Development and Evaluation of a Quantitative HP MRI for Clinical Prostate Cancer Exam

Development &Amp; Evaluation of a Quantitative HP MRI Clinical Prostate Cancer Exam

This trial examines if a prostate magnetic resonance spectroscopic imaging can be performed on a 3T scanner using an investigational contrast called hyperpolarized 13-C pyruvate for the development of a clinical prostate cancer exam. 3T refers to the strength of the magnetic resonance spectroscopic imaging (MRSI) machine. MRSI is a magnetic resonance imaging (MRI) technique that can show certain chemical differences in healthy and diseased prostate tumor tissue compared to standard multiparametric MRI that may not detect the tumor. Hyperpolarized (HP) 13-C pyruvate is a contrast drug that may help the scanner see the tumor site better during imaging. Hyperpolarization of 13-C pyruvate may allow pyruvate and its metabolites to be detected upon injection, which in turn, allow the prostate cancer to be found and treated.

Study Overview

• Status: Active, not recruiting
• Conditions: Prostate Adenocarcinoma
• Intervention / Treatment: Procedure: Surgical Procedure; Procedure: Magnetic Resonance Spectroscopic Imaging; Other: Hyperpolarized Carbon C 13 Pyruvate

Detailed Description

PRIMARY OBJECTIVES:

I. To assess reproducibility of quantitative spectroscopic and imaging parameters in hyperpolarized 13-C pyruvate magnetic resonance spectroscopic imaging (MRSI), including kpl, which assesses the rate of conversion of 13-C pyruvate to 13-C lactate in the tissue of interest, using a test-retest study design.

II. To test the reproducibility of the normalized area under the lactate curve (nLac), a semi-quantitative biomarker for tumor metabolism.

SECONDARY OBJECTIVES:

I. To provide initial assessment of the sensitivity and specificity of hyperpolarized 13-C-pyruvate MRSI performed pre-therapy for detecting high risk localized prostate cancer.

II. To assess the correlation between kpl and tumor grade.

OUTLINE: Patients are assigned to 1 of 3 arms.

ARM Ia: Patients receive hyperpolarized carbon C 13 pyruvate intravenously (IV) and undergo MRSI at least 5 weeks after prostate cancer biopsy.

ARM Ib: Patients receive hyperpolarized carbon C 13 pyruvate IV and undergo MRSI at least 5 weeks after prostate cancer biopsy and at a second time 3-4 weeks after.

ARM II: Patients receive hyperpolarized carbon C 13 pyruvate IV and undergo MRSI at least 5 weeks after prostate cancer biopsy, followed by standard of care surgery within 6 months after.

After the completion of study, patients in Arm Ia and Arm Ib are followed up once.

• Study Type: Observational
• Enrollment (Estimated): 130

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • M D Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with biopsy proven prostate cancer that are enrolled in an active surveillance protocol, and patients that are scheduled for prostatectomy at MD Anderson

Description

Inclusion Criteria:

• Biopsy proven prostate adenocarcinoma (Arm 1 & 2)
• Clinically appropriate for active surveillance (Arm 1)
• Prior prostate biopsy must have been performed at least 5 weeks prior imaging (Arm 1 & 2)
• Patient must be scheduled to undergo radical prostatectomy within 6 months of multi-parametric magnetic resonance imaging (MP-MRI) + hyperpolarized (HP) [1-13C]-pyruvate imaging, consistent with American College of Radiology Imaging Network (ACRIN) Protocol: ACRIN 6659 (Arm 2)
• At least 10% of enrolled patients will have high risk of disease progression (Cancer of the Prostate Risk Assessment - [CAPRA] 6-10) and no more than 50% of enrolled patients will have low risk of progression (CAPRA < 3) (Arm 2)

Exclusion Criteria:

• Contraindication to MRI (Arm 1 & 2)
• Allergy to gadavist intravenous contrast (Arm 1 & 2)
• Any known medical history of arrhythmias such as atrial fib, etc. (Arm 1 & 2)
• Prior therapy for prostate cancer, except for 5-alpha reductase inhibitor discontinued at least one month prior to imaging (Arm 1 & 2)

