Hyperpolarized Carbon C 13 Pyruvate Magnetic Resonance Spectroscopic Imaging in Predicting Treatment Response in Patients With Prostate Cancer
- Conditions
- PSA Level Greater Than TenStage IIIB Prostate Cancer AJCC v8Stage IIIC Prostate Cancer AJCC v8Stage IVA Prostate Cancer AJCC v8Stage IV Prostate Cancer AJCC v8Stage IVB Prostate Cancer AJCC v8Prostate AdenocarcinomaStage III Prostate Cancer AJCC v8Stage IIB Prostate Cancer AJCC v8Stage IIIA Prostate Cancer AJCC v8
- Interventions
- Procedure: Magnetic Resonance Spectroscopic Imaging
- Registration Number
- NCT03581500
- Lead Sponsor
- M.D. Anderson Cancer Center
- Brief Summary
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).
- Detailed 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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- Male
- Target Recruitment
- 2
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Diagnostic (hyperpolarized carbon C 13 pyruvate MRSI) Magnetic Resonance Spectroscopic Imaging Patients receive hyperpolarized carbon C 13 pyruvate IV over 10-20 seconds and undergo MRSI over 2-3 minutes at 6 and 8 weeks. Diagnostic (hyperpolarized carbon C 13 pyruvate MRSI) Hyperpolarized Carbon C 13 Pyruvate Patients receive hyperpolarized carbon C 13 pyruvate IV over 10-20 seconds and undergo MRSI over 2-3 minutes at 6 and 8 weeks.
- Primary Outcome Measures
Name Time Method Reproducibility of the key performance indicator Up to 3 years
- Secondary Outcome Measures
Name Time Method Sensitivity assessed by comparison to biopsy Up to 3 years The location of signal by hyperpolarized 13-C-pyruvate will be compared to location of tumor at biopsy or if available, follow-up surgical pathology in patients who did not receive interval additional prostate directed therapy, such as hormonal or radiation therapy.
Specificity assessed by comparison to biopsy Up to 3 years The location of signal by hyperpolarized 13-C-pyruvate will be compared to location of tumor at biopsy or if available, follow-up surgical pathology in patients who did not receive interval additional prostate directed therapy, such as hormonal or radiation therapy.
Trial Locations
- Locations (1)
M D Anderson Cancer Center
🇺🇸Houston, Texas, United States