Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01229618 | Hyperpolarized Pyruvate Injection in Subjects With Prostate Cancer | PHASE1 | COMPLETED | 31 | — | — | Oct 1, 2010 | Aug 1, 2013 | Oct 5, 2015 | 1 | United States |
Assessment of the occurrence of clinically significant changes in safety variables from baseline. Safety endpoints include monitoring for the occurrence of treatment-emergent AEs. Monitoring will occur to evaluate for dose-limiting toxicity. Dose-Limiting Toxicity (DLT) is defined as any toxicity greater than or equal to grade 2, 3 or 4, attributable to the imaging agent and occurring within 7 days after administration. The maximum tolerated dose will be the dose level at which \<33% DLT occurs.
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | 0.14 ml/kg bw - hyperpolarized pyruvate |
| 2 | EXPERIMENTAL | 0.28 ml/kg bw - hyperpolarized pyruvate |
| 3 | EXPERIMENTAL | 0.43 ml/kg bw - hyperpolarized pyruvate |
| Name | Type | Description |
|---|---|---|
| Hyperpolarized Pyruvate (13C) injection | DRUG | single hyperpolarized pyruvate IV (intravenous) injection followed by MR imaging scans (MRI and MRSI) |
INCLUSION CRITERIA: 1. The subject has biopsy-proven prostate cancer and is either undergoing active surveillance ("watchful waiting") or pre primary local treatment for prostate cancer (i.e., prior to either radiation therapy or radical prostatectomy). 2. The subject is able and willing to comply ...