Clinical trial · Interventional
Hyperpolarized Carbon C 13 Pyruvate Magnetic Resonance Spectroscopic Imaging in Predicting Treatment Response in Patients With Prostate Cancer
Hyperpolarized 13-C-Pyruvate Magnetic Resonance Spectroscopic Imaging Reproducibilty Pilot in Patients With Prostate Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Committee could not find that the regulatory approval are met to re-approve this study.
Summary
Brief summary (as posted)
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).
Conditions
Conditions (10)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Adenocarcinoma | Prostate Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| PSA Level Greater Than Ten | — | UNRESOLVED | — |
| Stage IIB Prostate Cancer AJCC v8 | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIIA Prostate Cancer AJCC v8 | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIIB Prostate Cancer AJCC v8 | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIIC Prostate Cancer AJCC v8 | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
| Stage III Prostate Cancer AJCC v8 | Malignant Prostate Neoplasm | CURATED_BROADER |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hyperpolarized Carbon C 13 Pyruvate | Drug | — | UNRESOLVED |
| Magnetic Resonance Spectroscopic Imaging | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Diagnostic (hyperpolarized carbon C 13 pyruvate MRSI)
- 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.
- interventionNames
- Drug: Hyperpolarized Carbon C 13 Pyruvate
- Procedure: Magnetic Resonance Spectroscopic Imaging
Primary outcomes (1)
- measure
- Reproducibility of the key performance indicator
- timeFrame
- Up to 3 years
Secondary outcomes (2)
- measure
- Sensitivity assessed by comparison to biopsy
- timeFrame
- Up to 3 years
- description
Eligibility
Eligibility (as posted)
- Sex
- Male
Show eligibility criteria text
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
References
Publications (0)
Data not yet available