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Fluorescent Tracer OTL78 Shows Potential for Prostate Cancer Detection
According to a first-in-patient study, the prostate-specific membrane antigen (PSMA)-targeted fluorescent tracer OTL78 was well-tolerated and showed potential in improving prostate cancer detection.
In this phase 2a feasibility trial, 18 patients with prostate cancer were enrolled between June 29, 2020, and April 1, 2021. All patients underwent robot-assisted radical prostatectomy using OTL78 along with an extended pelvic lymph node dissection. Patients received a single dose of OTL78 prior to surgery (0.06 mg/kg 1 to 2 hours before surgery; 0.03 mg/kg 1 to 2 hours before surgery; or 0.03 mg/kg 24 hours before surgery). The primary outcomes of the study were safety and pharmacokinetics.
There were 3 serious adverse events (infected lymphocele, urosepsis, and intraperitoneal hemorrhage) observed in 1 patient and all were considered unrelated to the administration of OTL78 or intraoperative fluorescence imaging. There were no instances of patient death, dose reduction, or discontinuation due to drug-related toxicity. The dose-normalized maximum serum concentration was 84.1 ng/mL/mg for the 0.03 mg/kg dose and 79.6 ng/mL/mg for the 0.06 mg/kg dose.
In this trial, study authors concluded, “OTL78 was well-tolerated and had the potential to improve prostate cancer detection.”
They added, “PSMA-directed fluorescence imaging allowed real-time identification of visually occult prostate cancer and might help to achieve complete oncological resections.”
Source:
Stibbe JA, de Barros HA, Linders DGJ, et al. 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. Lancet Oncol. Published online: April 13, 2023. doi:10.1016/S1470-2045(23)00102-X
