Hyperpolarized MRI for Prostate Cancer

Overseen By Minhaj Siddiqui, MD

Age: 18+

Sex: Male

Trial Phase: Phase 2

Sponsor: University of Maryland, Baltimore

Disqualifiers: Inability to undergo MRI, 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: 1

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to image prostate cancer using a special type of MRI that examines metabolism, or how cells process energy. The goal is to determine if this imaging technique is safe for men suspected or known to have prostate cancer. The study uses a substance called hyperpolarized 13C-Pyruvate to enhance MRI images. Men with a clinical suspicion or history of prostate cancer, indicated by certain tests or symptoms, and who are planning further procedures like a biopsy or surgery, might be suitable candidates for this trial. As a Phase 2 trial, this research focuses on assessing the effectiveness of the imaging technique in an initial, smaller group, offering participants a chance to contribute to advancements in prostate cancer diagnostics.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this metabolic MRI technique is safe for men suspected to have prostate cancer?

Research has shown that hyperpolarized 13C-pyruvate MRI has been safely tested in humans. Studies indicate that this technique can examine changes in energy processing without causing significant side effects.

In a previous study, researchers tested this MRI type and found it safe for patients. It was used to observe metabolism in prostate cancer and did not cause any serious health issues, suggesting it is well-tolerated.

Overall, evidence shows that hyperpolarized 13C-pyruvate MRI is safe for people, particularly for monitoring prostate cancer. Participants in the trials did not report any major safety concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about hyperpolarized 13C-pyruvate because it offers a novel way to visualize prostate cancer. Unlike standard imaging techniques, which rely primarily on anatomical differences, this method uses metabolic magnetic resonance imaging (MRI) to detect changes in the metabolism of cancer cells. This hyperpolarized MRI technique can potentially identify cancerous tissues with greater precision and safety. By highlighting metabolic activity, it may help differentiate aggressive tumors from less harmful ones, offering a more tailored approach to diagnosis and treatment planning.

What evidence suggests that hyperpolarized 13C-Pyruvate MRI is effective for prostate cancer?

Studies have shown that hyperpolarized 13C-pyruvate MRI can detect important changes in prostate tumors that other methods might miss. Research suggests this technique accurately identifies prostate cancer by revealing how cancer cells use energy differently. In previous studies, this MRI method observed real-time changes in the metabolism of metastatic cancer. More than 100 patients have been studied using this approach, consistently demonstrating its effectiveness in identifying and analyzing prostate cancer. This trial will employ hyperpolarized 13C-pyruvate MRI to potentially offer a new way to understand prostate cancer, aiding in diagnosis and treatment planning. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for men aged 40-80 who may have prostate cancer, indicated by a PSA level over 4ng/ml, an abnormal DRE exam, or a known diagnosis from previous tests. Participants should be planning to undergo a biopsy or surgery for prostate cancer.

Inclusion Criteria

I have signs of prostate cancer, such as a high PSA level, an abnormal exam, or a known diagnosis.

I am between 41 and 79 years old.

Exclusion Criteria

I cannot have IV contrast due to hospital rules.

You cannot have an MRI scan.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging

Perform metabolic magnetic resonance imaging on men suspected to have prostate cancer

1-2 weeks

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after imaging

Within three years post treatment

What Are the Treatments Tested in This Trial?

Interventions

• Hyperpolarized 13C-Pyruvate

Trial Overview The study is testing the use of metabolic MRI using Hyperpolarized 13C-Pyruvate on men suspected of having prostate cancer. It aims to determine if this type of advanced imaging can be done safely in these patients.

How Is the Trial Designed?

Group I: Single-arm study in patients who are suspected or known to have prostate cancer Experimental Treatment 1 Intervention

Perform metabolic magnetic resonance imaging on men suspected to have a prostate cancer to understand if metabolic MRI can be safely performed on this population

Hyperpolarized 13C-Pyruvate is already approved in United States, European Union for the following indications:

Approved in United States as Hyperpolarized 13C Pyruvate MRI for:

• Prostate cancer
• Research use in various cancers

Approved in European Union as Hyperpolarized 13C Pyruvate MRI for:

• Research use in various cancers

Who Is Running the Clinical Trial?

