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

M.D. Anderson Cancer Center

Status and phase: Withdrawn; Phase 2

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

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03581500

2017-0403 (Other Identifier)

NCI-2018-01096 (Registry Identifier)

Details and patient eligibility

About

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).

Full description

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.

Sex: Male

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

0 participants in 1 patient group

Diagnostic (hyperpolarized carbon C 13 pyruvate MRSI)

Experimental group

Description:

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

Treatment:

Drug: Hyperpolarized Carbon C 13 Pyruvate

Procedure: Magnetic Resonance Spectroscopic Imaging