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RecruitingPhase 2 / Phase 3

Safety and Efficacy of OTL78

Safety and Efficacy of OTL78, a PSMA-targeted Fluorescent Agent, for Intraoperative Imaging of Prostate Cancer: A Phase IIb Trial Randomized Trial

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Male only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Pills

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "On Target has developed a PSMA-targeted agent, the drug product OTL78, that fluoresces under NIR illumination to help with the identification of prostate cancer tissue during resection surgery that has extended beyond the capsule of the prostate into adjacent fossa/surgical bed tissue and lymph nodes before wound closure."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests the safety and effectiveness of Zopocianine (OTL78), a drug used with special light imaging to help surgeons find cancer tissue. It aims to choose the dose and timing for adults with prostate cancer confirmed by a tissue sample who are having surgery to remove the prostate and lymph nodes.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be a man age 18 or older.
  • Sign and date the study consent and health privacy forms.
  • Have prostate cancer with at least one of these: grade group 3–5; suspected spread outside the prostate or into nearby glands that make semen; or suspected spread to lymph nodes on MRI or PSMA-PET scans.
  • Plan to have standard robot-assisted surgery to remove the prostate and lymph nodes.
  • Understand the study rules, agree to follow them, and return for required checks.
  • Use an accepted birth control method or avoid sex through the final visit, 6 weeks after the study drug. Female partners must use hormonal or barrier birth control unless past menopause or not having sex.
  • Do not donate sperm during the study or for 3 months after the study drug.
  • Have had or be scheduled for a PSMA-PET scan, which helps locate prostate cancer, for surgery planning within 12 months of surgery.

Who can't join

  • Your surgeon plans to reach the prostate without entering the main space inside the belly, called an extraperitoneal approach.
  • You have had a severe allergic reaction called anaphylaxis to a product containing indocyanine green.
  • You are allergic to a Zopocianine ingredient: DUPA, polyethylene glycol-dipeptide linker, or chlorodye.
  • Your kidney filtering test, called eGFR, is below 50 mL/min.
  • Your liver tests show bilirubin above twice the upper normal limit, or ALT or AST above 3 times the upper normal limit.
  • Your screening heart tracing, called an ECG, shows a QTc of 470 milliseconds or more. QTc measures part of the heart's electrical recovery time.
  • You have a serious short-term or long-term illness that the study doctor thinks could make the study unsafe, keep you from finishing it, or affect its goals.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (2)

IN