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MR Imaging with Pyruvate for Prostate Cancer (pyruvate Trial)
Phase < 1
Recruiting
Led By Rahul Aggarwal, 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
Estimated creatinine clearance >= 50 mL/min (by the Cockcroft Gault equation)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 1 day
Awards & highlights
pyruvate Trial Summary
This trial is testing how well magnetic resonance spectroscopic imaging (MRSI) with hyperpolarized carbon C13 pyruvate works in finding and diagnosing localized high-grade prostate cancer in patients undergoing radical prostatectomy.
Who is the study for?
This trial is for men with biopsy-proven prostate cancer who are planning a radical prostatectomy at UCSF within 12 weeks. They must have good blood counts, liver and kidney function, and be able to undergo MRI/MRSI. Men with severe allergies, heart conditions, or those unable to give consent are excluded.Check my eligibility
What is being tested?
The study tests if Magnetic Resonance Spectroscopic Imaging (MRSI) using hyperpolarized carbon C13 pyruvate can accurately identify high-grade localized prostate cancer in patients scheduled for surgery.See study design
What are the potential side effects?
Potential side effects may include discomfort from the endorectal coil used during MRSI and reactions to gadolinium contrast if applicable. However, specific side effects related to hyperpolarized C13 pyruvate are not detailed here.
pyruvate Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
My kidneys are functioning well enough to clear waste.
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My prostate cancer was confirmed by a biopsy.
pyruvate Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 1 day
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 1 day
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Mean Urea AUC by Pathological grade
Mean lactate area under curve (AUC) by Pathological grade
Mean peak conversion of HP 13C pyruvate to lactate (kPL) by Pathological grade
+2 moreSecondary outcome measures
Compare lactate/pyruvate area under curve (AUC) with Prostate Imaging Reporting and Data System (PI-RADS)
Compare peak lactate/pyruvate with PI-RADS
Compare pyruvate to lactate (kPL) with PI-RADS
+13 moreSide effects data
From 2019 Phase 1 trial • 9 Patients • NCT0356536733%
Anosmia
33%
Dysgeusia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Healthy Volunteers
Known CNS Malignancy
pyruvate Trial Design
1Treatment groups
Experimental Treatment
Group I: Pre-surgical Prostate Cancer patientsExperimental Treatment3 Interventions
Infusion of co-hyperpolarized 13C pyruvate and undergo and hyperpolarized 13C, 15N urea injection prior to metabolic/perfusion High spatial resolution MRI/1H MRSI staging exam (PROSE) using both a phased-array abdominal coil and an endorectal coil will be performed within 12 weeks of subsequent radical prostatectomy. At least 20 patients will be required to have high risk disease as defined by primary Gleason score of 4 or 5 on prior prostate biopsy
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Magnetic Resonance Spectroscopic Imaging
2012
Completed Phase 1
~430
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Who is running the clinical trial?
University of California, San FranciscoLead Sponsor
2,506 Previous Clinical Trials
15,238,505 Total Patients Enrolled
51 Trials studying Prostate Cancer
16,983 Patients Enrolled for Prostate Cancer
Ivan de Kouchkovsky, MDLead Sponsor
1 Previous Clinical Trials
32 Total Patients Enrolled
1 Trials studying Prostate Cancer
32 Patients Enrolled for Prostate Cancer
National Cancer Institute (NCI)NIH
13,667 Previous Clinical Trials
40,926,116 Total Patients Enrolled
560 Trials studying Prostate Cancer
507,045 Patients Enrolled for Prostate Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I cannot have certain rectal procedures due to past surgery or allergies.I have heart failure or my condition limits my physical activity.I have a history of heart issues but not recent heart attacks or uncontrolled heart rhythm problems.I am fully active or restricted in physically strenuous activity but can do light work.My kidneys are functioning well enough to clear waste.I cannot have gadolinium contrast due to an allergy or kidney issues.My blood pressure is higher than 160/100 despite treatment.I am scheduled for a major prostate surgery at UCSF within 3 months after a special MRI.I have used hormone therapy for cancer, but stopped any 5-alpha reductase inhibitors over a month ago.I have had prostate cancer treatments but not TURP.My prostate cancer is high-risk based on a Gleason score of 4 or 5.My prostate cancer was confirmed by a biopsy.
Research Study Groups:
This trial has the following groups:- Group 1: Pre-surgical Prostate Cancer patients
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants are being monitored in this experiment?
"As of the last update on May 16th 2022, this trial is not currently open to new participants. If you are exploring other studies, 1322 prostate cancer trials and 9 Magnetic Resonance Spectroscopic Imaging studies are actively recruiting patients."
Answered by AI
Has this experiment begun recruiting individuals to participate?
"Unfortunately, this medical trial is not presently enrolling patients. Initially published on March 22nd 2016 and last edited May 16th 2022, the investigation has concluded its recruitment phase. However, at this time there are 1322 clinical trials for prostate cancer as well as 9 studies utilizing Magnetic Resonance Spectroscopic Imaging that remain active."
Answered by AI
What results is this research endeavoring to yield?
"This clinical trial's primary outcome to be evaluated at Baseline and 1 day is Mean Urea AUC by Pathological grade. Secondary endpoints include determining the Optimal cut-off value of urea transfer constant (ktrans) using Receiver-operative-curve analyses, assessing Intra-patient reproducibility of Urea AUC through summary statistics, as well as comparing peak pyruvate to lactate (kPL) on MRI with PI-RADS assessment for distinguishing between cancerous and noncancerous areas in prostate tissue."
Answered by AI
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