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

M.D. Anderson Cancer Center

Status: Active, not recruiting

Conditions: Prostate Adenocarcinoma

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

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT04286386

NCI-2020-00746 (Registry Identifier)

2018-1164 (Other Identifier)

R01CA211150 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 130 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

130 participants in 3 patient groups

Arm Ia (MRSI)

Description:

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

Treatment:

Procedure: Magnetic Resonance Spectroscopic Imaging

Other: Hyperpolarized Carbon C 13 Pyruvate

Arm Ib (MRSI)

Description:

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.

Treatment:

Procedure: Magnetic Resonance Spectroscopic Imaging

Other: Hyperpolarized Carbon C 13 Pyruvate

Arm II (MRSI, surgery)

Description:

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.

Treatment:

Procedure: Magnetic Resonance Spectroscopic Imaging

Other: Hyperpolarized Carbon C 13 Pyruvate

Procedure: Surgical Procedure