Exploring the use of a new imaging agent in prostate cancer surgery
99mTc-PSMA-I&Amp;S in Patients With Prostate Cancer: An Exploratory Biodistribution Study With Histopathology Validation
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 |
| Enrollment | 30 (estimated) |
| Sex | Male |
| Sponsor | Jonsson Comprehensive Cancer Center Academic / other |
| Locations | 1 site (Los Angeles, California) |
| Trial ID | NCT04857502 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: While this approach is innovative, similar studies using PSMA-targeted imaging agents have shown promise in improving surgical outcomes in prostate cancer.
Eligibility criteria
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 this trial is running
Los Angeles, California
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.