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.
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)
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.
A diagnostic trans-rectal ultrasound (TRUS)-guided biopsy within 12 months of enrollment showing adenocarcinoma of the prostate gland
Within 90 days of consent, serum PSA ≤ 15.0 ng/mL (ug/L) or ≤ 7.5 ug/L if on 5 α-reductase inhibitors.
Candidates for active surveillance and/or a Gleason score ≤3+4
Scheduled to undergo radical prostatectomy with or without pelvic lymph node dissection (PLND)
Life expectancy ≥ 6 months
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Subjects administered a radioisotope within 5 physical half-lives prior to study drug injection.
Previous treatment with hormonal therapy, surgery (except biopsy), radiation therapy,LHRH analogs, and non-steroidal anti-androgens, for the treatment of prostate cancer or benign prostatic hyperplasia (BPH)
Planned androgen or anti-androgen therapy prior to surgery
Subjects with any medical condition or other circumstances that, in the opinion of the investigator, would significantly interfere with obtaining reliable data,achieving study objectives, or completing the study
Malignancy (not including curatively treated basal or squamous cell carcinoma of the skin) within the previous 5 years. (Ta stage transitional cell carcinoma bladder cancer with negative surveillance cystoscopy within the past 2 years may be included).
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