Active — Not RecruitingNot Applicable

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

United States130 participantsStarted 2019-12-19

Plain-language 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.

Who can participate

Age range18 Years

SexMALE

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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)

What they're measuring

Reproducibility of the kpl measurement

Timeframe: 3 years

Reproducibility of the normalized area under the lactate curve (nLac)

Timeframe: 3 years

Trial details

NCT IDNCT04286386

SponsorM.D. Anderson Cancer Center

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2028-04-30