MRI Monitoring for Prostate Cancer

Overseen By Louise Magat

Age: 18+

Sex: Male

Trial Phase: Phase 2

Sponsor: University of California, San Francisco

Must not be taking: Androgen deprivation therapy

Disqualifiers: No prostate cancer, Radiation, Hypertension, Heart failure, 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 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

60 Participants Needed

Trial Summary

What is the purpose of this trial?

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 patients with prostate cancer on active surveillance who have not received treatment. Diagnostic procedures, such as MRI, may help visualize HP C-13 pyruvate uptake and breakdown in tumor cells.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but it does require that you have not had certain prostate cancer treatments recently. If you are on a 5-alpha reductase inhibitor, it must be stopped at least 28 days before the MRI.

What data supports the effectiveness of the treatment Hyperpolarized Carbon C 13 Pyruvate for prostate cancer?

Research shows that Hyperpolarized Carbon C 13 Pyruvate MRI can detect changes in tumor metabolism, which helps in diagnosing and monitoring prostate cancer. Studies have demonstrated its ability to provide real-time imaging of cancer metabolism, showing increased levels of certain metabolic products in high-grade tumors, which can be useful for assessing treatment response. ^{1 2 3 4 5}

Is Hyperpolarized Carbon C 13 Pyruvate safe for use in humans?

Studies have shown that Hyperpolarized Carbon C 13 Pyruvate is safe for use in humans, with no dose-limiting toxicities observed in clinical trials involving prostate cancer patients. ^{1 3 4 5 6}

How does MRI monitoring for prostate cancer differ from other treatments?

MRI monitoring using hyperpolarized 13C-pyruvate is unique because it allows real-time imaging of prostate cancer metabolism, providing a noninvasive way to assess tumor activity and response to treatment. This method enhances the MRI signal significantly, making it possible to track metabolic changes in the cancer cells, which is not possible with standard imaging techniques. ^{1 3 4 5 7}

Research Team

Ivan de Kouchkovsky, MD

Principal Investigator

University of California, San Francisco

Eligibility Criteria

This trial is for men with low to intermediate risk prostate cancer who are on active surveillance and haven't had treatment. They must be able to follow the study plan, have a good performance status (able to carry out daily activities), adequate blood counts, and normal liver function. Men can't join if they've had recent prostate treatments or biopsies, uncontrolled high blood pressure, heart failure, no evidence of cancer in their last biopsy, hormone therapy for cancer, or can't undergo MRI due to medical devices or severe claustrophobia.

Inclusion Criteria

I am fully active or restricted in physically strenuous activity but can do light work.

Platelets >= 75,000 cells/uL

The subject is able and willing to comply with study procedures and provide signed and dated informed consent

Exclusion Criteria

My blood pressure is not higher than 160/100 mm Hg, or it's controlled with medication.

Contraindication to or inability to tolerate MRI with endorectal coil (e.g. severe claustrophobia, presence of cardiac pacemaker, aneurysm clip, severe or painful hemorrhoids, rectal stricture)

I had a prostate biopsy within the last 14 days.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Imaging and Biopsy

Participants receive hyperpolarized carbon C 13 pyruvate intravenously and undergo magnetic resonance spectroscopic imaging (MRSI), followed by MR/US fusion-guided prostate biopsy

Up to 12 weeks

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after baseline imaging and biopsy

Up to 15 months

Optional Follow-up Imaging

Participants may undergo optional follow-up HP C-13 pyruvate/MRI 6-15 months following baseline scan to assess changes in intra-tumoral kPL and kPG

6-15 months

Treatment Details

Interventions

• Hyperpolarized Carbon C 13 Pyruvate

Trial Overview The trial is testing how well a special type of MRI scan using hyperpolarized carbon C 13 pyruvate can monitor prostate cancer progression in patients under active surveillance. The imaging aims to observe the uptake and breakdown of this substance in tumor cells without having treated the cancer yet.

Participant Groups

Group I: Diagnostic (HP C-13 MRI) Experimental Treatment 3 Interventions

Patients receive hyperpolarized carbon C 13 pyruvate IV over less than one minute, then undergo MRSI after 1-2 minutes. Within 15-60 minutes, patients may receive optional hyperpolarized carbon C 13 pyruvate and undergo MRSI. Patients also undergo MR/US fusion-guided prostate biopsy within 12 weeks following HP C-13 MRSI.

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

National Institute for Biomedical Imaging and Bioengineering (NIBIB)

Collaborator

Trials

102

Recruited

21,600+

Findings from Research

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 [1-13C]-pyruvate magnetic resonance spectroscopic imaging (MRSI) can effectively predict the efficacy of targeting the Warburg effect in prostate cancer, as demonstrated by enhanced lactate production in DU145 tumors compared to PC3 tumors.

The study found that DU145 tumors were more sensitive to lactate dehydrogenase (LDH) inhibition, indicating that MRSI could serve as a valuable biomarker for assessing treatment responses in prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hyperpolarized [1-13C]-Pyruvate Magnetic Resonance Spectroscopic Imaging of Prostate Cancer In Vivo Predicts Efficacy of Targeting the Warburg Effect. Scroggins, BT., Matsuo, M., White, AO., 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]

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, which enhances the detection of tumor metabolism by 4-5 orders of magnitude, can track the metabolism of hyperpolarized [1-13C]pyruvate in cancer patients, providing insights into tumor activity and response to treatment.

Combining HP 13C-MRI with traditional 1H-MRI allows for detailed anatomical imaging and functional tumor analysis, potentially enabling early identification of patients who are not responding to therapies, although cost and technical challenges need to be addressed for broader clinical use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hyperpolarized Carbon-13 MRI in Breast Cancer. Woitek, R., Brindle, KM.[2023]

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 found that aggressive prostate cancer cells (PC3) showed significantly higher uptake of [18F]FDG compared to less aggressive cells (LNCaP), indicating that PET imaging can effectively differentiate between cancer aggressiveness.

Despite similar rates of pyruvate to lactate conversion in both cell types, a negative correlation was observed between [18F]FDG uptake and the rate of this conversion, suggesting that metabolic pathways in prostate cancer may differ from other tumors and highlighting the potential of combining imaging techniques for better diagnosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. van Heijster, FHA., Heskamp, S., Breukels, V., et al.[2021]

References

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

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

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

Hyperpolarized [1-13C]-Pyruvate Magnetic Resonance Spectroscopic Imaging of Prostate Cancer In Vivo Predicts Efficacy of Targeting the Warburg Effect. [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. United States pubmed.ncbi.nlm.nih.gov

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

5. Switzerland pubmed.ncbi.nlm.nih.gov

Hyperpolarized Carbon-13 MRI in Breast Cancer. [2023]

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

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

7. England pubmed.ncbi.nlm.nih.gov

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]