75 Participants Needed

MRI with Hyperpolarized Pyruvate for Advanced Prostate Cancer

MA
Overseen ByMaya Aslam
Age: 18+
Sex: Male
Trial Phase: Phase 2
Sponsor: Ivan de Kouchkovsky, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 1 JurisdictionThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

This is a prospective imaging study evaluating the utility of baseline metabolic MR imaging as a diagnostic and response monitoring tool in patients with advanced prostate cancer. Preliminary pre-clinical and clinical data demonstrates the ability of HP C-13 pyruvate/metabolic MR imaging to detect high-grade prostate cancer, including cancer with neuroendocrine differentiation, as well as provide early evidence of metabolic response and resistance following application of systemic therapies for the treatment of advanced prostate cancer patients. In the proposed study, the investigators aim is to extend the initial clinical results and further develop HP C-13 MRI as an imaging modality in advanced prostate cancer.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are on anti-coagulation medication and plan to undergo an optional tumor biopsy, you must be able to safely stop this treatment for the procedure.

What data supports the effectiveness of the treatment Hyperpolarized C13, Hyperpolarized 13C-Pyruvate, HP 13C Pyruvate, Hyperpolarized Carbon-13 Pyruvate for advanced prostate cancer?

Research shows that hyperpolarized 13C-pyruvate MRI can safely and effectively detect changes in tumor metabolism in prostate cancer, providing valuable information for diagnosis and treatment monitoring. This technique has demonstrated promising results in identifying cancer aggressiveness and early treatment response, making it a useful tool in managing prostate cancer.12345

Is MRI with Hyperpolarized Pyruvate safe for humans?

In a study involving 31 patients with prostate cancer, no serious side effects were observed when using hyperpolarized pyruvate for imaging, suggesting it is generally safe for human use.12367

How is the treatment using MRI with Hyperpolarized Pyruvate different from other prostate cancer treatments?

This treatment is unique because it uses hyperpolarized pyruvate in MRI to provide real-time images of cancer metabolism, allowing doctors to see how prostate cancer cells process energy differently. This approach offers a noninvasive way to detect and monitor cancer by tracking metabolic changes, which is not possible with standard imaging techniques.12378

Research Team

Id

Ivan de Kouchkovsky, MD

Principal Investigator

University of California, San Francisco

Eligibility Criteria

This trial is for men with advanced prostate cancer who can follow study procedures and have an ECOG status of 0 or 1, meaning they are fully active or restricted in physically strenuous activity but ambulatory. They must have a target lesion suitable for MRI imaging and no history of bleeding issues if undergoing biopsy. Men with certain metal implants, inability to consent, or contraindications to MRI cannot participate.

Inclusion Criteria

I have a detectable tumor suitable for a special MRI scan.
I don't have a bleeding disorder and can safely pause any blood-thinning medications for a biopsy.
My prostate cancer is advanced or has spread, confirmed by tests.
See 1 more

Exclusion Criteria

Any condition that, in the opinion of the Principal Investigator, would impair the patient's ability to comply with study procedures
Metallic hip implant or any other metallic implant or device that distorts local magnetic field and compromises the quality of MRI.
I am unable to give informed consent due to my age, health, or mental condition.
See 1 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Imaging

Participants undergo baseline metabolic MR imaging with hyperpolarized C-13 pyruvate to assess metabolic flux in target lesions

1 day
1 visit (in-person)

Treatment Monitoring

Participants in Cohort B undergo repeat metabolic MRI at baseline and 12 weeks to monitor response to systemic therapies

12 weeks
2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment completion

Up to 1 year

Treatment Details

Interventions

  • Hyperpolarized C13
Trial OverviewThe trial is testing the use of a special type of MRI that uses hyperpolarized carbon-13 (C-13) pyruvate as a diagnostic tool in advanced prostate cancer. It aims to see if this method can detect high-grade cancers and monitor how well systemic therapies are working by looking at changes in the metabolism within the tumor.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Cohort B: Hyperpolarized C13 MRI at multiple time pointsExperimental Treatment2 Interventions
Participants will undergo hyperpolarized (HP) C13 MRI at baseline and 12 weeks (+/- 8 weeks). Participants in Cohort B may undergo additional optional MR imaging at the time of disease progression. the same sequence of injections (C-1 labeled pyruvate first, C-2 labeled pyruvate second) will be used for subsequent scan time points as well.
Group II: Cohort A: Hyperpolarized C13 MRI at a single time pointExperimental Treatment2 Interventions
Participants will undergo MR imaging with hyperpolarized 13C pyruvate of a pre-selected target lesion at a single time point and will receive up to two 13C pyruvate (C-1 and C-2 labeled 13C pyruvate) investigational medicinal product (IMP) injections on the day of imaging (2nd injection is optional), as well as optional MR- or CT- guided tumor biopsies at baseline and at the time of disease progression following completion of HP C-13 MRI at the corresponding time point

Find a Clinic Near You

Who Is Running the Clinical Trial?

Ivan de Kouchkovsky, MD

Lead Sponsor

Trials
3
Recruited
190+

Rahul Aggarwal

Lead Sponsor

Trials
13
Recruited
550+

National Institute for Biomedical Imaging and Bioengineering (NIBIB)

Collaborator

Trials
102
Recruited
21,600+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Findings from Research

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

References

Hyperpolarized 13C-pyruvate MRI detects real-time metabolic flux in prostate cancer metastases to bone and liver: a clinical feasibility study. [2021]
Hyperpolarized 13C lactate, pyruvate, and alanine: noninvasive biomarkers for prostate cancer detection and grading. [2018]
Metabolic imaging of patients with prostate cancer using hyperpolarized [1-¹³C]pyruvate. [2021]
The use of hyperpolarised 13C-MRI in clinical body imaging to probe cancer metabolism. [2023]
Pyruvate-lactate exchange and glucose uptake in human prostate cancer cell models. A study in xenografts and suspensions by hyperpolarized [1-13 C]pyruvate MRS and [18 F]FDG-PET. [2021]
Hyperpolarized Carbon 13 MRI: Clinical Applications and Future Directions in Oncology. [2023]
Hyperpolarized Carbon-13 MRI in Breast Cancer. [2023]
Hyperpolarized 13C MRI: Path to Clinical Translation in Oncology. [2023]