RSI MRI Monitoring for Prostate Cancer

(ProsRSI Trial)

Overseen By Michelle Padilla

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: University of California, San Diego

Must be taking: Androgen deprivation

Disqualifiers: Prior radiotherapy, Hip prosthesis, others

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

Approved in 2 Jurisdictions 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 explores a new use of MRI scans, called RSI-MRI (Restriction Spectrum Imaging Magnetic Resonance Imaging), to determine if they can predict treatment effectiveness for men with high-risk prostate cancer. The study targets those planning to undergo radiation and hormone-blocking treatments. It suits men with doctor-confirmed prostate cancer who have not received prior treatments like surgery or other therapies. Participants will undergo RSI-MRI scans before, during, and after treatment to monitor changes. As a Phase 2 trial, the research focuses on assessing treatment effectiveness in an initial, smaller group of participants.

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 prior data suggests that RSI-MRI is safe for prostate cancer patients?

Research shows that Restriction Spectrum Imaging (RSI) MRI is a promising method for detecting aggressive prostate cancer. Studies have demonstrated its accuracy in identifying cancerous areas in the prostate, providing reassurance about its reliability and reducing the likelihood of missed diagnoses.

In past research, RSI-MRI has been used without significant negative effects, suggesting that patients generally tolerate the procedure well. Although the current trial is in an early stage, and complete safety information is still being collected, previous studies have not raised major safety concerns regarding RSI-MRI.

Based on its previous use and the lack of reported side effects, RSI-MRI appears to be a safe and effective tool for monitoring prostate cancer treatment. However, as with any medical procedure, discussing any concerns with a healthcare provider is important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about RSI MRI for prostate cancer because it offers a new way to monitor the disease more precisely than traditional imaging methods. Most imaging techniques for prostate cancer rely on detecting changes in tumor size, but RSI MRI focuses on the tumor's cellular structure, giving a clearer picture of how the cancer is responding to treatment. This approach could lead to more personalized treatment plans, as doctors can adjust therapies based on how the cancer behaves at a cellular level. By potentially identifying changes earlier, RSI MRI might help in making quicker and more informed treatment decisions.

What evidence suggests that RSI-MRI is effective for monitoring prostate cancer?

Research has shown that Restriction Spectrum Imaging (RSI-MRI), which participants in this trial will undergo, excels at detecting aggressive prostate cancer. Studies have found that RSI-MRI can better track the progression of prostate cancer compared to standard imaging methods. It is both highly sensitive and specific, accurately identifying cases of prostate cancer. Additionally, RSI-MRI achieves this without the need for contrast dye, often used in other MRI types. This suggests that RSI-MRI could be a promising tool for predicting how prostate cancer will respond to treatments like radiation therapy. ^{1 2 3 4 6}

Who Is on the Research Team?

Tyler Seibert, MD, PhD

Principal Investigator

University of California, San Diego

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Restriction Spectrum Imaging Magnetic Resonance Imaging

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.

How Is the Trial Designed?

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

Who Is Running the Clinical Trial?

University of California, San Diego

Lead Sponsor

Trials

1,215

Recruited

1,593,000+

Published Research Related to This Trial

The novel restriction spectrum imaging (RSI-MRI) technique significantly outperformed standard MRI in detecting extraprostatic extension (EPE) in prostate cancer patients, identifying EPE in 89% of cases compared to only 22% with standard MRI.

This study involved 28 prostate cancer patients, and the results suggest that RSI-MRI could greatly enhance the accuracy of prostate cancer imaging, warranting further research for its clinical application.

NCBI (Pubmed)

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. Rakow-Penner, RA., White, NS., Parsons, JK., et al.[2018]

The study evaluated 100 patients, including 67 with confirmed prostate cancer, and found that combining restriction spectrum imaging (RSI) with multi-parametric MRI (MP-MRI) significantly improved the detection of high-grade prostate cancer, achieving higher diagnostic accuracy (AUC of 0.78 vs. 0.70 for sextant level).

RSI used alongside T2-weighted imaging (T2WI) provided similar detection rates for high-grade prostate cancer as MP-MRI alone, indicating that RSI can be a valuable tool in prostate cancer diagnostics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Restriction spectrum imaging improves MRI-based prostate cancer detection. McCammack, KC., Schenker-Ahmed, NM., White, NS., et al.[2018]

Restriction spectrum imaging-magnetic resonance imaging (RSI-MRI) significantly improves the detection of upgrading in prostate cancer during active surveillance, showing a higher accuracy compared to traditional methods, with an area under the curve (AUC) increasing from 0.70 to 0.90.

