99mTc-PSMA-I&S Biodistribution in Patients With Prostate Cancer
Recruiting · NCT04857502 · Interventional (participants receive a specific treatment) · Lead sponsor: Jonsson Comprehensive Cancer Center
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
This exploratory study conducted under the RDRC program studies the biodistribution of 99mTc-PSMA-I\&S in patients with prostate cancer who undergo pelvic lymph node dissection. Prostate specific membrane antigen (PSMA)-targeted radio-guided surgery uses the preoperative intravenous administration of a PSMA-ligand called PSMA-imaging and surgery (I\&S) labeled with the gamma-emitter radioisotope Technetium-99m (99mTc). Giving 99mTc-PSMA-I\&S may detect PSMA-expressing lymph nodes during surgery using a gamma probe and may help guide doctors to detect prostate cancer that has spread to the lymph nodes.
Who can take part
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 is running
1 location listed across 1 US state.
- UCLA / Jonsson Comprehensive Cancer Center - Los Angeles, California, United States