RSI MRI Monitoring for Prostate Cancer

(ProsRSI Trial)

Overseen By Michelle Padilla

Age: 18+

Sex: Male

Trial Phase: Phase 2

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)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

100 Participants Needed

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}

Research Team

Tyler Seibert, MD, PhD

Principal Investigator

University of California, San Diego

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.

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

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

Who Is Running the Clinical Trial?

University of California, San Diego

Lead Sponsor

Trials

1,215

Recruited

1,593,000+

Findings from Research

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]

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]

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]

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]

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]

References

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

Automated Patient-level Prostate Cancer Detection with Quantitative Diffusion Magnetic Resonance Imaging. [2023]

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]

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

Restriction spectrum imaging improves MRI-based prostate cancer detection. [2018]

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]

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

In vivo prostate cancer detection and grading using restriction spectrum imaging-MRI. [2022]

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

Utility of Restriction Spectrum Imaging Among Men Undergoing First-Time Biopsy for Suspected Prostate Cancer. [2020]

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

Restriction spectrum imaging: An evolving imaging biomarker in prostate MRI. [2022]