Phase II Trial to Investigate the Safety and Efficacy of Four Dosing Regimens of OTL78 Injection (Zopocianine), a Prostate-Specific Membrane Antigen (PSMA)-Targeted Fluorescent Agent, for the Intraoperative Imaging of Prostate Cancer

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:

• Provision of signed and dated informed consent and HIPAA form

• Male subjects 18 years of age and older

• Known primary prostate cancer and Grade Group 3 to 5 (≥ cT3) or one or more of the following:

‣ Suspected extraprostatic disease (EPD) (extracapsular extension (ECE) and/or seminal vesicle infiltration (SVI)),

⁃ 3 or more biopsy cores of grade group 3-5;

⁃ Suspected lymph node metastasis (clinical stage cN1, or by magnetic resonance imaging (mriN+), or by Prostate Specific Membrane Antigen positron emission tomography (PSMA PET+));

• Planned to undergo a standard of care robotic prostatectomy and lymph node dissection

• Ability to understand the requirements of the study and agree to abide by the study restrictions and to return for the required assessments

• Agree to use a medically acceptable method of birth control (e.g., spermicide in conjunction with a barrier such as a condom) or sexual abstinence for the duration of the study, including through final study visit (6 weeks) after the dose of study drug. Sperm donation is prohibited during the study and for 3 months after the dose of study drug. Female partners must use hormonal or barrier contraception unless postmenopausal or abstinent.

Locations
United States
Indiana
Indiana University Health North Hospital
RECRUITING
Carmel
Indiana University Health Methodist Hospital
RECRUITING
Indianapolis
Indiana University School of Medicine
RECRUITING
Indianapolis
Contact Information
Primary
Ashley Frazee, PhD
amfrazee@iu.edu
317-948-9575
Time Frame
Start Date: 2025-04-02
Estimated Completion Date: 2026-01
Participants
Target number of participants: 20
Treatments
Experimental: 0.03mg/kg ZOPOCIANINE given day of surgery
A single dose of 0.03mg/kg ZOPOCIANINE (given 1 - 12 hours prior to surgery) used with NIR fluorescent imaging during prostatectomy and lymph node dissection for biopsy confirmed prostate cancer.
Experimental: 0.06mg/kg ZOPOCIANINE given day prior to surgery
A single dose of 0.06mg/kg ZOPOCIANINE (given 12 - 30 hours prior to surgery) used with NIR fluorescent imaging during prostatectomy and lymph node dissection for biopsy confirmed prostate cancer.
Experimental: 0.03mg/kg ZOPOCIANINE given day prior to surgery
A single dose of 0.03mg/kg ZOPOCIANINE (given 12 - 30 hours prior to surgery) used with NIR fluorescent imaging during prostatectomy and lymph node dissection for biopsy confirmed prostate cancer.
Experimental: 0.06mg/kg ZOPOCIANINE given 2-7 days prior to surgery
A single dose of 0.06mg/kg ZOPOCIANINE (given 2-7 days prior to surgery) used with NIR fluorescent imaging during prostatectomy and lymph node dissection for biopsy confirmed prostate cancer.
Related Therapeutic Areas
Sponsors
Leads: Clinton Bahler
Collaborators: Indiana University Melvin and Bren Simon Cancer Center, On Target Laboratories, LLC

This content was sourced from clinicaltrials.gov