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Arm Ia (MRSI); Patients receive hyperpolarized carbon C 13 pyruvate IV and undergo MRSI at least 5 weeks after prostate cancer biopsy.	Procedure: Magnetic Resonance Spectroscopic Imaging; Undergo MRSI; Other Names: proton magnetic resonance spectroscopic imaging; 1H- Nuclear Magnetic Resonance Spectroscopic Imaging; 1H-nuclear magnetic resonance spectroscopic imaging; Magnetic Resonance Spectroscopy; MRS; MRS Imaging; MRSI; Other: Hyperpolarized Carbon C 13 Pyruvate; Given IV; Other Names: Hyperpolarized 13C-Pyruvate; Hyperpolarized Pyruvate (13C)
Arm Ib (MRSI); Patients receive hyperpolarized carbon C 13 pyruvate IV and undergo MRSI at least 5 weeks after prostate cancer biopsy and at a second time 3-4 weeks after.	Procedure: Magnetic Resonance Spectroscopic Imaging; Undergo MRSI; Other Names: proton magnetic resonance spectroscopic imaging; 1H- Nuclear Magnetic Resonance Spectroscopic Imaging; 1H-nuclear magnetic resonance spectroscopic imaging; Magnetic Resonance Spectroscopy; MRS; MRS Imaging; MRSI; Other: Hyperpolarized Carbon C 13 Pyruvate; Given IV; Other Names: Hyperpolarized 13C-Pyruvate; Hyperpolarized Pyruvate (13C)
Arm II (MRSI, surgery); Patients receive hyperpolarized carbon C 13 pyruvate IV and undergo MRSI at least 5 weeks after prostate cancer biopsy, followed by standard of care surgery within 6 months after.	Procedure: Surgical Procedure; Undergo standard of care surgery; Other Names: Operation; Surgical; Surgical Interventions; Surgical Procedures; Type of Surgery; surgery; Procedure: Magnetic Resonance Spectroscopic Imaging; Undergo MRSI; Other Names: proton magnetic resonance spectroscopic imaging; 1H- Nuclear Magnetic Resonance Spectroscopic Imaging; 1H-nuclear magnetic resonance spectroscopic imaging; Magnetic Resonance Spectroscopy; MRS; MRS Imaging; MRSI; Other: Hyperpolarized Carbon C 13 Pyruvate; Given IV; Other Names: Hyperpolarized 13C-Pyruvate; Hyperpolarized Pyruvate (13C)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reproducibility of the kpl measurement	Will be assessed using a test-retest study design. Will be summarized by the intra-class correlation coefficient (ICC). Data from patients at both MD Anderson and University of San Fransisco, San Fransisco (UCSF) will be pooled if possible to increase significance. Bland-Altman analysis will be included if the ICC proves unreliable as a measure of reproducibility. ICC is sensitive to data range; thus, Bland-Altman plot, limits of agreement, repeatability coefficient, and the within-patient coefficient of variation (wCV) may be included as appropriate.	3 years
Reproducibility of the normalized area under the lactate curve (nLac)	Will be carried out using data from N=40 patients on active surveillance at MD Anderson. Will be summarized by the ICC. Data from patients at both MD Anderson and University of San Fransisco, San Fransisco (UCSF) will be pooled if possible to increase significance. Bland-Altman analysis will be included if the ICC proves unreliable as a measure of reproducibility. ICC is sensitive to data range; thus, Bland-Altman plot, limits of agreement, repeatability coefficient, and the within-patient coefficient of variation (wCV) may be included as appropriate.	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Specificity of HP 13-C-pyruvate MRSI for detecting high risk localized prostate cancer	Analysis will be restricted to lesions > 0.5 cc and the 3 most significant pathologic cancer foci from each patient. Specificity will be calculated as the ratio of true negatives to the sum of true negatives and false positives. Specificity will be assessed using pooled data from MD Anderson (N=25) and UCSF (N=25). A ROC analysis will be carried out.	3 years
Sensitivity of hyperpolarized (HP) 13-C-pyruvate magnetic resonance spectroscopy imaging (MRSI) for detecting high risk localized prostate cancer	Analysis will be restricted to lesions > 0.5 cc and the 3 most significant pathologic cancer foci from each patient. Sensitivity will be calculated as the ratio of true positives (matches) to the sum of true positives and false negatives. Sensitivity will be assessed using pooled data from MD Anderson (N=25) and UCSF (N=25). A receiver operating characteristic (ROC) analysis will be carried out.	3 years
Kpl	Correspondence between kpl, imaging biomarkers from the multiparametric MRI exam, and tumor grade will be assessed. Imaging biomarkers will be compared with pathologic grade (benign, Epstein grade grouping 1; intermediate, Epstein 2-3; and high-grade, Epstein 4-5) using analysis of variance (ANOVA) with Newman-Keuls post-hoc test to determine associations.	3 years

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Tharakeswara Bathala, M.D. Anderson Cancer Center

Publications and helpful links

Helpful Links

• MD Anderson Cancer Center Website

Study record dates

Study Major Dates

• Study Start (Actual): December 19, 2019
• Primary Completion (Estimated): April 30, 2028
• Study Completion (Estimated): April 30, 2028

Study Registration Dates

• First Submitted: February 24, 2020
• First Submitted That Met QC Criteria: February 24, 2020
• First Posted (Actual): February 27, 2020

Study Record Updates

• Last Update Posted (Actual): April 29, 2026
• Last Update Submitted That Met QC Criteria: April 28, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Carcinoma; Adenocarcinoma; Investigative Techniques; Chemistry Techniques, Analytical; Spectrum Analysis; Magnetic Resonance Spectroscopy; Surgical Procedures, Operative
• Other Study ID Numbers: 2018-1164 (Other Identifier: M D Anderson Cancer Center); R01CA211150 (U.S. NIH Grant/Contract); NCI-2020-00746 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No