This phase I trial tests the safety, side effects, and best dose of a new imaging agent, Illuminare-1, in imaging nerve cells during surgery in patients with prostate cancer. During surgery for prostate cancer, anatomic differences among patients and nerves positioned close to other structures may make it difficult to see exactly where the nerves are located, which may contribute to accidental injury to the nerves. Complications of nerve injuries include temporary or permanent loss of function or sensation. Illuminaire-1 is a fluorescent imaging agent that makes nerve structures fluoresce (light up). Illuminare-1 attaches to cells called myelin cells that surround the nerves. Injecting Illuminare-1 during surgery in patients with prostate cancer may make the myelin around nerves light up, so that the nerves can be seen more easily.
Additional locations may be listed on ClinicalTrials.gov for NCT04983862.
See trial information on ClinicalTrials.gov for a list of participating sites.
PRIMARY OBJECTIVES:
I. To determine the safety of myelin-binding imaging agent (Illuminare-1) after intravenous administration, as measured by clinical evaluation (24 hour [h] post-injection, postoperative day 10 +/- 5 days, postoperative day 30 +/- 5 days, and postoperative day 45 +/- 10 days). (Part 1 - Dose Escalation)
II. To determine the dose that achieves sustained acceptable fluorescence of the obturator nerve using a subjective intensity scale assessed during surgery. (Part 1 - Dose Escalation)
III. To obtain clinical safety assessments of Illuminare-1, after intravenous administration, at specified time points (24 h post-injection, postoperative day 10 +/- 5 days, postoperative day 30 +/- 5 days and postoperative day 45 +/- 10 days). (Part 2 - Expansion Cohort)
SECONDARY OBJECTIVES:
I. To assess the pharmacokinetics of Illuminare-1 at each dose level tested. (Part 1 - Dose Escalation)
II. To continue visual assessment of the obturator nerve using a subjective intensity scale assessed during the course of surgery. (Part 2 - Expansion Cohort)
EXPLORATORY OBJECTIVES
I. For patients in the expansion cohort once the safe and effective dose has been identified, to assess visualization of the neurovascular bundles under blue-light fluorescence, compared with white-light, at multiple time points during standard of care minimally invasive radical prostatectomy. (Part 2 - Expansion Cohort)
II. To correlate the in vivo and/or ex vivo fluorescent signal of any presumed nerve tissue with corresponding histologic evaluation in select patients undergoing a wider surgical resection as part of routine surgery (i.e., patients with higher-stage disease for whom non-nerve-sparing approaches would normally be used). (Part 2 - Expansion Cohort)
OUTLINE: This is a dose-escalation study of myelin-binding imaging agent followed by a dose-expansion study.
Patients receive myelin-binding imaging agent intravenously (IV) over 5 minutes one time approximately 30 minutes before anticipated need for intraoperative nerve visualization during standard of care surgery. Patients also undergo collection of blood samples on trial.
After completion of study treatment, patients are followed up at 30 and 45 days.
Lead OrganizationMemorial Sloan Kettering Cancer Center
Principal InvestigatorTimothy Francis Donahue
