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

Official Title

A Phase 3 Study to Evaluate the Safety and Efficacy of 99mTc-MIP-1404 SPECT/CT Imaging to Detect Clinically Significant Prostate Cancer in Men With Biopsy Proven Low-Grade Prostate Cancer Who Are Candidates for Active Surveillance (proSPECT-AS)

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 grade of ≤ 3+4 severity and / or are candidates for active surveillance, but have planned to undergo radical prostatectomy. In these patients, the results may be used to help estimate the risk of a histopathologic Gleason grade of > 3+4. This Phase 3 study is designed to evaluate the specificity and sensitivity of 99mTc-MIP-1404 to detect clinically significant prostate cancer when compared to histopathology.

Trial Description

Primary Outcome:

  • Specificity of 99mTc-MIP-1404 to detect clinically significant prostate cancer when compared to histopathology
  • Sensitivity of 99mTc-MIP-1404 to detect clinically significant prostate cancer when compared to histopathology
Secondary Outcome:
  • Sensitivity of 99mTc-MIP-1404 in prostate segments as compared to histopathology
  • Specificity of 99mTc-MIP-1404 in prostate segments as compared to histopathology
  • Clinical safety of 99mTc-MIP-1404
This is a multi-centre, 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 and /or are candidates for active surveillance, but have planned to undergo voluntary radical prostatectomy (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. Three independent readers blinded to clinical information will report presence or absence of clinically significant prostate cancer disease. Step-sectioned histopathologic assessment of the prostate gland following radical prostatectomy will be used as the truth standard. Subjects will receive a single dose of 99mTc-MIP-1404 Injection (study drug) followed by imaging (i.e., whole body planar and SPECT/CT) within 3-6 hours post injection. In accordance with standard of care procedures, subjects will undergo voluntary RP surgery and histological assessment of specimens 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 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.

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

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