Evaluating 99mTc-MIP-1404 SPECTCT Imaging for Initial Staging in Men with High-Risk Prostate Cancer Compared to Standard Scans

What this Trial Is About

Prostate cancer is the most common cancer among men in Finland, with up to 20% of cases being metastatic at diagnosis and causing significant mortality. Accurate initial staging is crucial for deciding the best treatment approach. Current recommended imaging methods like bone scintigraphy and whole body CT have low sensitivity for detecting metastasis. This trial evaluates a new imaging agent, 99mTc-MIP-1404, used in SPECTCT scans, which binds to the PSMA molecule found on prostate cancer cells and may improve detection accuracy. Participants are randomly assigned to one of two groups for comparison. The control group undergoes traditional imaging with bone scintigraphy and whole body CT. The experimental group receives these standard scans plus additional imaging using 99mTc-MIP-1404 SPECTCT and 18F-PSMA-1007 PETCT. The 99mTc-MIP-1404 is administered as a single intravenous dose. The study aims to determine if this new imaging method is superior in identifying local lymph node metastases and overall metastasis in men with high-risk prostate cancer. During the study, researchers assess the presence of metastases using various imaging techniques and compare their diagnostic accuracy. They evaluate true and false positive and negative rates, inter-rater agreement, and how imaging results influence treatment decisions. Participants are monitored at baseline, and their involvement includes multiple imaging sessions. The trial helps clarify if 99mTc-MIP-1404 SPECTCT can enhance prostate cancer staging and guide better treatment planning.

99mTc-MIP-1404 SPECT/CT in Primary Staging of Prostate Cancer