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

Recruiting now · Early Phase 1

Conditions studied: Prostate Carcinoma, Recurrent Prostate Carcinoma

In brief

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.

Key facts

Study ID

NCT04857502

Run by

Jonsson Comprehensive Cancer Center

People needed

30

Starts

2021-04-27

Expected to finish

2028-06-01

Last updated by the study team

2026-07-17

Who can join

Age: any. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Patients who started any PCa treatment between study enrollment and surgery
• Technically inaccessible nodal location

Where it is running

• UCLA / Jonsson Comprehensive Cancer Center — Los Angeles, California, United States (enrolling)

Full record on ClinicalTrials.gov

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