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

Running, not enrolling

Conditions studied: Prostate Adenocarcinoma

In brief

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.

Key facts

Study ID

NCT04286386

Run by

M.D. Anderson Cancer Center

People needed

130

Starts

2019-12-19

Expected to finish

2028-04-30

Last updated by the study team

2026-04-29

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

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)

Where it is running

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

Full record on ClinicalTrials.gov

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