About Bolder Science

Our mission is to provide healthcare professionals with unbiased clinical research information, easily.

Currently, you can access the following clinical trials being conducted worldwide:

359,057 studies
in
219 countries
Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/18/2021.
This website is for US healthcare professionals

Log In to Bolder Science

or

Don't have an account? Sign Up

Please enter your email address.

You will receive a link to create a new password via email.

Log In

Create an Account

or
(optional) ?

Welcome, !

Please complete the following 4 questions to ensure you receive the information that best suits your needs.

Clinical Trials of Interest

When I’m looking for information on clinical trials, I usually am interested in...

finding clinical trials in which to enroll my patients

Rarely Often

finding newly launched clinical trials (for all phases)

Rarely Often

updates on status changes for clinical trials

Rarely Often

pipeline molecules

Rarely Often

Drug Interventions

Enter up to 3 drug interventions you are currently interested in:

Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/18/2021.

Hyperpolarized Pyruvate (13C) MR Imaging in Monitoring Patients With Prostate Cancer on Active Surveillance

Clinicaltrials.gov identifier NCT03933670

Recruitment Status Recruiting

First Posted May 1, 2019

Last update posted July 24, 2020

Study Description

Brief summary:

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.

  • Condition or Disease:Prostate Adenocarcinoma
  • Intervention/Treatment: Drug: Hyperpolarized Carbon C 13 Pyruvate
    Procedure: Magnetic Resonance Spectroscopic Imaging
    Procedure: MRI Ultrasound Fusion Guided Biopsy
  • Phase: Phase 2
Detailed Description

PRIMARY OBJECTIVES: I. Optimize the imaging sequences that maximize signal-to-noise ratio (SNR) and intra-tumoral conversion of HP 13C pyruvate to lactate (kPL) and HP 13C pyruvate to glutamate (kPG) in regions of tumor versus (vs.) adjacent benign tissue as assessed by multi-parametric MRI (mpMRI) imaging characteristics. (Part 1) II. Determine the association between intra-tumoral kPL and kPG with Gleason grade determined during magnetic resonance (MR)/ultrasound (US)-guided fusion prostate biopsies obtained within 6 months following baseline HP C-13 pyruvate MR exam. (Part 2) SECONDARY OBJECTIVES: I. Evaluate the intra-patient variability in intra-tumoral kPL and kPG with repeated dose studies. II. Determine the association between peak intra-tumoral kPL observed on baseline imaging with serum prostate specific antigen (PSA). III. Compare and contrast intra-tumoral kPL and kPG with prostate imaging reporting and data system (PI-RADS) version 2 and individual mpMRI parameters including apparent diffusion coefficient (ADC) on diffusion-weighted imaging. IV. Describe the frequency of up-grading of tumor with MR/US-guided fusion biopsy obtained following baseline HP C-13 MR exam. V. Further characterize the safety profile of HP C-13 pyruvate injections. EXPLORATORY OBJECTIVES: I. Correlate peak intra-tumoral kPL with results of gene expression profiling using DECIPHER assay. II. Correlate peak intra-tumoral kPL and kPG with DECIPHER GRID tumor ribonucleic acid (RNA) expression of relevant components of the glycolytic pathway including lactate dehydrogenase (LDH), pyruvate dehydrogenase (PDH), aconitate hydratase (aconitase), myelocytomatosis oncogene (MYC), monocarboxylate transporter 4 (MCT4) (lactate transporter). III. For patients who undergo optional follow-up HP C-13 pyruvate/MRI 6-15 months following baseline scan, determine the mean percent change from baseline in intra-tumoral kPL and kPG and whether the change from baseline is associated change in clinical risk assessment as determined by University of California, San Francisco (UCSF)-Cancer of the Prostate Risk Assessment (CAPRA) risk score. OUTLINE: Patients receive hyperpolarized carbon C 13 pyruvate intravenously (IV) over less than one minute, then undergo magnetic resonance spectroscopic imaging (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. After completion of study, patients will be followed up periodically.

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 60 participants
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Diagnostic
  • Official Title: A Phase 2 Study of Magnetic Resonance (MR) Imaging With Hyperpolarized Pyruvate (13C) in Patients With Prostate Cancer on Active Surveillance
  • Actual Study Start Date: July 2018
  • Estimated Primary Completion Date: January 2021
  • Estimated Study Completion Date: January 2021
Arms and interventions
Arm Intervention/treatment
Experimental: Diagnostic (HP C-13 MRI)
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.
Drug: Hyperpolarized Carbon C 13 Pyruvate
Given IV

