Phase 2 Prostate Cancer Trial, Recruiting NCT06849544 Sponsor: Clinton Bahler Condition: Prostate Cancer
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Phase 2 Prostate Cancer Trial, Recruiting

NCT06849544
Recruiting Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who have signed and dated a consent form and a HIPAA privacy form
  • Men aged 18 years or older
  • People with a confirmed diagnosis of prostate cancer that is Grade Group 3 to 5 (a higher-risk grade) or has spread beyond the prostate, OR has spread into the outer layer of the prostate or nearby seminal vesicles, OR has 3 or more biopsy tissue samples showing higher-grade cancer, OR is suspected to have spread to nearby lymph nodes (based on clinical assessment, MRI, or a special type of scan called a PSMA PET scan)
  • People who are scheduled to have a robotic prostate removal surgery and lymph node removal as part of their standard care
  • People who are able to understand the study requirements and agree to follow the study rules and attend all required appointments
  • People who agree to use an approved method of contraception or abstain from sex for the duration of the study and for 6 weeks after receiving the study drug, and to avoid sperm donation during the study and for 3 months after receiving the study drug (female partners must also use hormonal or barrier contraception unless postmenopausal or abstinent)

Who may not be able to join:

  • People whose surgeon plans to use a specific surgical approach called the extraperitoneal approach
  • People who have previously had a severe allergic (anaphylactic) reaction to products containing indocyanine green (a type of medical dye)
  • People who have a known allergy to any ingredient in the study drug ZOPOCIANINE, including certain chemical components (confirm with trial site for full details)
  • People whose kidneys or liver are not functioning well enough — specifically, those with a kidney filtration rate below 50 mL/min, or certain elevated liver test results above defined thresholds (confirm with trial site)
  • People who have an abnormal heart rhythm measurement (called a QTc interval of 470 milliseconds or more) on a heart tracing test (ECG) done at screening
  • People with a significant ongoing or recent serious medical, neurological, or other health condition that, in the lead doctor's opinion, could affect their safety, their ability to complete the study, or the study's results

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 16 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Clint Bahler, MD, Indiana University

Phone: 317-948-9575

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
Clinton Bahler
Registry
ClinicalTrials.gov
Start date
2 April 2025
Est. completion
1 July 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Porportion of subjects who have a Clinically Significant Event

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 16 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov