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

Study Overview
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Brief Summary
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This is a single arm, open label study of up to 24 high risk prostate cancer patients scheduled for prostatectomy and/or 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/or pelvic lymph node dissection (PLND) within two weeks of study drug dosing. Patients may receive a second injection of study drug within 24 hours of surgery to measure activity counts in tissue samples post-surgery, but prior to pathology processing. 99mTc-MIP-1404 image data will be evaluated for visible uptake and compared with histopathology.

Official Title
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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)

Conditions
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Prostate Cancer

Intervention / Treatment
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* Drug: 99mTc-MIP-1404


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 20 (±3) mCi of study drug<br> | Drug: 99mTc-MIP-1404<br>* 20 (±3) mCi of study drug will be administered by IV injection as a slow bolus and flushed with approximately 10 mL of saline<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tissue distribution of 20 (± 3) mCi 99mTc-MIP-1404 | 99mTc-MIP-1404 image data will be evaluated for visible uptake and compared with histopathology. | Post-procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of 99mTc-MIP-1404: Change in Vital Signs from Pre-Dose to Post-Dose | Summary tables will present change from pre-dose to post-dose vital signs measurements. | Vital signs measurements will be measured, an expected average of 30 minutes before and after study drug injection | 
| Intensity of 99mTc-MIP-1404 Uptake with Respect to PSMA expression | 99mTc-MIP-1404 image data will be evaluated for visible uptake and compared with histopathology. | Post-procedure | 
| Safety of 99mTc-MIP-1404: Summary of Treatment-Emergent Adverse Events (TEAEs) | TEAEs will be summarized by the Medical Dictionary for Regulatory Activities (MedDRA) body system and preferred term, by intensity, and by causal relationship to study agent. | Adverse events will be assessed for the duration of the study participation, an expected average of 3 weeks |