First-in-patient study of OTL78 for intraoperative fluorescence imaging of prostate-specific membrane antigen-positive prostate cancer: a single-arm, phase 2a, feasibility trial

Prostate-specific membrane antigen-targeted surgery in prostate cancer: Accurate identification, real-time diagnosis, and precise resection

“…The exact resolution of IS-002 is yet to be determined. The sensitivity of ex vivo imaging with OLT78 was higher than its in vivo imaging, because the limited range of motion of a laparoscope and limited range of fluorescence may cause difficulties in the in vivo visualization of the apex of the prostate, which is located in the deep region of pelvis 15 . Compared with the laparoscope, robotic surgery systems may greatly facilitate deep pelvic visualization and can be better integrated into a robot-assisted fluorescence-guided surgery workflow.…”

“…In a single-arm, phase 2a, feasibility trial, Stibbe et al showed that OTL78 was well tolerated and had the potential to achieve complete oncological resection of PSMs and positive LNMs, with the optimal dose of 30 µg/kg at 24 h preoperatively (Figures 4 - 5 ) 15 . Similarly, Nguyen et al conducted a phase 1, single-center, dose-escalation study to evaluate another near-infrared agent, IS-002, in 24 men with high-risk PCa by RP+ePLND 16 .…”

“…(A) The entire prostate is imaged directly after resection ex vivo on the backtable. Increased fluorescence signal is visible at the apex 15 . (B) Subsequent assessment of the resection bed shows residual fluorescence signal (indicated with an arrow) where the apex used to be 15 .…”

“…Increased fluorescence signal is visible at the apex 15 . (B) Subsequent assessment of the resection bed shows residual fluorescence signal (indicated with an arrow) where the apex used to be 15 . (C) A fluorescent, PSMA-expressing positive surgical margin is seen on ex vivo gross macroscopy 15 .…”

“…(B) Subsequent assessment of the resection bed shows residual fluorescence signal (indicated with an arrow) where the apex used to be 15 . (C) A fluorescent, PSMA-expressing positive surgical margin is seen on ex vivo gross macroscopy 15 . (D) White light and sensitive Firefly image of the excised prostate 24 h after IS-002 injection (100 lg/kg) showing a strong, focal fluorescent signal in the primary tumor 16 .…”