Hyperpolarized Carbon C 13 Pyruvate Magnetic Resonance Spectroscopic Imaging in Predicting Treatment Response in Patients With Prostate Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-06

Study Completion Date

2024-10-16

Brief Summary

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This phase II trial studies how well hyperpolarized carbon C 13 pyruvate magnetic resonance spectroscopic imaging works in predicting treatment response in patients with prostate cancer. Hyperpolarized carbon C 13 pyruvate magnetic resonance spectroscopic imaging may help to accurately predict how prostate cancer patients will respond to standard therapy (abiraterone and apalutamide).

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Detailed Description

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PRIMARY OBJECTIVE:

I. To assess reproducibility of quantitative spectroscopic and imaging parameters in hyperpolarized 13-C pyruvate magnetic resonance spectroscopic imaging (MRSI), including key performance indicator (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.

SECONDARY OBJECTIVE:

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.

OUTLINE:

Patients receive hyperpolarized carbon C 13 pyruvate intravenously (IV) over 10-20 seconds and undergo MRSI over 2-3 minutes at 6 and 8 weeks.

After completion of study, patients are followed up at 1 day and then for up to 3 years.

Conditions

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Prostate Adenocarcinoma PSA Level Greater Than Ten Stage IIB Prostate Cancer AJCC v8 Stage III Prostate Cancer AJCC v8 Stage IIIA Prostate Cancer AJCC v8 Stage IIIB Prostate Cancer AJCC v8 Stage IIIC Prostate Cancer AJCC v8 Stage IV Prostate Cancer AJCC v8 Stage IVA Prostate Cancer AJCC v8 Stage IVB Prostate Cancer AJCC v8

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Diagnostic (hyperpolarized carbon C 13 pyruvate MRSI)

Patients receive hyperpolarized carbon C 13 pyruvate IV over 10-20 seconds and undergo MRSI over 2-3 minutes at 6 and 8 weeks.

Group Type EXPERIMENTAL

Hyperpolarized Carbon C 13 Pyruvate

Intervention Type DRUG

Given IV

Magnetic Resonance Spectroscopic Imaging

Intervention Type PROCEDURE

Undergo MRSI

Interventions

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Hyperpolarized Carbon C 13 Pyruvate

Given IV

Intervention Type DRUG

Magnetic Resonance Spectroscopic Imaging

Undergo MRSI

Intervention Type PROCEDURE

Other Intervention Names

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Hyperpolarized 13C-Pyruvate Hyperpolarized Pyruvate (13C) 1H- Nuclear Magnetic Resonance Spectroscopic Imaging 1H-nuclear magnetic resonance spectroscopic imaging Magnetic Resonance Spectroscopy MRS MRS Imaging MRSI Proton Magnetic Resonance Spectroscopic Imaging

Eligibility Criteria

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Inclusion Criteria

* Biopsy proven high risk prostate adenocarcinoma, or de novo metastatic previously untreated naive prostate cancer (patients who have initiated gonadotrophin releasing hormone \[Lhrh\] analog or antagonist within the past 4 weeks are eligible)
* Gleason \>= 8 OR Gleason 7 + \>= cT2b + prostate specific antigen (PSA) \> 10 ng/ml
* Prior prostate biopsy must have been performed at least 4 weeks prior

Exclusion Criteria

* Contraindication to MRI
* Estimated glomerular filtration rate (eGFR) \< 30
* Allergy to gadavist intravenous contrast
* History of cardiac arrhythmia
* Since they do not get prostate cancer, women are excluded; thus, pregnancy is not an issue

Eligible Sex

MALE

Accepts Healthy Volunteers

No