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.
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
- Conditions the study is for
- Prostate Cancer Surgery, Prostate Cancer Metastatic Disease
- 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
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.
United States2 sites, 2 recruiting
- 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
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 group | Role | What they receive |
|---|---|---|
| 0.06 mg/kg ZOPOCIANINE given 1-7 days prior to surgery | Experimental | A 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.
Proportion of subjects who have a Clinically Significant Event
- 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)
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
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
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
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
Incidence rates AEs and all SAEs
Incidence rates of all causally related AEs and all SAEs
Measured: Screening to 6 week follow-up
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
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
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.
- First posted24 Jul 2026
- Study startDec 2026 (estimated)
- Primary completionJul 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate Cancer SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Clinton Bahler
- Sponsor type
- University, hospital or other
- Collaborators
- On Target Laboratories, LLC, Indiana University
- Responsible party
- Sponsor-investigator, Clinton Bahler, Indiana University
- Investigators
- Clint Bahler, MD, Principal investigator, Indiana University
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