← Back to Search

MRI Monitoring for Prostate Cancer

Phase 2
Recruiting
Led By Ivan de Kouchkovsky, MD
Research Sponsored by University of California, San Francisco
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 15 months
Awards & highlights

Study Summary

This trial looks at using MRI to see how well a cancer treatment is working for patients with prostate cancer who are being actively monitored but have not yet received treatment.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Since this trial involves diagnostic procedures like advanced MRI scans rather than drugs or invasive treatments, side effects may include discomfort from lying still during the scan or reactions related to contrast agents used if any (e.g., allergic reactions). There's also a small risk associated with endorectal coils used during MRI.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
My prostate cancer is confirmed and considered low to intermediate risk.
Select...
I am either planning to or currently under active surveillance for my condition.
Select...
My kidneys work well enough, with a creatinine clearance of 50 mL/min or more.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 15 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 15 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Association between intra-tumoral C-pyruvate to glutamate (kPG) with Gleason grade
Association between intra-tumoral C-pyruvate to lactate (kPL) with Gleason grade
Intra-tumoral C-pyruvate to glutamate (kPG)
+2 more
Secondary outcome measures
Association between peak intra-tumoral kPL observed on baseline imaging with serum PSA
Neoplasms
Contrast between kPL and kPG in regions of tumor
+4 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Diagnostic (HP C-13 MRI)Experimental Treatment3 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Magnetic Resonance Spectroscopic Imaging
2012
Completed Phase 1
~430
Hyperpolarized Carbon C 13 Pyruvate
2018
Completed Phase 1
~10

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,627 Previous Clinical Trials
40,927,775 Total Patients Enrolled
560 Trials studying Prostate Cancer
507,111 Patients Enrolled for Prostate Cancer
University of California, San FranciscoLead Sponsor
2,496 Previous Clinical Trials
11,933,429 Total Patients Enrolled
51 Trials studying Prostate Cancer
16,973 Patients Enrolled for Prostate Cancer
National Institute for Biomedical Imaging and Bioengineering (NIBIB)NIH
88 Previous Clinical Trials
19,664 Total Patients Enrolled
4 Trials studying Prostate Cancer
115 Patients Enrolled for Prostate Cancer

Media Library

MRI Ultrasound Fusion Guided Biopsy Clinical Trial Eligibility Overview. Trial Name: NCT03933670 — Phase 2
Prostate Cancer Research Study Groups: Diagnostic (HP C-13 MRI)
Prostate Cancer Clinical Trial 2023: MRI Ultrasound Fusion Guided Biopsy Highlights & Side Effects. Trial Name: NCT03933670 — Phase 2
MRI Ultrasound Fusion Guided Biopsy 2023 Treatment Timeline for Medical Study. Trial Name: NCT03933670 — Phase 2

Frequently Asked Questions

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

Are there any available openings for patients who want to participate in this clinical trial?

"That is correct, the trial is still enrolling patients. According to the information on clinicaltrials.gov, this study was first posted on July 18th, 2018 and updated most recently on October 3rd, 2020. They are looking for a total of 60 participants at 1 location."

Answered by AI

Does the FDA condone the therapeutic use of Hyperpolarized Carbon C 13 Pyruvate?

"Hyperpolarized Carbon C 13 Pyruvate is in Phase 2 of clinical trials, meaning that while there is evidence suggesting it is safe, none of the data collected supports efficacy."

Answered by AI

How many total participants are needed for this clinical trial?

"Yes, that is accurate. As per the information available on clinicaltrials.gov, this study was first posted on 7/18/2018 and is currently recruiting patients. The trial needs to recruit 60 individuals from 1 site."

Answered by AI

What is the purpose of this research?

"The goal of this study is to establish a correlation between intra-tumoral C-pyruvate and glutamate levels with Gleason grade. Additionally, the study seeks to understand variability in kPG levels within patients, incidence of adverse events, and intra-patient variability in kPL."

Answered by AI

Who else is applying?

What state do they live in?
California
How old are they?
65+
What site did they apply to?
University of California, San Francisco
What portion of applicants met pre-screening criteria?
Did not meet criteria
~9 spots leftby Mar 2025