Study to Evaluate 99mTc-MIP-1404 SPECT/CT Imaging in Men With Biopsy Proven Low-Grade Prostate Cancer
- Conditions
- Prostate Cancer
- Interventions
- Drug: 99mTc-MIP-1404 InjectionDiagnostic Test: Whole-Body Planar and pelvic SPECT/CT scan
- Registration Number
- NCT02615067
- Lead Sponsor
- Molecular Insight Pharmaceuticals, Inc.
- Brief Summary
99mTc-MIP-1404 is a radioactive diagnostic imaging agent indicated for imaging men with newly diagnosed prostate cancer whose biopsy indicates a histopathologic Gleason Score of ≤ 3+4 severity who are candidates for active surveillance and are undergoing voluntary radical prostatectomy (RP) \[Cohort A\] or routine prostate biopsy \[Cohort B\]. This Phase 3 study is designed to evaluate the specificity and sensitivity of 99mTc-MIP-1404 SPECT/CT imaging to correctly identify subjects with previously unknown clinically significant prostate cancer.
- Detailed Description
This is a multi-center, multi-reader, open-label trial, comparing 99mTc-MIP-1404 SPECT/CT imaging in men who have had a diagnostic trans-rectal ultrasound (TRUS) guided biopsy with a histopathologic finding of Gleason score ≤3+4 who are candidates for active surveillance and are undergoing routine biopsy or voluntary RP with or without a pelvic lymph node dissection (PLND). This study will evaluate the sensitivity and specificity of 99mTc-MIP-1404 SPECT/CT image assessments to correctly identify subjects with previously unknown clinically significant prostate cancer in two cohorts: (1) Low grade prostate cancer who have elected to undergo RP \[Cohort A\]; and (2) very low risk (VLR) prostate cancer per 2016 NCCN Guidelines who are scheduled to undergo routine prostate biopsy \[Cohort B\].
Subjects will receive a single dose of 99mTc-MIP-1404 Injection (study drug) followed by whole body planar and SPECT/CT (pelvic) imaging 3-6 hours after injection. In accordance with standard of care procedures, subjects will undergo either voluntary RP \[Cohort A\] or prostate biopsy \[Cohort B\] within 42 days after study drug dosing. 99mTc-MIP-1404 image data will be collected by a central imaging core laboratory and evaluated for visible uptake within the prostate gland. These findings will then be compared against central histopathology as the truth standard. The central imaging core lab independent readers for the SPECT/CT scans will be blinded to all clinical data, including pathology results. Likewise, central pathologists are to remain blinded to all clinical data, including imaging results.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 531
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 99mTc-MIP-1404 Injection Whole-Body Planar and pelvic SPECT/CT scan 20 ± 3 millicurie (mCi) intravenous (IV) injection of 99mTc-MIP-1404 99mTc-MIP-1404 Injection 99mTc-MIP-1404 Injection 20 ± 3 millicurie (mCi) intravenous (IV) injection of 99mTc-MIP-1404
- Primary Outcome Measures
Name Time Method Specificity of 99mTc-MIP-1404 to detect clinically significant prostate cancer when compared to histopathology following either RP [Cohort A] or prostate biopsy [Cohort B] Within 3-6 hours of dosing, SPECT/CT and whole body planar images will be taken Tissue distribution of 99mTc-MIP-1404 SPECT/CT imaging in tumor and non-tumorous regions of the prostate and pelvic lymph nodes, if applicable, (as determined by histopathology) in patients undergoing RP (with or without extended pelvic lymph node dissection) or routine prostate biopsy. Pathology results will be used as the truth standard for all imaging analyses.
Sensitivity of 99mTc-MIP-1404 to detect clinically significant prostate cancer when compared to histopathology following either RP [Cohort A] or prostate biopsy [Cohort B] Within 3-6 hours of dosing, SPECT/CT and whole body planar images will be taken Tissue distribution of 99mTc-MIP-1404 SPECT/CT imaging in tumor and non-tumorous regions of the prostate and pelvic lymph nodes (as determined by histopathology) in patients undergoing standard of care prostatectomy with or without extended pelvic lymph node dissection. Pathology results will be used as the truth standard for all imaging analyses.
