Prostate Cancer
Conditions
Brief summary
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.
Interventions
DRUG99mTc MIP 1404
A single dose of 20 ±3 mCi intravenous (IV) injection of 99mTc MIP 1404
Sponsors
Molecular Insight Pharmaceuticals, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
21 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tissue distribution of 99mTc-MIP-1404 SPECT/CT imaging in tumor and non-tumorous regions of the prostate | Within 3-6 hours of dosing SPECT/CT images will be taken | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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 | Summary tables will present change from pre-dose to post-dose vital signs measurements. |
| 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 | To obtain exploratory tissue distribution of 99mTc-MIP-1404 SPECT/CT imaging in tumor and non-tumorous regions of pelvic lymph node |
| Intensity of 99mTc-MIP-1404 uptake with respect to PSMA expression | PSMA expression analysis will be conducted upon completion of enrollment | Evaluate the intensity of 99mTc-MIP-1404 uptake with respect to PSMA expression |
Countries
United States
Outcome results
None listed