99mTc-MIP-1404 Injection for Prostate Cancer (proSPECT-AS Trial)

Phase 3

Waitlist Available

Research Sponsored by Molecular Insight Pharmaceuticals, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 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)

Awards & highlights

No Placebo-Only Group

Pivotal Trial

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.

Eligible Conditions

Prostate Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 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)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~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)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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]

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]

Secondary study objectives

Clinical safety of 99mTc-MIP-1404

Sensitivity of 99mTc-MIP-1404 in prostate segments as compared to histopathology following RP [Cohort A only]

Specificity of 99mTc-MIP-1404 in prostate segments as compared to histopathology following RP [Cohort A only]