In a study of 123 men undergoing repeat biopsy, RSI-MRI provided better sensitivity and specificity for identifying true-positive lesions, indicating its potential as a valuable noninvasive tool for monitoring prostate cancer progression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Restriction Spectrum Imaging-Magnetic Resonance Imaging to Improve Prostate Cancer Imaging in Men on Active Surveillance. Besasie, BD., Sunnapwar, AG., Gao, F., et al.[2021]

Restriction spectrum imaging (RSI) provides a quantitative biomarker, the RSI restriction score (RSIrs), which significantly improves the detection of clinically significant prostate cancer (csPCa) compared to traditional methods like the apparent diffusion coefficient (ADC). In a study of 151 patients, RSIrs achieved an area under the curve (AUC) of 0.78, indicating strong performance in identifying csPCa.

The combination of RSIrs and the Prostate Imaging Reporting and Data System (PI-RADS) scores resulted in an even higher AUC of 0.85, suggesting that using both methods together is more effective than using either one alone for detecting csPCa.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Automated Patient-level Prostate Cancer Detection with Quantitative Diffusion Magnetic Resonance Imaging. Zhong, AY., Digma, LA., Hussain, T., et al.[2023]

In a study of 33 patients with prostate cancer, the novel restriction spectrum imaging (RSI-MRI) technique showed a superior ability to differentiate cancerous tissue from normal tissue compared to standard diffusion MRI, achieving an area under the ROC curve (AUC) of 0.94 versus 0.85.

RSI-MRI also outperformed conventional MRI in predicting the aggressiveness of prostate cancer, with a significant correlation to tumor grade, indicating its potential to enhance diagnosis and characterization of the disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In vivo prostate cancer detection and grading using restriction spectrum imaging-MRI. McCammack, KC., Kane, CJ., Parsons, JK., et al.[2022]

Restriction spectrum imaging (RSI) is a new MRI technique that can quickly provide detailed information about tissue microarchitecture in less than 5 minutes, making it a promising tool for prostate cancer detection and characterization.

RSI enhances the ability to localize disease by combining water diffusion data with high-resolution T2-weighted images, improving the delineation of cancer spread into important anatomical areas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Restriction spectrum imaging: An evolving imaging biomarker in prostate MRI. Brunsing, RL., Schenker-Ahmed, NM., White, NS., et al.[2022]

In a study of 198 biopsy-naïve men, restriction spectrum imaging (RSI) demonstrated comparable diagnostic performance to conventional diffusion-weighted imaging (DWI) for detecting clinically significant prostate cancer, with overall accuracies of 0.70 for RSI and 0.68 for DWI.

RSI showed better specificity for detecting prostate cancer in the transition zone compared to DWI, indicating that RSI may be particularly useful for identifying lesions in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Utility of Restriction Spectrum Imaging Among Men Undergoing First-Time Biopsy for Suspected Prostate Cancer. Felker, ER., Raman, SS., Shakeri, S., et al.[2020]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5386962/

Restriction spectrum imaging improves MRI-based prostate ... Including RSI with MP-MRI improves PCa detection compared to MP-MRI alone, and RSI with T2WI achieves similar PCa detection as MP-MRI. Keywords: Prostate MRI, ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2666168324014344

Trial Protocol Advanced Restriction Imaging and ... ART-Pro is a multisite, multinational trial that aims to evaluate whether IV contrast can be avoided in the setting of standardized, state-of-the-art image ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04992728

Prostate Assessment with Restriction Spectrum Imaging ... Several advanced MRI models will be applied to the data, and the models will be assessed for accurate prediction of grade group ≥2 prostate cancer on ...

4. auajournals.org auajournals.org/doi/10.1097/JU.0000000000001692

Restriction Spectrum Imaging-Magnetic Resonance ... Restriction spectrum imaging is highly sensitive and specific for detecting early stage, aggressive prostate cancer. The PI-RADS® scoring system ...

5. news.uthscsa.edu news.uthscsa.edu/ut-health-san-antonio-study-shows-mri-technique-improves-detection-of-aggressive-prostate-cancer/

UT Health San Antonio study shows MRI technique ... An MRI scan called restriction spectrum imaging greatly improves the detection of prostate cancer progression, according to a published study.

6. auajournals.org auajournals.org/doi/pdf/10.1097/JU.0000000000001692

Restriction Spectrum Imaging-Magnetic Resonance ... Restriction spectrum imaging is highly sensitive and specific for detecting early stage, aggressive prostate cancer.9 The PI-RADS® scoring system is heavily ...