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

20 Participants Needed

Trial Summary

What is the purpose of this trial?

Prostate cancer is one of most common cancers in America, affecting 1 in 6 men. External beam radiation therapy is one of the common methods to treat prostate cancer. Although radiotherapy is effective, side effects to the adjacent normal organs limit the therapeutic ratio. Those side effects are usually associated with the radiation damage of the normal tissue surrounding prostate, e.g. bladder, urethra and rectum etc. Both effectiveness and the side effects of radiation treatment are often accessed after whole course of radiotherapy, which makes the early intervention difficult. The current research project is a feasibility study of utilizing advanced magnetic resonance imaging (MRI) techniques to access radiotherapy treatment response of prostate cancer during and right after radiotherapy. Many advanced MRI techniques, e.g. spectroscopy (MRS), diffusion-weighted (DWI), dynamic contrast enhanced (DCE) perfusion weighted images, have been used in radiology departments for diagnostic purpose. This research project is to study the feasibility of using advanced MRI sequences to monitor tissue response during and after radiotherapy. The tissue changes revealed from MRI can provide physicians early information on possible tumor recurrence and normal tissue toxicity, therefore, the early intervention may be possible to spare normal tissue and cure the patient. The project is designed to combine several different advanced MRI imaging techniques systematically to study tissue changes during radiotherapy, which has not been seen elsewhere to date. Another important goal of this research project is to study the feasibility of associating functional MRI with radiation treatment dose distribution. Tissue response during radiation treatment depends on dose. The functional MRI can provide more information than simple anatomic information. Mapping the functional MRI spatially and associating them with 3D dose distribution in radiation treatment planning system is one important step to quantitative assess the relationship between radiation treatment and tissue changes due to the radiation.

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 data supports the effectiveness of MRI imaging as a treatment for prostate cancer?

MRI imaging, especially multiparametric MRI (mpMRI), is effective in managing prostate cancer by improving the detection of significant cancers, aiding in treatment planning, and potentially reducing the need for repeated biopsies. It also helps in assessing the aggressiveness of the cancer, which is crucial for deciding the best treatment approach. ^{1 2 3 4 5}

Is MRI safe for monitoring prostate cancer?

MRI, including multiparametric MRI (mpMRI), is generally considered safe for monitoring prostate cancer. Studies have focused on its use in active surveillance, and while they assess its effectiveness, they do not report significant safety concerns. ^{4 6 7 8 9}

How does MRI monitoring differ from other treatments for prostate cancer?

MRI monitoring for prostate cancer is unique because it uses advanced imaging techniques to track the disease's progression without invasive procedures. This approach can help avoid frequent biopsies and provides detailed information for better treatment planning and follow-up. ^{1 4 10 11 12}

Research Team

Danny Song, M.D.

Principal Investigator

The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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 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]

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]

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]

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 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]

References

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

Multiparametric magnetic resonance imaging in the management and diagnosis of prostate cancer: current applications and strategies. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Prostate cancer imaging. [2022]

3. Germany 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. [2019]

4. Germany pubmed.ncbi.nlm.nih.gov

Multiparametric magnetic resonance imaging can exclude prostate cancer progression in patients on active surveillance: a retrospective cohort study. [2021]

5. England 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. [2015]

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

Temporary Health Impact of Prostate MRI and Transrectal Prostate Biopsy in Active Surveillance Prostate Cancer Patients. [2020]

7. Netherlands 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. [2022]

8. United States 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. [2020]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Magnetic resonance imaging in active surveillance of prostate cancer: a systematic review. [2023]

10. England pubmed.ncbi.nlm.nih.gov

Recent advances in magnetic resonance imaging of prostate cancer. [2021]

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

The role of MRI and MRSI in diagnosis, treatment selection, and post-treatment follow-up for prostate cancer. [2009]

12. Netherlands 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. [2022]