Conditions: Prostate Cancer
Keywords: PROSTATE CANCER HIGH-RISK PROSTATECTOMY SURGERY NEWLY DIAGNOSED
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 105
Healthy volunteers: no

Brief summary:
This was a multicenter, multi-reader, open-label, Phase 2 study assessing the safety and performance characteristics of MIP 1404 imaging in the detection of prostate gland and pelvic lymph node cancer. Comparative performance characteristics between MIP 1404 imaging and MRI were also assessed, as judged by histopathology results.

Detailed description:
This is a single arm, open label study of approximately 100 high-risk prostate cancer patients scheduled for prostatectomy and extended pelvic lymph node dissection. Patients receive a single IV dose of 99mTc-MIP-1404 (study drug) followed by SPECT/CT scan 3-6 hours after injection. As standard of care, patients will undergo prostatectomy and extended pelvic lymph node dissection (EPLND) within three weeks of study drug dosing. 99mTc-MIP-1404 image data will be evaluated for visible uptake and compared with histopathology.

Arms:
arm 1: 20 ±3 mCi intravenous (IV) injection of 99mTc-MIP-1404

Interventions: intervention 1: Drug: 99mTc-MIP-1404
Intervention descriptions: intervention 1: A single dose of 20 ±3 mCi intravenous (IV) injection of 99mTc-MIP-1404

Protocol document: