MRI Monitoring for Prostate Cancer

(NA_00067284 Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Danny Song, M.D.

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

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

No Placebo Group

Approved in 1 Jurisdiction

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}

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.

Trial 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 (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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

The Sidney Kimmel Comprehsensive Cancer Center at Johns Hopkins Baltimore, MD

Who Is Running the Clinical Trial?

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Lead Sponsor

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] Magnetic resonance imaging (MRI) has become increasingly used worldwide in the diagnosis and management of prostate cancer. With advances in multiparametric MRI (mpMRI) technology, such as the use of dynamic contrast-enhanced and diffusion-weighted imaging sequences, observational studies have evaluated the utility for mpMRI in the continuum of prostate cancer management, from improving the detection of clinically significant prostate cancer, to planning radical prostatectomy and radiation therapy and the early detection of local recurrence. Furthermore, the potential for advanced imaging to reduce the burden of routine serial prostate needle biopsies for men on active surveillance is a promising area of research. MRI technology continues to evolve, and the potential applications in the management of prostate cancer care will require well-designed multi-institutional prospective clinical trials and rigorous efforts to standardize reporting and improve dissemination of expertise across institutions.

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

Prostate cancer imaging. [2022] As prostate cancer is a biologically heterogeneous disease for which a variety of treatment options are available, the major objective of prostate cancer imaging is to achieve more precise disease characterization. Magnetic resonance imaging (MRI) may enhance the staging of prostate cancer compared with clinical evaluation, transrectal ultrasound, or computed tomography (CT), and allows concurrent evaluation of prostatic, periprostatic, and pelvic anatomy. In clinical practice, the fusion of MRI or dynamic contrast-enhanced MRI (DCE-MRI) with MR spectroscopic imaging (MRSI) is improving the evaluation of cancer location, size, and extent, while providing an indication of tumor aggressiveness. Pretreatment knowledge of these prognostic variables is essential for achieving minimally invasive, patient-specific therapy.

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] Multiparametric-magnetic resonance imaging (mpMRI) can accurately detect high-grade and larger prostate cancers (PC).

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] To assess the ability of multiparametric MRI (mp-MRI) of the prostate to exclude prostate cancer (PCa) progression during monitoring patients on active surveillance (AS).

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] Clinical management of prostate cancer increasingly aims to distinguish aggressive types that require immediate and radical treatment from indolent tumors that are candidates for watchful waiting. This requires reliable and reproducible parameters to effectively control potential cancer progression. Magnetic resonance imaging (MRI) may provide a non-invasive means for this purpose.

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] To assess the temporary health impact of prostate multiparametric MRI (mpMRI) and transrectal prostate biopsy in an active surveillance prostate cancer population.

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] The role of multiparametric magnetic resonance imaging (mp-MRI) during active surveillance (AS) of prostate cancer needs evaluation. It remains unclear whether mp-MRI can replace prostate biopsies completely during AS.

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] Prospective studies are lacking in assessing the diagnostic utility of serial multiparametric magnetic resonance imaging to predict biopsy proven progression to clinically significant prostate cancer in men on active surveillance, as well as the oncologic safety of baseline magnetic resonance imaging and saturation diagnostic biopsy in replacing early confirmatory biopsy during active surveillance.

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

Magnetic resonance imaging in active surveillance of prostate cancer: a systematic review. [2023] There is great interest in using magnetic resonance imaging (MRI) for men on active surveillance for prostate cancer.

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

Recent advances in magnetic resonance imaging of prostate cancer. [2021] This concise review attempts to highlight the recent advances in magnetic resonance imaging (MRI) in relation to all the different aspects of prostate cancer (PCa), and outlines future implications of MRI in the diagnosis, treatment, and surveillance of PCa.

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] Magnetic resonance imaging (MRI) is increasingly being recognized as a valuable tool for the assessment of prostate cancer. In recent years, MRI technology has matured, image acquisition and interpretation have improved, and a multitude of clinical studies have demonstrated the potential of MRI techniques for contributing to prostate cancer care. This review will provide a brief overview of MRI techniques relevant to prostate cancer, including MR spectroscopic imaging, and discuss the ways that they can aid in diagnosis, treatment selection, and post-treatment follow-up.

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] Multiparametric magnetic resonance imaging (MRI) is increasingly utilized to improve the detection of clinically significant prostate cancer. Evidence for serial MRI in men on active surveillance (AS) is lacking.