PSMA-targeted fluorescent dye OTL78 to guide prostate cancer surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This open-label study evaluates the imaging agent OTL78, a PSMA-targeted fluorescent dye, to visualize cancer tissue during robotic prostatectomy with pelvic lymph node dissection. Participants receive 0.06 mg/kg zopocianine (OTL78) 1–7 days before surgery to aid real-time identification of tumor tissue beyond the prostate capsule. The goal is to confirm dose and timing from prior Phase 2 work and support progression to Phase 3. The trial seeks to improve tumor delineation and lymph node visualization to reduce residual disease. Up to 45 adult men with biopsy-proven prostate cancer are enrolled at participating sites in Indiana.

Why it matters

Who can join: the full rules

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.

Where it's running

• Indiana University Health North Hospital
  Carmel, Indiana, United States Recruiting
• Indiana University School of Medicine
  Indianapolis, Indiana, United States Recruiting

Study contacts

• Principal investigator: Clint Bahler, MD — Indiana University
• Study coordinator: Brandon Garver
• Email: brwgarve@iu.edu
• Phone: 317-278-4766

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Using PSMA PET with MRI to watch for prostate cancer returning after focal therapy

  We will try adding a PSMA PET scan to routine MRI follow-up to see if it finds prostate cancer coming back sooner in men who had focal (partial gland) therapy.

  Recruiting University of Chicago · Chicago, Illinois · NCT07115914

• Mini-tumors to guide treatment for aggressive prostate cancer

  We will grow tiny, patient-derived mini-tumors in the lab to test which treatments work best for men with aggressive or metastatic prostate cancer.

  Recruiting Maastricht Radiation Oncology · Heerlen, Limburg and 2 other locations · NCT07004582

• Combining radiotherapy or surgery with intense hormone therapy for advanced prostate cancer

  This study is testing if combining surgery or radiation with strong hormone therapy can help men with newly diagnosed advanced prostate cancer feel better and live longer.

  Recruiting Phase 2 The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · Nanjing, Jiangsu · NCT06992232

• SRT for bone and lymph node metastases in advanced prostate cancer

  This trial tests whether treating multiple metastatic lesions with stereotactic radiotherapy can prolong pain control and prevent complications in men with advanced, treatment‑refractory prostate cancer.

  Recruiting Institut Cancerologie de l'Ouest · Saint-Herblain · NCT06978296

• Fezolinetant to reduce hot flashes in men on androgen-deprivation therapy

  This trial will test whether taking fezolinetant once daily for 4 weeks reduces how often and how severe hot flashes are in men with prostate cancer who are on androgen-deprivation therapy.

  Recruiting Phase 2 Brigham and Women's Hospital · Boston, Massachusetts · NCT06957691

• Robotic Prostatectomy Pain Reduction with Two Insufflation Devices

  This trial tests whether two different pneumoperitoneum devices used during robotic prostatectomy affect pain after surgery in men with prostate cancer.

  Recruiting East and North Hertfordshire NHS Trust · Stevenage, Hertfordshire · NCT06915909

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.