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

NCT04286386 | Active Not Recruiting FDA Drug

• 3 other identifiers: 2018-1164NCI-2020-00746R01CA211150
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prostate Adenocarcinoma

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Specificity of HP 13-C-pyruvate MRSI for detecting high risk localized prostate cancer

  3 years

• Sensitivity of hyperpolarized (HP) 13-C-pyruvate magnetic resonance spectroscopy imaging (MRSI) for detecting high risk localized prostate cancer

  3 years

• Kpl

  3 years

Study Arms (3)

Arm Ia (MRSI)

Patients receive hyperpolarized carbon C 13 pyruvate IV and undergo MRSI at least 5 weeks after prostate cancer biopsy.

Other: Hyperpolarized Carbon C 13 Pyruvate; Procedure: Magnetic Resonance Spectroscopic Imaging

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.

Other: Hyperpolarized Carbon C 13 Pyruvate; Procedure: Magnetic Resonance Spectroscopic Imaging

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.

Other: Hyperpolarized Carbon C 13 Pyruvate; Procedure: Magnetic Resonance Spectroscopic Imaging; Procedure: Surgical Procedure

Interventions

Hyperpolarized Carbon C 13 Pyruvate OTHER

Given IV

Also known as: Hyperpolarized 13C-Pyruvate, Hyperpolarized Pyruvate (13C)

Arm II (MRSI, surgery); Arm Ia (MRSI); Arm Ib (MRSI)

Magnetic Resonance Spectroscopic Imaging PROCEDURE

Undergo MRSI

Also known as: 1H- Nuclear Magnetic Resonance Spectroscopic Imaging, 1H-nuclear magnetic resonance spectroscopic imaging, Magnetic Resonance Spectroscopy, MRS, MRS Imaging, MRSI, proton magnetic resonance spectroscopic imaging

Arm II (MRSI, surgery); Arm Ia (MRSI); Arm Ib (MRSI)

Surgical Procedure PROCEDURE

Undergo standard of care surgery

Also known as: Operation, surgery, Surgical, Surgical Interventions, Surgical Procedures, Type of Surgery

Arm II (MRSI, surgery)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• MD Anderson Cancer Center Website

MeSH Terms

Interventions

Magnetic Resonance Spectroscopy; Surgical Procedures, Operative

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Tharakeswara Bathala

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2020
• First Posted: February 27, 2020
• Study Start: December 19, 2019
• Primary Completion (Estimated): April 30, 2026
• Study Completion (Estimated): April 30, 2026
• Last Updated: April 16, 2026

Record last verified: 2026-04

Locations

US (1)