Pilot Study of 99mTc-MIP-1404 SPECT/CT Imaging in Men With Prostate Cancer Undergoing Prostatectomy and/or Pelvic Lymph Node Dissection

Inclusion criteria

• Male aged 21 years or older.
• Ability to provide signed informed consent and willingness to comply with protocol requirements.
• Past biopsy indicating the presence of adenocarcinoma of the prostate gland.
• 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
• Participant is or will be scheduled to undergo standard of care prostatectomy and/or pelvic lymph node dissection.
• Have had (within previous 2 months) or will undergo diagnostic CT or MRI imaging prior to surgery.
• Have had (within previous 2 months) or will undergo bone scan imaging prior to surgery.
• 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.

Exclusion criteria

• Participants for whom participating would significantly delay the scheduled standard of care therapy.
• Participants administered a radioisotope within 5 physical half lives prior to study enrollment.
• 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.