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Prostate Cancer SurgeryPhase 2/3NCT07725523

Safety and Efficacy of OTL78

A Phase 2/3 study testing 0.06 mg/kg ZOPOCIANINE given 1-7 days prior to surgery in people with Prostate Cancer Surgery and Prostate Cancer Metastatic Disease, run by Clinton Bahler at 2 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
0.06 mg/kg ZOPOCIANINE given 1-7 days prior to surgery
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
2 sitesUnited States
Study dates
Dec 2026to Sep 2027
Phase
Phase 2/3
Are there results?
Not yet: the study is under way

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 participants 18 years of age and older
  • Known primary prostate cancer and any one of the following:
  • Grade group 3-5;
  • Suspected extra-prostatic extension (EPE) or seminal vesicle invasion (SVI);
  • Suspected lymph node metastasis (clinical stage cN1) by magnetic resonance imaging or by Prostate Specific Membrane Antigen positron emission tomography
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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.
  • Participant scheduled to have or has had a PSMA-PET Scan for surgical treatment planning within 12 months of surgery.

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.
  • Participant with QTc interval ≥ 470 msec per electrocardiogram (ECG) at screening calculated via the Bazett formula.
  • 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.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Brandon Garver contact

317-278-4766

brwgarve@iu.edu

United States2 sites, 2 recruiting

  • Indiana University Health North Hospital

    Carmel, Indiana, 46032

    Brandon Garver, 317-278-4766, brwgarve@iu.edu

    Clint Bahler, MD

    Recruiting

  • Indiana University School of Medicine

    Indianapolis, Indiana, 46202

    Brandon Garver, 317-278-4766, brwgarve@iu.edu

    Clint Bahler, MD

    Recruiting

Other trials in United States

About this study

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

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.

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 fossa/surgical bed tissue and lymph nodes before wound closure. 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 45 participants with biopsy confirmed PCa who have been scheduled to undergo a laparoscopic radical prostatectomy with pelvic lymph node dissection in order to confirm the optimal dose and administration-to-surgery interval of the drug in visualizing cancerous tissue during a standard of care radical prostatectomy.

Being tested
0.06 mg/kg ZOPOCIANINE given 1-7 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.

  • 0.06 mg/kg ZOPOCIANINE given 1-7 days prior to surgeryDrug

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

Study groups in NCT07725523
Study groupRoleWhat they receive
0.06 mg/kg ZOPOCIANINE given 1-7 days prior to surgeryExperimentalA single dose of 0.06 mg/kg ZOPOCIANINE (given 1-7 days prior to surgery) used with NIR fluorescent imaging following completion of planned prostatectomy and lymph node dissection for biopsy confirmed prostate cancer.
Receives: Drug: 0.06 mg/kg ZOPOCIANINE given 1-7 days prior to surgery

What is being measured

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

  1. Proportion of subjects who have a Clinically Significant Event

    1. Histologically confirmed cancer in residual non-nodal malignant tissue in the prostate bed/fossa resected solely because of OTL78-guided NIR imaging detection b) One or more resected metastatic lymph nodes as confirmed by pathology.

    Measured: Day of surgery

Secondary outcomes (8)

  1. Proportion of subjects who had converted from a positive margin status to no residual tumor

    Histologically confirmed cancer in residual non-nodal malignant tissue in the prostate bed/fossa resected solely because of post-resection NIR imaging with Zopocianine thereby converting an otherwise positive residual margin status to no residual tumor at the corresponding final fossa/surgical bed margin.

    Measured: Day of surgery

  2. 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). Investigators will consider disease state at four (4) defined prostate regions - right posterior, left posterior, anterior, and at the bladder neck

    Measured: Day of surgery

  3. 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). Investigators will use six (6) defined lymph node regions (external iliac, internal iliac, common iliac and right and left)

    Measured: Day of surgery

  4. 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

  5. Incidence rates AEs and all SAEs

    Incidence rates of all causally related AEs and all SAEs

    Measured: Screening to 6 week follow-up

  6. Change in urinary continence following surgery

    Decrease in baseline scores of The Expanded Prostate Cancer Index Composite (EPIC) Urinary Domain (Likert Scale 0-100, higher scores represent better outcomes).

    Measured: Screening to 12 week follow-up

  7. Change in sexual function following surgery

    Decrease in baseline scores of The International Index of Erectile Function (IIEF-6) (Likert Scale 0-75, higher scores represent better outcomes).

    Measured: Screening to 12 week follow-up

  8. Change in PSA following surgery

    Change in PSA results from pre-operative labs.

    Measured: Screening to 12 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 posted24 Jul 2026
  2. Study startDec 2026 (estimated)
  3. Primary completionJul 2027 (estimated)
  4. Study completionSep 2027 (estimated)

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 2/3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
45 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07725523
Sponsor's protocol ID
UROL-CC-IUSCCC-0965
Status last verified
Oct 2026
First submitted
21 Jul 2026
Last updated
22 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing 0.06 mg/kg ZOPOCIANINE given 1-7 days prior to surgery in people with Prostate Cancer Surgery and Prostate Cancer Metastatic Disease, run by Clinton Bahler at 2 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 10 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: looking for participants now, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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 combined 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.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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

Contact Brandon Garver (317-278-4766, brwgarve@iu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion 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 NCT07725523.

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 22 Oct 2026.

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