Zopocianine for Cancer Detection

Recruiting at 2 trial locations

Overseen By Ashley Frazee, PhD

Age: 18+

Sex: Male

Trial Phase: Phase 2

Sponsor: Clinton Bahler

Disqualifiers: Renal impairment, Hepatic impairment, QTc prolongation, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: Day of surgery

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests how well the new drug Zopocianine (administered as OTL78 Injection) aids doctors in identifying cancerous tissue during prostate cancer surgery. The study employs a special imaging technique to illuminate cancer cells, potentially enhancing visibility for surgeons. It targets men with confirmed prostate cancer undergoing surgery to remove the prostate and some lymph nodes. Participants should have prostate cancer that has spread beyond the prostate or into the lymph nodes. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Zopocianine (OTL78) was well-tolerated in earlier studies. An initial study with patients found that this treatment was safe and could help doctors better detect prostate cancer during surgery. Those trials reported no major side effects, suggesting that the treatment is generally safe. This information should reassure potential participants about its safety when considering joining this trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about Zopocianine because it offers a novel approach to cancer detection during surgery. Unlike traditional methods that rely on visual and tactile cues, Zopocianine uses near-infrared (NIR) fluorescent imaging, potentially enhancing the surgeon's ability to identify cancerous tissues more accurately. This innovative method could lead to more precise surgeries, reducing the risk of leaving behind cancerous cells. Additionally, Zopocianine's varying dosing schedules—ranging from hours to days before surgery—allow flexibility in its application, which might optimize its effectiveness in different clinical scenarios.

What evidence suggests that this trial's treatments could be effective for prostate cancer detection?

Research has shown that Zopocianine (OTL78) used with Near InfraRed (NIR) fluorescent imaging can aid in detecting prostate cancer. One study found that combining OTL78 with NIR imaging helps doctors identify cancerous tissue more easily during surgery. Patients tolerated the treatment well, experiencing no serious side effects. In this trial, participants will receive different doses of Zopocianine, such as 0.03 mg/kg or 0.06 mg/kg, administered at various times before surgery. Early results suggest this method could help surgeons identify and remove cancer more accurately. Overall, Zopocianine aims to improve the success of prostate cancer surgeries by making cancerous areas easier to see. ^{1 2 3 4 6}

Who Is on the Research Team?

Clint Bahler, MD

Principal Investigator

Indiana University

Are You a Good Fit for This Trial?

This trial is for adults with biopsy-confirmed prostate cancer who are scheduled for a prostatectomy and lymph node dissection. Specific eligibility details aren't provided, but typically participants must be in good health aside from their cancer and meet certain criteria set by the study.

Inclusion Criteria

Provision of signed and dated informed consent and HIPAA form

I am a man aged 18 or older.

Agree to use a medically acceptable method of birth control or sexual abstinence for the duration of the study

Exclusion Criteria

History of allergy to specific components of ZOPOCIANINE

Patients with QTc interval ≥ 470 msec per ECG at screening

I do not have any serious health issues that could make the trial unsafe for me.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single dose of ZOPOCIANINE with NIR fluorescent imaging during prostatectomy and lymph node dissection

Day of surgery

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 weeks

What Are the Treatments Tested in This Trial?

Interventions

• OTL78 Injection

Trial Overview The trial tests three different doses of Zopocianine (OTL78) given at varying times around surgery day to see if it helps better detect cancerous tissue when used with NIR fluorescent imaging during prostate removal surgeries.

How Is the Trial Designed?

Group I: 0.06mg/kg ZOPOCIANINE given day prior to surgery Experimental Treatment 1 Intervention

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.

Group II: 0.06mg/kg ZOPOCIANINE given 2-7 days prior to surgery Experimental Treatment 1 Intervention

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.

Group III: 0.03mg/kg ZOPOCIANINE given day prior to surgery Experimental Treatment 1 Intervention

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.

Group IV: 0.03mg/kg ZOPOCIANINE given day of surgery Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Clinton Bahler

Lead Sponsor

Trials

3

Recruited

80+

Indiana University Melvin and Bren Simon Cancer Center

Collaborator

Trials

7

Recruited

700+

On Target Laboratories, LLC

Industry Sponsor

Trials

8

Recruited

470+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06849544

Phase II Trial to Investigate the Safety and Efficacy of Four ... This study is being done to compare how well Zopocianine (OTL78) in combination with Near InfraRed (NIR) fluorescent imaging may improve the detection of ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S147020452300102X

First-in-patient study of OTL78 for intraoperative ... This first-in-patient study showed that OTL78 was well tolerated and had the potential to improve prostate cancer detection. Optimal dosing was 0·03 mg/kg, 24 h ...

3. cancer.iu.edu cancer.iu.edu/patients/clinical-trials/65420

UROL-CC-IUSCCC-0902: Clinical Trial Information Phase II Trial to Investigate the Safety and Efficacy of Four Dosing Regimens of OTL78 Injection (Zopocianine), a Prostate-Specific Membrane Antigen ...

4. trialx.com trialx.com/clinical-trials/listings/296218/phase-ii-trial-to-investigate-the-safety-and-efficacy-of-four-dosing-regimens-of-otl78-injection/

Phase II Trial to Investigate the Safety and Efficacy of Four ... This study is being done to compare how well Zopocianine (OTL78) in combination with Near InfraRed (NIR) fluorescent imaging may improve the ...

5. binasss.sa.cr binasss.sa.cr/may23/38.pdf

First-in-patient study of OTL78 for intraoperative ... Our data show that fluorescence-guided prostatectomy with the PSMA-targeting near-infrared agent OTL78 is safe and feasible and provides.

6. aacrjournals.org aacrjournals.org/clincancerres/article/25/1/177/125543/Evaluation-of-Novel-Prostate-Specific-Membrane

Evaluation of Novel Prostate-Specific Membrane Antigen ... In this paper, we describe the synthesis and characterization, optical properties, preclinical evaluation in cancer cell in culture and in subcutaneous and ...