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.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Sex | Men only |
| Enrollment | 30 (estimated) |
| Sponsor | Jonsson Comprehensive Cancer Center Academic / other |
| Locations | 1 site (Los Angeles, California) |
| Status | Recruiting |
| Started | April 27, 2021 |
| Main results expected | June 1, 2027 |
| Study ends | June 1, 2028 |
| Registry record updated | July 17, 2026 |
| Trial ID | NCT04857502 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
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UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, United States Recruiting
Study contacts
- Principal investigator: Jeremie Calais, MD — UCLA / Jonsson Comprehensive Cancer Center
- Study coordinator: Deepu Varughese
- Email: DVarughese@mednet.ucla.edu
- Phone: 310-206-7372
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.