Clinical trial NCT04286386: Development and Evaluation of a Quantitative HP MRI for Clinical Prostate Cancer Exam
Official title: Development &Amp; Evaluation of a Quantitative HP MRI Clinical Prostate Cancer Exam
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Prostate Adenocarcinoma
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2020-02-27
Enrollment: 130
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Reproducibility of the kpl measurement
timeFrame: 3 years
measure: Reproducibility of the normalized area under the lactate curve (nLac)
timeFrame: 3 years
Secondary outcomes:
measure: Specificity of HP 13-C-pyruvate MRSI for detecting high risk localized prostate cancer
timeFrame: 3 years
measure: Sensitivity of hyperpolarized (HP) 13-C-pyruvate magnetic resonance spectroscopy imaging (MRSI) for detecting high risk localized prostate cancer
timeFrame: 3 years
measure: Kpl
timeFrame: 3 years
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Tharakeswara Bathala
role: PRINCIPAL_INVESTIGATOR
References: