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99mTc-PSMA-I&S Biodistribution in Patients With Prostate Cancer

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

Who can join

All ages · Men

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

About the study

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.

What is being tested

• 99mTc-based PSMA Imaging and Surgery Agent (drug)
• Computed Tomography (procedure)
• Single Photon Emission Computed Tomography (procedure)

Sponsor: Jonsson Comprehensive Cancer Center · Participants: 30 · Started: Apr 27, 2021

Contact the study team

• Deepu Varughese · Phone: 310-206-7372
• Ankush Sachdeva · Phone: 310-794-3421

Official record on ClinicalTrials.gov — NCT04857502

Locations in the U.S.

Conditions

• Prostate Cancer

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.