- Secondary Outcome Measures
Name Time Method Clinical safety of 99mTc-MIP-1404 Changes in vital signs and clinical laboratory test results from time of screening until pre-surgery (Day 0 - 42). Treatment-emergent adverse events from study drug injection until pre-surgery or pre-biopsy (within 42 days) Clinical laboratory tests will include hematology and clinical chemistry. Vital signs will include heart rate, blood pressure, temperature and respiration rate.
Specificity of 99mTc-MIP-1404 in prostate segments as compared to histopathology following RP [Cohort A only] Within 3-6 hours of dosing, SPECT/CT and whole body planar 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)
Sensitivity of 99mTc-MIP-1404 in prostate segments as compared to histopathology following RP [Cohort A only] Within 3-6 hours of dosing, SPECT/CT and whole body planar 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)
Trial Locations
- Locations (45)
MUHC
🇨🇦Montréal, Quebec, Canada
Louisiana State University Health Science Center
🇺🇸Shreveport, Louisiana, United States
Weill Cornell Medical College
🇺🇸New York, New York, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Prostate Cancer Centre
🇨🇦Calgary, AB, Alberta, Canada
Johns Hopkins University
🇺🇸Baltimore, Maryland, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Sunnybrook Health Sciences Centre
🇨🇦Toronto, Ontario, Canada
Princess Margaret Cancer Centre
🇨🇦Toronto, Ontario, Canada
Centre d'imagerie moléculaire de Sherbrooke
🇨🇦Sherbrooke, Quebec, Canada
Fox Chase Cancer Center
🇺🇸Rockledge, Pennsylvania, United States
Cancer Care Nova Scotia
🇨🇦Halifax, Nova Scotia, Canada
Jewish General Hospital
🇨🇦Montréal, Quebec, Canada
University of Wisconsin
🇺🇸Madison, Wisconsin, United States
Lions Gate Hospital
🇨🇦North Vancouver, British Columbia, Canada
Centre hospitalier de l'Université de Montréal (CHUM)
🇨🇦Montréal, Quebec, Canada
Hôtel-Dieu de Québec
🇨🇦Québec, Canada
Ottawa Hospital Research Institute, University of Ottawa
🇨🇦Ottawa, Ontario, Canada
Virginia Mason Medical Center
🇺🇸Seattle, Washington, United States
University of Washington School of Medicine
🇺🇸Seattle, Washington, United States
Cancer Care Manitoba
🇨🇦Winnipeg, Manitoba, Canada
University of Minnesota
🇺🇸Minneapolis, Minnesota, United States
University of California San Francisco
🇺🇸San Francisco, California, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
City of Hope Cancer Center
🇺🇸Duarte, California, United States
University of California, Los Angeles
🇺🇸Los Angeles, California, United States
VA Greater Los Angeles Healthcare
🇺🇸Los Angeles, California, United States
University of Colorado Cancer Center
🇺🇸Aurora, Colorado, United States
Yale Cancer Center
🇺🇸New Haven, Connecticut, United States
Florida Urology Partners - Tampa Bay
🇺🇸Clearwater, Florida, United States
Morton Plant Hospital
🇺🇸Clearwater, Florida, United States
University of Georgia / Regents Medical Center
🇺🇸Augusta, Georgia, United States
University of Chicago
🇺🇸Chicago, Illinois, United States
Lahey Clinic
🇺🇸Burlington, Massachusetts, United States
Montgomery General Hospital
🇺🇸Olney, Maryland, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
Washington University
🇺🇸Saint Louis, Missouri, United States
Cooper Health System
🇺🇸Camden, New Jersey, United States
Stony Brook University Medical Center
🇺🇸Stony Brook, New York, United States
Northeast Urology Research
🇺🇸Concord, North Carolina, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Urologic Consultants of Southeastern PA, LLP
🇺🇸Bala-Cynwyd, Pennsylvania, United States
University of Oklahoma Peggy and Charles Stephenson Cancer Center
🇺🇸Oklahoma City, Oklahoma, United States
Thomas Jefferson University
🇺🇸Philadelphia, Pennsylvania, United States