Study to Evaluate 99mTc-MIP-1404 SPECT/CT Imaging in Men With Biopsy Proven Low-Grade Prostate Cancer
(proSPECT-AS Trial)
Recruiting in Palo Alto (17 mi)
+44 other locations
Age: 18+
Sex: Male
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Waitlist Available
Sponsor: Molecular Insight Pharmaceuticals, Inc.
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
What is the purpose of this trial?
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.
Eligibility Criteria
Inclusion Criteria
Ability to provide informed consent and willingness to comply with protocol requirements
Life expectancy ≥ 6 months
A diagnostic trans-rectal ultrasound (TRUS)-guided biopsy within 12 months of enrollment showing adenocarcinoma of the prostate gland
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Treatment Details
Interventions
- 99mTc-MIP-1404 Injection (Radioactive Diagnostic Imaging Agent)
Participant Groups
1Treatment groups
Experimental Treatment
Group I: 99mTc-MIP-1404 InjectionExperimental Treatment2 Interventions
20 ± 3 millicurie (mCi) intravenous (IV) injection of 99mTc-MIP-1404
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Weill Cornell Medical CollegeNew York, NY
Stony Brook University Medical CenterStony Brook, NY
Northeast Urology ResearchConcord, NC
University of Oklahoma Peggy and Charles Stephenson Cancer CenterOklahoma City, OK
More Trial Locations
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Who Is Running the Clinical Trial?
Molecular Insight Pharmaceuticals, Inc.Lead Sponsor