University of Maryland, Baltimore

Lead Sponsor

Trials

729

Recruited

540,000+

Published Research Related to This Trial

This study demonstrates that hyperpolarized (HP) (13)C MR spectroscopy can effectively track metabolic changes in prostate cancer, showing increased pyruvate to lactate flux in malignant tissue compared to benign tissue, which correlates with specific metabolic markers.

The research provides the first mechanistic evidence that HP (13)C lactate can serve as a biomarker for prostate cancer in living human tissues, paving the way for better identification of cancer presence and aggressiveness in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Metabolic reprogramming and validation of hyperpolarized 13C lactate as a prostate cancer biomarker using a human prostate tissue slice culture bioreactor. Keshari, KR., Sriram, R., Van Criekinge, M., et al.[2021]

Hyperpolarized magnetic resonance imaging (MRI) of pyruvate metabolism shows consistent delivery and conversion in patients with primary prostate cancer, indicating its potential reliability for metabolic imaging.

The study found that higher lactate levels correlate with more aggressive cancer (higher Gleason grade) and are associated with specific genomic alterations, such as PTEN loss, suggesting a link between cancer genetics and metabolic changes that could inform treatment strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hyperpolarized MRI of Human Prostate Cancer Reveals Increased Lactate with Tumor Grade Driven by Monocarboxylate Transporter 1. Granlund, KL., Tee, SS., Vargas, HA., et al.[2021]

The study demonstrated that hyperpolarized [1-¹³C]pyruvate is safe for use in humans, with no dose-limiting toxicities observed in 31 prostate cancer patients, confirming its potential for noninvasive imaging.

The imaging technique successfully detected elevated levels of [1-¹³C]lactate in tumor regions, indicating its effectiveness in characterizing tumor metabolism and potentially aiding in cancer diagnosis and treatment monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Metabolic imaging of patients with prostate cancer using hyperpolarized [1-¹³C]pyruvate. Nelson, SJ., Kurhanewicz, J., Vigneron, DB., et al.[2021]

This study demonstrates that hyperpolarized (13)C-labeled pyruvate can effectively differentiate between various histologic grades of prostate cancer in a mouse model, with significant increases in hyperpolarized lactate levels correlating with cancer progression.

Elevated levels of hyperpolarized lactate, along with total hyperpolarized carbon (THC) and alanine, serve as promising noninvasive biomarkers for detecting prostate cancer and assessing its severity, potentially enhancing future imaging techniques in patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hyperpolarized 13C lactate, pyruvate, and alanine: noninvasive biomarkers for prostate cancer detection and grading. Albers, MJ., Bok, R., Chen, AP., et al.[2018]

Hyperpolarized 13C MRI has shown promise in providing unique metabolic insights into cancer, with a dose-ranging study confirming its safety and feasibility in patients with prostate cancer.

Ongoing research is exploring the use of hyperpolarized agents in various cancer types, and advancements in technology and collaboration among academia, industry, and government are essential for translating this imaging technique into clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hyperpolarized 13C MRI: Path to Clinical Translation in Oncology. Kurhanewicz, J., Vigneron, DB., Ardenkjaer-Larsen, JH., et al.[2023]

Carbon-13 magnetic resonance imaging (MRI) using hyperpolarised [1-13C]pyruvate is a promising new method for detecting altered metabolism in tumors, showing safety and feasibility in early human studies involving patients with various cancers, including prostate and breast cancer.

