NCT07725523 Safety and Efficacy of OTL78
| NCT ID | NCT07725523 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Clinton Bahler |
| Condition | Prostate Cancer Surgery |
| Study Type | INTERVENTIONAL |
| Enrollment | 45 participants |
| Start Date | 2026-12 |
| Primary Completion | 2027-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 45 participants in total. It began in 2026-12 with a primary completion date of 2027-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a trial to assess the accuracy of an imaging agent, PSMA targeted fluorescent dye OTL78 (zopocianine), in combination with Near InfraRed (NIR) fluorescent imaging, to improve the detection of malignant (growing in an uncontrolled way) tissue in adult patients undergoing standard of care prostatectomy and lymph node dissection for biopsy confirmed prostate cancer. This trial is intended to confirm results from previous Phase 2 dose finding studies and to support the dose selection for subsequent Phase 3 development.
Eligibility Criteria
Inclusion Criteria: 1. Provision of signed and dated informed consent and HIPAA form 2. Male participants 18 years of age and older 3. Known primary prostate cancer and any one of the following: 1. Grade group 3-5; 2. Suspected extra-prostatic extension (EPE) or seminal vesicle invasion (SVI); 3. Suspected lymph node metastasis (clinical stage cN1) by magnetic resonance imaging or by Prostate Specific Membrane Antigen positron emission tomography 4. Planned to undergo a standard of care robotic prostatectomy and lymph node dissection 5. Ability to understand the requirements of the study and agree to abide by the study restrictions and to return for the required assessments 6. 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. 7. Participant scheduled to have or has had a PSMA-PET Scan for surgical treatment planning within 12 months of surgery. Exclusion Criteria: 1. The surgeon plans to perform an extraperitoneal approach 2. History of anaphylactic reactions to products containing indocyanine green 3. History of allergy to any of the components of ZOPOCIANINE: 1. 2-\[3-(1,3-dicarboxypropyl)ureido\] pentanedioic acid (DUPA) 2. Polyethylene glycol-dipeptide linker 3. Chlorodye 4. Impaired renal or hepatic function: 1. Renal: creatinine clearance (eGFR) \< 50 mL/min 2. Hepatic: total bilirubin \> 2 × upper limit of normal or ALT/AST \> 3 × upper limit of normal. 5. Participant with QTc interval ≥ 470 msec per electrocardiogram (ECG) at screening calculated via the Bazett formula. 6. Significant acute or chronic medical, neurologic, or illness in the participant that, in the judgment of the Principal Investigator, could compromise participant safety, limit the ability to complete the study, and/or compromise the objectives of the study.
Contact & Investigator
Clint Bahler, MD
PRINCIPAL INVESTIGATOR
Indiana University
Frequently Asked Questions
Who can join the NCT07725523 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Prostate Cancer Surgery. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07725523 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07725523 currently recruiting?
Yes, NCT07725523 is actively recruiting participants. Contact the research team at brwgarve@iu.edu for enrollment information.
Where is the NCT07725523 trial being conducted?
This trial is being conducted at Carmel, United States, Indianapolis, United States.
Who is sponsoring the NCT07725523 clinical trial?
NCT07725523 is sponsored by Clinton Bahler. The principal investigator is Clint Bahler, MD at Indiana University. The trial plans to enroll 45 participants.
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