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

Trial Summary

What is the purpose of this trial?

This is a two-tiered pilot study in which there will be no randomization and no placebo treatment. This study will be to 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

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 data supports the effectiveness of the treatment Hyperpolarized 13C-Pyruvate MRI for prostate cancer?

Research shows that Hyperpolarized 13C-Pyruvate MRI can safely and effectively detect changes in tumor metabolism in prostate cancer, providing real-time information that helps in diagnosing and monitoring the disease. This technique has shown promise in identifying cancerous areas and assessing treatment responses earlier than traditional imaging methods. ^{1 2 3 4 5}

Is Hyperpolarized 13C-Pyruvate MRI safe for humans?

Studies have shown that Hyperpolarized 13C-Pyruvate MRI is safe for humans, with no dose-limiting toxicities observed in clinical trials involving prostate cancer patients. ^{1 2 3 6 7}

What makes Hyperpolarized 13C-Pyruvate MRI unique for prostate cancer treatment?

Hyperpolarized 13C-Pyruvate MRI is unique because it allows doctors to see real-time changes in the metabolism of prostate cancer cells, providing a clearer picture of how aggressive the cancer is and how it responds to treatment. This imaging technique enhances the MRI signal significantly, making it possible to detect metabolic changes that are not visible with standard imaging methods. ^{1 2 3 5 8}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

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]

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]

References

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

Hyperpolarized 13C lactate, pyruvate, and alanine: noninvasive biomarkers for prostate cancer detection and grading. [2018]

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

Metabolic imaging of patients with prostate cancer using hyperpolarized [1-¹³C]pyruvate. [2021]

3. England 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. [2021]

4. England pubmed.ncbi.nlm.nih.gov

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

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

Hyperpolarized Carbon 13 MRI: Clinical Applications and Future Directions in Oncology. [2023]

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

Hyperpolarized MRI of Human Prostate Cancer Reveals Increased Lactate with Tumor Grade Driven by Monocarboxylate Transporter 1. [2021]

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

Hyperpolarized 13C MRI: Path to Clinical Translation in Oncology. [2023]

8. United States 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. [2021]