Phase II Trial to Investigate the Safety and Efficacy of Four Dosing Regimens of OTL78 Injection

Recruiting Phase 2 Interventional Study
Prostate Cancer Surgery Prostate Cancer Metastatic Disease
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Male
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
22 (estimated)
Sponsor
Clinton Bahler · Other
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About This Trial

This study is being done to compare how well Zopocianine (OTL78) in combination with Near InfraRed (NIR) fluorescent imaging may improve the detection of malignant (growing in an uncontrolled way) tissue in adult subjects undergoing prostatectomy and lymph node dissection for biopsy confirmed prostate cancer.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Provision of signed and dated informed consent and HIPAA form 2. Male subjects 18 years of age and older 3. Known primary prostate cancer and Grade Group 3 to 5 (≥ cT3) or one or more of the following: 1. Suspected extraprostatic disease (EPD) (extracapsular extension (EC…
Contacts

Ashley Frazee, PhD

317-948-9575

amfrazee@iu.edu

CONTACT