Study to Evaluate 99mTc-MIP-1404 SPECT/CT Imaging in Men With Biopsy Proven Low-Grade Prostate Cancer

Phase 3

Completed

Conditions: Prostate Cancer

Interventions: Drug: 99mTc-MIP-1404 Injection
Diagnostic 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

Inclusion Criteria

Not provided

Exclusion Criteria

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): City of Hope Cancer Center
🇺🇸
Duarte, California, United States
VA Greater Los Angeles Healthcare
🇺🇸
Los Angeles, California, United States
University of California, Los Angeles
🇺🇸
Los Angeles, California, United States
University of California San Francisco
🇺🇸
San Francisco, 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
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City of Hope Cancer Center
🇺🇸Duarte, California, United States