RSI MRI Monitoring for Prostate Cancer

(ProsRSI Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Tyler Seibert, MD, PhD

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: University of California, San Diego

Must be taking: Androgen deprivation

Disqualifiers: Prior radiotherapy, Hip prosthesis, others

No Placebo Group

Prior Safety Data

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

Adult male patients with high-risk, localized prostate cancer and planning to undergo radiation therapy (RT) with androgen deprivation therapy (ADT) will undergo an advanced Magnetic Resonance Imaging (MRI) examination called Restriction Spectrum Imaging (RSI-MRI) to evaluate whether RSI-MRI can predict treatment response.

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

The trial protocol does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

What data supports the effectiveness of the treatment RSI-MRI for prostate cancer?

Research shows that RSI-MRI can improve the detection and grading of prostate cancer compared to standard MRI techniques. It provides a more accurate way to distinguish between cancerous and non-cancerous tissue, which is crucial for better diagnosis and treatment planning. ^{1 2 3 4 5}

Is RSI-MRI safe for humans?

The research articles provided do not specifically address the safety of RSI-MRI, but MRI techniques, in general, are considered noninvasive and safe for human use. ^{1 3 4 5 6}

How is the RSI-MRI treatment different from other prostate cancer treatments?

RSI-MRI is a unique imaging technique that enhances the detection and characterization of prostate cancer by using advanced diffusion-weighted MRI to highlight tissue microarchitecture, providing more detailed and accurate imaging compared to standard MRI methods. ^{1 2 3 5 7}

Eligibility Criteria

This trial is for adult males with high-risk, localized prostate cancer who are planning to undergo radiation and hormone therapy. They must be in good health overall, have a specific level of disease severity (PSA ≥20 ng/mL or advanced stage), and agree to follow the study procedures. Men with other cancers, previous prostate treatments, or conditions that interfere with MRI scans cannot participate.

Inclusion Criteria

Provision of signed and dated informed consent form

Stated willingness to comply with all study procedures and availability for the duration of the study

My prostate cancer is high-risk with a PSA over 20, or it's in an advanced stage, or my Gleason score is 8 or higher.

Exclusion Criteria

I have another cancer, but it's either in remission or won't affect my prostate cancer treatment.

MRI or CT scan of the pelvis showing no clear evidence of bone or distant metastasis

I have had treatments like cryotherapy or surgery for prostate cancer.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Neoadjuvant Androgen Deprivation Therapy (ADT)

Participants receive neoadjuvant ADT and undergo RSI-MRI before and after this therapy

8-12 weeks

2 visits (in-person for MRI)

Radiotherapy (RT)

Participants undergo radiotherapy and an RSI-MRI is performed after completion

6-8 weeks

1 visit (in-person for MRI)

Follow-up

Participants are monitored for biochemical recurrence and PSA levels post-radiotherapy

3 years

Treatment Details

Interventions

• Restriction Spectrum Imaging Magnetic Resonance Imaging (MRI)

Trial Overview The ProsRSI trial is testing an advanced MRI technique called Restriction Spectrum Imaging (RSI-MRI) on patients undergoing standard treatment for high-risk prostate cancer. The goal is to see if RSI-MRI can predict how well the treatment works.

Participant Groups

Group I: RSI-MRI Experimental Treatment 1 Intervention

Participants will undergo RSI-MRI at three time points: before androgen deprivation therapy (ADT); after neoadjuvant ADT but before radiation therapy (RT); and after RT.

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

🇺🇸 Approved in United States as RSI-MRI for:

• Diagnostic imaging for prostate cancer
• Monitoring of prostate cancer treatment response

🇪🇺 Approved in European Union as RSI-MRI for:

• Diagnostic imaging for prostate cancer
• Monitoring of prostate cancer treatment response

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

UCSD Moores Cancer Center La Jolla, CA

Who Is Running the Clinical Trial?

University of California, San Diego Lead Sponsor

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Automated Patient-level Prostate Cancer Detection with Quantitative Diffusion Magnetic Resonance Imaging. [2023] Label="Background" NlmCategory="UNASSIGNED">Multiparametric magnetic resonance imaging (mpMRI) improves detection of clinically significant prostate cancer (csPCa), but the subjective Prostate Imaging Reporting and Data System (PI-RADS) system and quantitative apparent diffusion coefficient (ADC) are inconsistent. Restriction spectrum imaging (RSI) is an advanced diffusion-weighted MRI technique that yields a quantitative imaging biomarker for csPCa called the RSI restriction score (RSIrs).

