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
Conditions
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.
Interventions
Given IV
PROCEDUREMagnetic Resonance Spectroscopic Imaging
Undergo MRSI
Sponsors
National Cancer Institute (NCI)
M.D. Anderson Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
MALE
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reproducibility of the key performance indicator | Up to 3 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed