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MRI with Hyperpolarized Pyruvate for Advanced Prostate Cancer

Phase 2

Recruiting

Led By Rahul Aggarwahl, MD

Research Sponsored by Ivan de Kouchkovsky, MD

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Able and willing to comply with study procedures and provide signed and dated informed consent. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1

Be older than 18 years old

Must not have

Patients who because of age, general medical or psychiatric condition, or physiologic status cannot give valid informed consent.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 year

Awards & highlights

No Placebo-Only Group

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.

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.

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 can follow the study's procedures and have signed the consent. I am mostly active.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am unable to give informed consent due to my age, health, or mental condition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 year

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

Intra-tumoral range of kPG measurement within target lesion

Intra-tumoral range of kPL measurement within target lesion

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 2Eligibility criteria met