Clinical trial Recruiting at 1 site Early Phase 1 Interventional Men only

Exploring the use of a new imaging agent in prostate cancer surgery

Official title: 99mTc-PSMA-I&Amp;S in Patients With Prostate Cancer: An Exploratory Biodistribution Study With Histopathology Validation

Run by Jonsson Comprehensive Cancer Center · NCT04857502 · Data updated 2026-11-12

This study is testing a new imaging agent to see if it can help doctors find cancerous lymph nodes during prostate cancer surgery.

More Prostate Carcinoma trials

Quick facts

PhaseEarly Phase 1
Study typeInterventional
SexMen only
Enrollment30 (estimated)
SponsorJonsson Comprehensive Cancer Center
Academic / other
Locations1 site (Los Angeles, California)
StatusRecruiting
StartedApril 27, 2021
Main results expectedJune 1, 2027
Study endsJune 1, 2028
Registry record updatedJuly 17, 2026
Trial IDNCT04857502 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include men with primary or recurrent prostate cancer who have evidence of lymph node-positive disease and are scheduled for pelvic lymph node dissection.

Probably not a fit

Patients who have started any prostate cancer treatment between enrollment and surgery or have technically inaccessible nodal locations may not benefit from this study.

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

What this trial studies

This exploratory study investigates the biodistribution of a radio-guided surgery agent, 99mTc-PSMA-I&S, in patients with prostate cancer undergoing pelvic lymph node dissection. The study aims to determine how well this agent can identify cancerous lymph nodes during surgery by using a gamma probe to detect PSMA-expressing tissues. Patients will receive the agent intravenously and undergo multiple imaging scans to assess its accumulation in both normal and malignant tissues. The study also seeks to establish the optimal timing for surgery after administration of the imaging agent.

Why it matters

Potential benefit: If successful, this approach could enhance the detection of prostate cancer spread to lymph nodes, potentially improving surgical outcomes.

How similar studies have gone: While this approach is innovative, similar studies using PSMA-targeted imaging agents have shown promise in improving surgical outcomes in prostate cancer.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Men with PCa (primary or recurrent disease)
* Men who received a 68Ga-PSMA-11 positron emission tomography (PET)/computed tomography (CT) for staging or restaging
* Men with evidence of lymph nodes (LNs)-positive disease on 68Ga-PSMA-11 PET/CT
* Men who are scheduled for pelvic LN dissection (PLND)
* Men who can provide oral and written informed consent
* Men who can comply with study procedures

Exclusion Criteria:

* Patients who started any PCa treatment between study enrollment and surgery
* Technically inaccessible nodal location

Where it's running

  • UCLA / Jonsson Comprehensive Cancer Center
    Los Angeles, California, United States
    Recruiting

Study contacts

Similar studies

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

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.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.