Procedure: Magnetic Resonance Spectroscopic Imaging
Undergo MRSI

Procedure: MRI Ultrasound Fusion Guided Biopsy
Undergo MR/US fusion-guided prostate biopsy
Outcome Measures
  • Primary Outcome Measures: 1. Signal-to-noise ratio (SNR) of hyperpolarized lactate [ Time Frame: At Baseline ]
    Assessed by multi-parametric magnetic resonance imaging (mpMRI) characteristics.
  • 2. Intra-tumoral C-pyruvate to lactate (kPL) [ Time Frame: At Baseline ]
    Assessed by multi-parametric magnetic resonance imaging (mpMRI) characteristics
  • 3. Intra-tumoral C-pyruvate to glutamate (kPG) [ Time Frame: At Baseline ]
    Assessed by multi-parametric magnetic resonance imaging (mpMRI) characteristics
  • 4. Association between intra-tumoral C-pyruvate to lactate (kPL) with Gleason grade [ Time Frame: Within 12 weeks following baseline HP C-13 pyruvate MR exam ]
    kPL will be compared with the pathologic Gleason grade determined using tissue from an MR/US-guided fusion prostate biopsy. Measured kPL will be compared by pathologic Gleason grade using an ANOVA model. If there is an overall difference, the Newman-Keuls post hoc test will be used to determine which tissue pairs differ.
  • 5. Association between intra-tumoral C-pyruvate to glutamate (kPG) with Gleason grade [ Time Frame: Within 12 weeks following baseline HP C-13 pyruvate MR exam ]
    kPG will be compared with the pathologic Gleason grade determined using tissue from an MR/US-guided fusion prostate biopsy. Measured kPG will be compared by pathologic Gleason grade using an ANOVA model. If there is an overall difference, the Newman-Keuls post hoc test will be used to determine which tissue pairs differ.
  • Secondary Outcome Measures: 1. Describe frequency of up-grading of tumor [ Time Frame: Within 12 weeks following baseline HP C-13 pyruvate MR exam ]
    Describe the frequency of up-grading of tumor with MR/US-guided fusion biopsy obtained following baseline HP C-13 MR exam
  • 2. Intra-patient variability in kPL [ Time Frame: Up to 15 months ]
    Intra-patient variability in the kPL will be summarized by the intraclass correlation and presented with a 90% confidence interval.
  • 3. Intra-patient variability in kPG [ Time Frame: Up to 15 months ]
    Intra-patient variability in the kPG will be summarized by the intraclass correlation and presented with a 90% confidence interval.
  • 4. Contrast between kPL and kPG in regions of tumor [ Time Frame: Up to 15 months ]
    The kPL and kPG will be contrasted in regions of tumor. Determined with prostate imaging reporting and data system (PI-RADS) version 2 classification score (1 through 5)
  • 5. Comparison of kPL and kPG with apparent diffusion coefficient in region of tumor [ Time Frame: Up to 15 months ]
    The kPL and kPG will be compared with apparent diffusion coefficient in region of tumor. Determined by comparison to peak intra-tumoral apparent diffusion coefficient (ADC) value
  • 6. Incidence of adverse events graded [ Time Frame: Up to 15 months ]
    According to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0.
  • 7. Association between peak intra-tumoral kPL observed on baseline imaging with serum PSA [ Time Frame: At Baseline ]
    Determine the association between peak intra-tumoral kPL observed on baseline imaging with serum PSA. The study cohort will be dichotomized by mean intra-tumoral kPL above and below the median and the mean serum PSA will be compared between the two dichotomized subgroups using Mann-Whitney test.
Eligibility Criteria
  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: Male
  • Accepts Healthy Volunteers: No
Criteria

Inclusion Criteria:

- The subject has biopsy-proven adenocarcinoma of the prostate with low to intermediate
risk disease by UCSF-CAPRA scoring at study entry

- For Part 1: Patient planning to enroll or currently on active surveillance; For Part
2: Currently enrolled on active surveillance with planned fusion biopsy within 12
weeks following completion of baseline HP C-13 pyruvate/mpMRI on study

- The subject is 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

- Absolute neutrophil count (ANC) >= 1000 cells/microliter (uL)

- Hemoglobin >= 9.0 gm/deciliter (dL)

- Platelets >= 75,000 cells/uL

- Estimated creatinine clearance* >= 50 milliliter (mL)/min

- by the Cockcroft Gault equation

- Total bilirubin =< 1.5 x upper limit of normal (ULN) or if =< 4 gm/dL and direct bilirubin is within normal limit (WNL) - Aspartate aminotransferase (AST) =< 1.5 x ULN - Alanine aminotransferase (ALT) = 160 mm Hg
systolic or > 100 mmg Hg diastolic. Treatment with anti-hypertensives and re-screening
is permitted

- 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)

- Congestive heart failure with New York Heart Association (NYHA) status >= 2

Contacts and Locations
Contacts

Contact: Priscilla Chan 877-827-3222 cancertrials@ucsf.edu

Locations

United States, California
University of California, San Francisco
San Francisco

Sponsors and Collaborators

University of California, San Francisco

National Cancer Institute (NCI)

National Institute for Biomedical Imaging and Bioengineering (NIBIB)

Investigators

Principal Investigator: Rahul R Aggarwal, MD University of California, San Francisco

More Information
  • Responsible Party: University of California, San Francisco
  • ClinicalTrials.gov Identifier: NCT03933670 History of Changes
  • Other Study ID Numbers: 175516, NCI-2018-02195, R01CA211150, R01EB017449
  • First Posted: May 1, 2019 Key Record Dates
  • Last Update Posted: July 24, 2020
  • Last Verified: July 2020
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Product Manufactured in and Exported from the U.S.: Yes
  • Additional relevant MeSH terms: Adenocarcinoma