A Phase 2 Assessment of the Diagnostic Accuracy of 99mTc-MIP-1404 Imaging in Men With High-Risk Prostate Cancer Scheduled for Radical Prostatectomy (RP) and Extended Pelvic Lymph Node Dissection (EPLND) Compared to Histopathology

Location:

Rochester, Minn.

Trial status:
Open for Enrollment
Why is this study being done?

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.

Who is eligible to participate?

Inclusion Criteria: - Male aged 21 years or older. - Ability to provide signed informed consent and willingness to comply with protocol requirements. - Biopsy confirmed presence of adenocarcinoma of the prostate gland. - At high-risk for metastatic disease by a stage of cT3, cT4, or a total nomogram score of greater than or equal to 130. - Scheduled to undergo radical prostatectomy with extended pelvic lymph node dissection. - Agree to use an acceptable form of birth control for a period of 7 days after the 99mTc MIP-1404 injection. Exclusion Criteria: - Participating would significantly delay the scheduled standard of care therapy. - Administered a radioisotope within 5 physical half lives prior to study drug injection. - Have any medical condition or other circumstances that, in the opinion of the investigator, would significantly decrease obtaining reliable data, achieving study objectives or completing the study. - Have a contraindication for MR imaging.

Last updated:
8/21/2013
NCT ID:
NCT01667536