Date: 2016-01-07
Type of information: Initiation of the trial
phase: 3
Announcement: initiation of the trial
Company: Progenics Pharmaceuticals (USA - NY)
Product: 99mTc-MIP-1404
Action
mechanism: imaging agent/radiopharmaceutical. 99mTc-MIP-1404 is a targeted small molecule designed to visualize prostate cancer by targeting prostate specific membrane antigen (PSMA).
Disease: prostate cancer
Therapeutic area: Cancer - Oncology - Diagnostic
Country: Canada, USA
Trial
details: 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 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. (NCT02615067)
Latest
news: * On January 7, 2016, Progenics Pharmaceuticals announced that it has begun enrollment in its pivotal Phase 3 clinical trial evaluating 99mTc-MIP-1404, a small molecule being developed as an imaging agent for prostate cancer. This Phase 3 clinical trial is expected to enroll approximately 450 patients with newly diagnosed low-grade prostate cancer who are candidates for active surveillance, but nonetheless are planning to undergo radical prostatectomy. This multi-center, open-label trial will evaluate the sensitivity and specificity of 99mTc-MIP-1404 in correctly identifying whether or not patients have clinically significant prostate cancer (generally, Gleason score >3+4). In this trial, patients will be imaged prior to their scheduled radical prostatectomy. The truth standard in establishing the sensitivity and specificity of 1404 will be the histopathologist's grading of the prostate tissue removed in the prostatectomy, which will be compared to the 1404 image assessments. An interim analysis of the study will be performed after approximately one-third of the subjects have been enrolled to assess futility and evaluate the need for a sample size re-estimation. Professor William J. Ellis M.D., Department of Urology, University of Washington School of Medicine is the lead Investigator for the Phase 3 Study. * On July 7, 2015, Progenics Pharmaceuticals announced details of its planned Phase 3 clinical trial for 99mTc-MIP-1404, a developmental stage small molecule designed to help visualize prostate cancer by targeting prostate specific membrane antigen (PSMA). Following recent End-of-Phase 2 interactions with the FDA, the design and key elements of a Phase 3 clinical trial for 1404 have been finalized. The Phase 3 clinical trial is expected to enroll approximately 450 patients with biopsy-proven low-grade prostate cancer who are candidates for active surveillance but have planned to undergo radical prostatectomy (RP). The multicenter, multi-reader, open-label study will evaluate the specificity and sensitivity of 99mTc-MIP-1404 to identify clinically significant prostate cancer. Histopathology of the tumor tissue will be used as the truth standard. An interim analysis will be performed after approximately one-third of the subjects have been treated and will include an analysis for futility and also evaluate the need for a sample size re-estimation. Progenics expects the Phase 3 trial to commence by the end of this year.
