99mTc-PSMA-I&S Biodistribution in Patients With Prostate Cancer
NCT04857502
Summary
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.
Eligibility
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
Conditions3
Locations1 site
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NCT04857502