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

Novel technique for characterizing prostate cancer utilizing MRI restriction spectrum imaging: proof of principle and initial clinical experience with extraprostatic extension. [2018] Standard magnetic resonance imaging (MRI) of the prostate lacks sensitivity in the diagnosis and staging of prostate cancer (PCa). To improve the operating characteristics of prostate MRI in the detection and characterization of PCa, we developed a novel, enhanced MRI diffusion technique using restriction spectrum imaging (RSI-MRI).

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

Restriction spectrum imaging improves MRI-based prostate cancer detection. [2018] To compare the diagnostic performance of restriction spectrum imaging (RSI), with that of conventional multi-parametric (MP) magnetic resonance imaging (MRI) for prostate cancer (PCa) detection in a blinded reader-based format.

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

Restriction Spectrum Imaging-Magnetic Resonance Imaging to Improve Prostate Cancer Imaging in Men on Active Surveillance. [2021] Restriction spectrum imaging-magnetic resonance imaging is a short duration enhanced diffusion-weighted technique that seeks to standardize sequences and predict upgrading. We test this technology for active surveillance biopsies. Our objective is to investigate the utility of restriction spectrum imaging-magnetic resonance imaging to improve upgrading detection in a prostate cancer active surveillance cohort.

5. England pubmed.ncbi.nlm.nih.gov

In vivo prostate cancer detection and grading using restriction spectrum imaging-MRI. [2022] Magnetic resonance imaging (MRI) is emerging as a robust, noninvasive method for detecting and characterizing prostate cancer (PCa), but limitations remain in its ability to distinguish cancerous from non-cancerous tissue. We evaluated the performance of a novel MRI technique, restriction spectrum imaging (RSI-MRI), to quantitatively detect and grade PCa compared with current standard-of-care MRI.

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

Utility of Restriction Spectrum Imaging Among Men Undergoing First-Time Biopsy for Suspected Prostate Cancer. [2020] OBJECTIVE. The purpose of this article is to evaluate restriction spectrum imaging (RSI) in men undergoing MRI-ultrasound fusion biopsy for suspected prostate cancer (PCa) and to compare the performance of RSI with that of conventional DWI. MATERIALS AND METHODS. One hundred ninety-eight biopsy-naïve men enrolled in a concurrent prospective clinical trial evaluating MRI-targeted prostate biopsy underwent multiparametric MRI with RSI. Clinical and imaging features were compared between men with and without clinically significant (CS) PCa (MRI-ultrasound fusion biopsy Gleason score ≥ 3 + 4). RSI z score and apparent diffusion coefficient (ADC) were correlated, and their diagnostic performances were compared. RESULTS. CS PCa was detected in 109 of 198 men (55%). Using predefined thresholds of ADC less than or equal to 1000 μm2/s and RSI z score greater than or equal to 3, sensitivity and specificity for CS PCa were 86% and 38%, respectively, for ADC and 61% and 70%, respectively, for RSI. In the transition zone (n = 69), the sensitivity and specificity were 94% and 17%, respectively, for ADC and 59% and 69%, respectively, for RSI. Among lesions with CS PCa, RSI z score and ADC were significantly inversely correlated in the peripheral zone (ρ = -0.4852; p < 0.01) but not the transition zone (ρ = -0.2412; p = 0.17). Overall diagnostic accuracies of RSI and DWI were 0.70 and 0.68, respectively (p = 0.74). CONCLUSION. RSI and DWI achieved equivalent diagnostic performance for PCa detection in a large population of men undergoing first-time prostate biopsy for suspected PCa, but RSI had superior specificity for transition zone lesions.

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

Restriction spectrum imaging: An evolving imaging biomarker in prostate MRI. [2022] Restriction spectrum imaging (RSI) is a novel diffusion-weighted MRI technique that uses the mathematically distinct behavior of water diffusion in separable microscopic tissue compartments to highlight key aspects of the tissue microarchitecture with high conspicuity. RSI can be acquired in less than 5 min on modern scanners using a surface coil. Multiple field gradients and high b-values in combination with postprocessing techniques allow the simultaneous resolution of length-scale and geometric information, as well as compartmental and nuclear volume fraction filtering. RSI also uses a distortion correction technique and can thus be fused to high resolution T2-weighted images for detailed localization, which improves delineation of disease extension into critical anatomic structures. In this review, we discuss the acquisition, postprocessing, and interpretation of RSI for prostate MRI. We also summarize existing data demonstrating the applicability of RSI for prostate cancer detection, in vivo characterization, localization, and targeting.