Houston, Texas 77030


Purpose:

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).


Study summary:

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.


Criteria:

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


NCT ID:

NCT03581500


Primary Contact:

Principal Investigator
Vikas Kundra
M.D. Anderson Cancer Center

Vikas Kundra
Phone: 713-745-2702
Email: vkundra@mdanderson.org


Backup Contact:

N/A


Location Contact:

Houston, Texas 77030
United States

Vikas Kundra
Phone: 713-745-2702

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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