiparametric Magnetic Resonance Imaging and Saturation Biopsy to Reduce the Frequency of Surveillance Prostate Biopsies. Amin, A., Scheltema, MJ., Shnier, R., et al.[2020]

Recent advances in magnetic resonance imaging (MRI) have significantly improved the diagnosis and treatment of prostate cancer, enhancing the ability to detect and monitor the disease.

The review discusses future implications of MRI technology, suggesting it will play a crucial role in the ongoing surveillance and management of prostate cancer, potentially leading to better patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recent advances in magnetic resonance imaging of prostate cancer. Lawrentschuk, N., Lindner, U.[2021]

MRI has become an important tool in assessing prostate cancer, with advancements in technology leading to better image quality and interpretation.

Various MRI techniques, including MR spectroscopic imaging, can significantly enhance diagnosis, treatment selection, and monitoring after treatment for prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of MRI and MRSI in diagnosis, treatment selection, and post-treatment follow-up for prostate cancer. Fuchsjäger, M., Akin, O., Shukla-Dave, A., et al.[2009]

In a study of 39 patients undergoing MRI before prostate surgery, the normalized apparent diffusion coefficient (nADC) was found to be highly effective in distinguishing between aggressive and indolent prostate cancer, with an area under the curve (AUC) of 0.90.

Combining nADC with the choline/citrate ratio (CCC) improved the accuracy of predicting tumor aggressiveness, achieving correct identification in 85% of cases, which is comparable to results from traditional biopsy methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Non-invasive estimation of prostate cancer aggressiveness using diffusion-weighted MRI and 3D proton MR spectroscopy at 3.0 T. Thörmer, G., Otto, J., Horn, LC., et al.[2015]

Multiparametric magnetic resonance imaging (mp-MRI) shows moderate sensitivity (61%) and specificity (78%) for detecting disease progression in prostate cancer patients on active surveillance, based on a systematic review of 7 studies involving 800 patients.

Current evidence does not support replacing prostate biopsies with mp-MRI in active surveillance protocols, highlighting the need for institutions to evaluate their own mp-MRI diagnostic performance rather than relying solely on international guidelines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can the Use of Serial Multiparametric Magnetic Resonance Imaging During Active Surveillance of Prostate Cancer Avoid the Need for Prostate Biopsies?-A Systematic Diagnostic Test Accuracy Review. Hettiarachchi, D., Geraghty, R., Rice, P., et al.[2022]

Magnetic resonance imaging (MRI) significantly improves the staging and characterization of prostate cancer compared to traditional methods like clinical evaluation and CT scans, allowing for better assessment of tumor location and extent.

The combination of MRI with dynamic contrast-enhanced MRI (DCE-MRI) and MR spectroscopic imaging (MRSI) provides critical prognostic information that can guide personalized and minimally invasive treatment strategies for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prostate cancer imaging. Fuchsjäger, M., Shukla-Dave, A., Akin, O., et al.[2022]

Citations

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Five-year Outcomes of Magnetic Resonance Imaging–based ... Magnetic resonance imaging (MRI)-visible cancer at baseline, along with 3 + 4 Gleason grade, predicts a greater likelihood of treatment at five years.

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Prostate Cancer A Comparison of Magnetic Resonance ... The aim of this study is to compare magnetic resonance imaging (MRI) assessments and biopsy outcomes with and without a central review in two Swedish OPT ...

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Cost-Effectiveness of Annual Prostate MRI and Potential ... This economic evaluation compares the cost-effectiveness of integrating annual magnetic resonance imaging and potential magnetic resonance ...

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Machine learning-based MRI imaging for prostate cancer ... The results showed that machine learning models performed exceptionally well in prostate cancer benign/malignant diagnosis (combined AUC = 0.96) ...

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Diagnostic performance of MRI in detecting prostate cancer in ... Prostate MRI can be considered a reliable and satisfactory tool for detecting csPCa and PCa in patients with PSA in the “gray zone”, allowing for reducing ...

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Oncological Safety of MRI-Informed Biopsy Decision ... This cohort study assesses the feasibility and safety of a community-based magnetic resonance imaging (MRI) diagnostic strategy in men with suspected prostate ...

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

Prostate Cancer The MRI score has been shown to be the single most important determinant of prostate cancer risk. In a prospective study of 1,042 men who underwent mpMRI ...

8. nejm.org nejm.org/doi/full/10.1056/NEJMoa2100852

MRI-Targeted or Standard Biopsy in Prostate Cancer ... Magnetic resonance imaging (MRI) has generated interest as a method for improving prostate cancer diagnostics. MRI can identify areas of the prostate suggestive ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8988779/

The utility of magnetic resonance imaging in prostate ... However, MRI has a false negative rate of 6.5% overall for clinically significant prostate cancers. Pre‐ biopsy MRI may reduce the number of unnecessary ...