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MRI with Hyperpolarized Pyruvate for Advanced Prostate Cancer

Phase 2
Recruiting
Led By Rahul Aggarwahl, MD
Research Sponsored by Rahul Aggarwal
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Presence of at least one target lesion detected by standard staging scans that, in the judgment of Study Investigators, would be amenable to hyperpolarized C-13 pyruvate/metabolic MR imaging: Soft tissue/visceral organ target lesions must measure at 1 cm in long axis diameter on CT or MRI. Target lesions in the bone must be visualized by CT or MRI (lesions present only on bone scan do not qualify). For patients with target lesion in prostate/prostatic bed: i. No contra-indications to endorectal coil insertion (e.g., patients with a prior abdominoperineal resection of the rectum or latex allergy). ii. No prior local treatment to the selected lesion, or evidence of radiographic progression following prior local therapy to selected lesion.
For patients undergoing optional tumor biopsy: No history of bleeding diathesis. Patients on anti-coagulation they must be able to safely stop treatment for purposes of tumor biopsy.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights

Study Summary

This trial is testing whether a specific kind of MR imaging can help detect and track prostate cancer that has spread, including a type that is hard to treat.

Who is the study for?
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.Check my eligibility
What is being tested?
The 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.See study design
What are the potential side effects?
Since this trial focuses on diagnostic imaging rather than treatment, side effects may include discomfort from lying still during the MRI procedure, potential risks associated with endorectal coil insertion for those needing it, and standard risks related to biopsies such as pain or bleeding.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have a detectable tumor suitable for a special MRI scan.
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I don't have a bleeding disorder and can safely pause any blood-thinning medications for a biopsy.
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My prostate cancer is advanced or has spread, confirmed by tests.
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I can follow the study's procedures and have signed the consent. I am mostly active.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Mean percent change from baseline in intra-tumoral kPG within target lesion after treatment.
Mean percent change from baseline in intra-tumoral kPL within target lesion after treatment. (Cohort B)
Pyruvate to glutamate (kPG) metabolic flux within target lesion (Cohort A).
+1 more
Secondary outcome measures
Intra-tumoral range of kPG measurement within target lesion
Intra-tumoral range of kPL measurement within target lesion

Trial Design

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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Magnetic Resonance Imaging (MRI)
2015
Completed Phase 4
~1800

Find a Location

Who is running the clinical trial?

Rahul AggarwalLead Sponsor
11 Previous Clinical Trials
445 Total Patients Enrolled
6 Trials studying Prostate Cancer
203 Patients Enrolled for Prostate Cancer
National Cancer Institute (NCI)NIH
13,627 Previous Clinical Trials
40,927,320 Total Patients Enrolled
560 Trials studying Prostate Cancer
507,096 Patients Enrolled for Prostate Cancer
Rahul Aggarwahl, MDPrincipal InvestigatorUniversity of California, San Francisco

Media Library

Hyperpolarized C13 Clinical Trial Eligibility Overview. Trial Name: NCT04346225 — Phase 2
Prostate Cancer Research Study Groups: Cohort A: Hyperpolarized C13 MRI at a single time point, Cohort B: Hyperpolarized C13 MRI at multiple time points
Prostate Cancer Clinical Trial 2023: Hyperpolarized C13 Highlights & Side Effects. Trial Name: NCT04346225 — Phase 2
Hyperpolarized C13 2023 Treatment Timeline for Medical Study. Trial Name: NCT04346225 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants is this clinical trial accommodating?

"Affirmative. According to clinicaltrials.gov, this medical study is welcoming applicants as it was first published on July 16th 2020 and last updated on July 27th 2022. It aims to enrol 75 patients at one location."

Answered by AI

Are there any openings left for participants in this investigation?

"As per clinicaltrials.gov this investigation is open for recruitment, having been initiated on July 16th 2020 and last revised on July 27th 2022."

Answered by AI

Could you provide information on the safety of Hyperpolarized C13 for individuals being treated?

"Hyperpolarized C13 was deemed to have a score of 2 based on the evidence available. This is because, while there are some indications that it may be safe, no studies suggest its efficacy yet."

Answered by AI
~24 spots leftby Dec 2025