A Phase 1 Pilot Study of 99mTc-MIP-1404 Single Photon Emission Computed Tomography (SPECT)/CT Imaging in Men With Prostate Cancer Undergoing Prostatectomy and/or Pelvic Lymph Node Dissection (PLND)
1. Male aged 21 years or older.
2. Ability to provide signed informed consent and willingness to comply with protocol
3. Past biopsy indicating the presence of adenocarcinoma of the prostate gland.
4. Participant is deemed to be high-risk with potential for pelvic lymph node
involvement. The criteria for high-risk are:
- Patient has PSA value >10 and clinical stage T2 or higher, and Gleason score 8,
9 or 10.
- Patient has PSA value >20 and clinical stage T2 or higher, and Gleason score
5. Participant is or will be scheduled to undergo standard of care prostatectomy and/or
pelvic lymph node dissection.
6. Have had (within previous 2 months) or will undergo diagnostic CT or MRI imaging
prior to surgery.
7. Have had (within previous 2 months) or will undergo bone scan imaging prior to
8. Participants must agree to use an acceptable form of birth control throughout the
study period. Participants must use condoms for a period of seven days after each
injection, if engaged in sexual activity.
1. Participants for whom participating would significantly delay the scheduled standard
of care therapy.
2. Participants administered a radioisotope within 5 physical half lives prior to study
3. Participants with 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.