This technique allows for dynamic, noninvasive imaging of metabolic changes, potentially identifying treatment responses earlier than traditional multiparametric MRI, and offers unique insights into tumor aggressiveness and heterogeneity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of hyperpolarised 13C-MRI in clinical body imaging to probe cancer metabolism. Woitek, R., Gallagher, FA.[2023]

Hyperpolarized carbon 13 MRI (13C MRI) is a groundbreaking imaging technique that allows for real-time, noninvasive observation of tissue metabolism, particularly useful in cancer research.

This method has shown promise in clinical applications such as tumor grading, tailoring treatment based on metabolic profiles, and detecting early treatment responses by monitoring metabolic changes before structural alterations in tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hyperpolarized Carbon 13 MRI: Clinical Applications and Future Directions in Oncology. Deen, SS., Rooney, C., Shinozaki, A., et al.[2023]

Hyperpolarized 13C-pyruvate MRI successfully detected high rates of glycolytic metabolism in metastatic prostate cancer, with specific kPL values indicating metabolic activity in bone and liver metastases.

The study demonstrated that HP 13C-pyruvate MRI can measure changes in metabolism over time, showing a decrease in kPL values in response to chemotherapy, suggesting its potential as a tool for monitoring treatment efficacy in advanced prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hyperpolarized 13C-pyruvate MRI detects real-time metabolic flux in prostate cancer metastases to bone and liver: a clinical feasibility study. Chen, HY., Aggarwal, R., Bok, RA., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7984723/

Hyperpolarized [1-13C]-Pyruvate Magnetic Resonance ... In this study, we demonstrate that hyperpolarized 13C-pyruvate MRSI detects metabolic differences in prostate tumor xenografts that are not detectable by steady ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04698564

Utility of Hyperpolarized 13C-pyruvate Metabolic Magnetic ... To study the accuracy of hyperpolarized metabolic MRI to diagnose prostate cancer. Compare the prediction of cancer from the MRI scan compared to actual ...

3. mdpi.com mdpi.com/2072-6694/17/13/2211

Multivariate Framework of Metabolism in Advanced ... A novel hyperpolarized (HP) 13 C MRI-specific multivariate framework was developed and evaluated in 16 patients with advanced or metastatic prostate cancer.

4. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1002/mrm.30570

Consensus recommendations for hyperpolarized [1- 13 C] ... In 2013, the first human study with HP [1-13C]pyruvate was reported in patients with prostate cancer. Since then, there have been over 100 ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/31685983/

Hyperpolarized 13 C-pyruvate MRI detects real-time metabolic ... HP 13 C-pyruvate MRI can detect real-time glycolytic metabolism within prostate cancer metastases, and can measure changes in quantitative k PL values ...

6. nature.com nature.com/articles/s41391-019-0180-z

Hyperpolarized 13 C-pyruvate MRI detects real-time ... HP 13 C-pyruvate MRI can detect real-time glycolytic metabolism within prostate cancer metastases, and can measure changes in quantitative k PL values ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4201045/

Metabolic Imaging of Patients with Prostate Cancer Using ... This first-in-man imaging study evaluated the safety and feasibility of hyperpolarized [1-13C]pyruvate as an agent for noninvasively characterizing alterations ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT03933670

Hyperpolarized Pyruvate (13C) MR Imaging in Monitoring ... This phase II trial studies the side how well hyperpolarized carbon C 13 pyruvate (HP C-13 pyruvate) magnetic resonance imaging (MRI) works in monitoring ...

9. sciencedirect.com sciencedirect.com/science/article/pii/S2666441024000207

Dual hyperpolarized [1-13C]pyruvate and [13C]urea ... Hyperpolarized [1-13C]pyruvate MRI was able to detect areas of clinically occult prostate cancer not seen on multiparametric MRI. •. The novel addition of ...

10. dctd.cancer.gov dctd.cancer.gov/drug-discovery-development/reagents-materials/imaging-ind-resources/documentation/13c-pyruvate-clinical.pdf

Summary of Data: Clinical prostate cancer access the safety and tolerability and imaging potential of hyperpolarized [1-13C] pyruvate Injection via 13C imaging (13C MRI) and 13C MR ...