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AzTrials

Prostate Cancer SurgeryPhase 2NCT06849544

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

A Phase 2 study testing 0.03mg/kg ZOPOCIANINE given day of surgery, 0.06mg/kg ZOPOCIANINE given day of surgery and 0.03mg/kg ZOPOCIANINE given day prior to surgery in people with Prostate Cancer Surgery and Prostate Cancer Metastatic Disease, run by Clinton Bahler at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
0.03mg/kg ZOPOCIANINE given day of surgery, 0.06mg/kg ZOPOCIANINE given day of surgery and 0.03mg/kg ZOPOCIANINE given day prior to surgery
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
3 sitesUnited States
Study dates
2 Apr 2025to 6 Aug 2026
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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+));
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  • 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.

Who cannot join

  • The surgeon plans to perform an extraperitoneal approach
  • History of anaphylactic reactions to products containing indocyanine green
  • History of allergy to any of the components of ZOPOCIANINE:
  • 2-[3-(1,3-dicarboxypropyl)ureido] pentanedioic acid (DUPA)
  • Polyethylene glycol-dipeptide linker
  • Chlorodye
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  • Impaired renal or hepatic function:
  • Renal: creatinine clearance (eGFR) < 50 mL/min
  • Hepatic: total bilirubin > 2 × upper limit of normal or ALT/AST > 3 × upper limit of normal.
  • Patients with QTc interval ≥ 470 msec per electrocardiogram (ECG) at screening.
  • Significant acute or chronic medical, neurologic, or illness in the subject that, in the judgment of the Principal Investigator, could compromise subject safety, limit the ability to complete the study, and/or compromise the objectives of the study

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Indiana University Health North Hospital

    Carmel, Indiana, 46032

  • Indiana University Health Methodist Hospital

    Indianapolis, Indiana, 46202

  • Indiana University School of Medicine

    Indianapolis, Indiana, 46202

Other trials in United States

About this study

Official title: 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

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.

Read the detailed description

Prostate cancer (PCa) is the second leading cause of cancer-related death behind lung cancer. Prostate cells express Prostate Specific Membrane Antigen (PSMA), which is overexpressed in PCa cells in over 90% of patients. 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 tissue and lymph nodes. Intra-operative identification of cancer tissue using real-time imaging modalities that could improve tumor identification, demarcation and lymph node involvement may provide a very useful tool to reduce the frequency of residual cancer and increase complete removal of locally involved lymph nodes. This study is an open label trial of an imaging agent, PSMA targeted fluorescent dye (zopocianine, OTL78), in up to 20 subjects with biopsy confirmed PCa who have been scheduled to undergo a laparoscopic radical prostatectomy with pelvic lymph node dissection in order to explore the relationship between the amount of drug given, the timing of administration relative to surgery, and the utility of the drug in visualizing cancerous tissue during a standard of care radical prostatectomy.

Being tested
0.03mg/kg ZOPOCIANINE given day of surgery, 0.06mg/kg ZOPOCIANINE given day of surgery, 0.03mg/kg ZOPOCIANINE given day prior to surgery, 0.06mg/kg ZOPOCIANINE given days prior to surgery
Keywords
Prostate Specific Membrane Antigen, Fluorescent Imaging, Near infrared imaging

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 0.03mg/kg ZOPOCIANINE given day of surgeryDrug

    A single dose of 0.03mg/kg ZOPOCIANINE used with NIR fluorescent imaging during prostatectomy and lymph node dissection

  • 0.06mg/kg ZOPOCIANINE given day of surgeryDrug

    A single dose of 0.06mg/kg ZOPOCIANINE used with NIR fluorescent imaging during prostatectomy and lymph node dissection

  • 0.03mg/kg ZOPOCIANINE given day prior to surgeryDrug

    A single dose of 0.03mg/kg ZOPOCIANINE used with NIR fluorescent imaging during prostatectomy and lymph node dissection

  • 0.06mg/kg ZOPOCIANINE given days prior to surgeryDrug

    A single dose of 0.06mg/kg ZOPOCIANINE used with NIR fluorescent imaging during prostatectomy and lymph node dissection

Study groups in NCT06849544
Study groupRoleWhat they receive
0.03mg/kg ZOPOCIANINE given day of surgeryExperimentalA 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.
Receives: Drug: 0.03mg/kg ZOPOCIANINE given day of surgery
0.06mg/kg ZOPOCIANINE given day prior to surgeryExperimentalA 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.
Receives: Drug: 0.06mg/kg ZOPOCIANINE given day of surgery
0.03mg/kg ZOPOCIANINE given day prior to surgeryExperimentalA 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.
Receives: Drug: 0.03mg/kg ZOPOCIANINE given day prior to surgery
0.06mg/kg ZOPOCIANINE given 2-7 days prior to surgeryExperimentalA 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.
Receives: Drug: 0.06mg/kg ZOPOCIANINE given days prior to surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Porportion of subjects who have a Clinically Significant Event

    1. Histologically confirmed cancer in residual non-nodal soft tissue resected solely because of "NIR only" detection as suspicious following prostatectomy.
    2. One or more resected NIR- positive lymph nodes that contain metastatic disease as confirmed by pathology.

    Measured: Day of surgery

Secondary outcomes (4)

  1. Detection of Primary cancer

    For primary cancer, the number of lesions that are either: fluorescence positive, and prostate cancer positive (i.e., true positive); fluorescence positive but cancer negative (i.e., false positive); fluorescence negative but cancer positive (i.e., false negative); or, fluorescence negative and cancer negative (i.e., true negative). We will consider disease state at four (4) defined prostate regions - right posterior, left posterior, anterior, and at the bladder neck

    Measured: Day of surgery

  2. Detection of Metastatic Cancer

    For metastatic cancer spread to lymph nodes, the number of lesions that are either: fluorescence positive, and prostate cancer positive (i.e., true positive); fluorescence positive but cancer negative (i.e., false positive); fluorescence negative but cancer positive (i.e., false negative); or, fluorescence negative and cancer negative (i.e., true negative). We will use six (6) defined lymph node regions (external iliac, internal iliac, common iliac and right and left).

    Measured: Day of surgery

  3. Execution of pre-surgery plan

    The pre-surgery plan will be documented and compared to the documented surgery performed if surgeon reports of changes in scope from initial plan.

    Measured: Day of surgery

  4. Safety and tolerability of ZOPOCIANINE

    Incidence rates of all causally related AEs and all SAEs

    Measured: Screening to 6 week follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Feb 2025
  2. Study start2 Apr 2025
  3. Primary completion15 Jun 2026
  4. Study completion6 Aug 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06849544
Sponsor's protocol ID
UROL-CC-IUSCCC-0902
Status last verified
Aug 2026
First submitted
22 Feb 2025
Last updated
13 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing 0.03mg/kg ZOPOCIANINE given day of surgery, 0.06mg/kg ZOPOCIANINE given day of surgery and 0.03mg/kg ZOPOCIANINE given day prior to surgery in people with Prostate Cancer Surgery and Prostate Cancer Metastatic Disease, run by Clinton Bahler at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Porportion of subjects who have a Clinically Significant Event (time frame: Day of surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06849544.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026.

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