A Phase 1 Pilot Study of 99mTc-MIP-1404 SPECT/CT Imaging to Histology in Men With Prostate Cancer

Study Overview
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Brief Summary
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This is a single arm, open label study of up to 24 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. 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 Comparison Study of 99mTc-MIP-1404 Single Photon Emission Computed Tomography (SPECT)/CT Imaging to Histology in Men With Prostate Cancer

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 have tissue suspicious of prostate cancer involvement that is amenable to biopsy/resection. Have had, or will undergo diagnostic CT or MRI 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 study drug administration, 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: Drug: 99mTc-MIP-1404<br>20 ±3 mCi intravenous (IV) injection of 99mTc MIP 1404 | Drug: 99mTc MIP 1404<br>* A single dose of 20 ±3 mCi intravenous (IV) injection of 99mTc MIP 1404<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tissue distribution of 99mTc-MIP-1404 SPECT/CT imaging in tumor and non-tumorous regions of the prostate | Tissue distribution of 99mTc-MIP-1404 SPECT/CT imaging in tumor and non-tumorous regions of the prostate (as determined by histopathology) in patients undergoing standard of care prostatectomy | Within 3-6 hours of dosing SPECT/CT images will be taken | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of 99mTc-MIP-1404 will be assessed by measuring Vital Signs (blood pressure and heart rate)Pre-Dose and Post-Dose as well as between 3-6 hours post-dose | Summary tables will present change from pre-dose to post-dose vital signs measurements. | Vital signs measurements will be taken, an expected average of 30 minutes before and after study drug injection and between 3-6 hours after study drug injection | 
| Tissue distribution of 99mTc-MIP-1404 SPECT/CT imaging in tumor and non-tumorous regions of pelvic lymph node | To obtain exploratory tissue distribution of 99mTc-MIP-1404 SPECT/CT imaging in tumor and non-tumorous regions of pelvic lymph node | Within 3-6 hours of dosing SPECT/CT images will be taken | 
| Intensity of 99mTc-MIP-1404 uptake with respect to PSMA expression | Evaluate the intensity of 99mTc-MIP-1404 uptake with respect to PSMA expression | PSMA expression analysis will be conducted upon completion of enrollment |