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

NCT04857502 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-03-13

No results posted yet for this study

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.

Conditions

  • Prostate Carcinoma
  • Recurrent Prostate Carcinoma

Interventions

DRUG

99mTc-based PSMA Imaging and Surgery Agent

Given via IV injection

PROCEDURE

Computed Tomography

Undergo SPECT/CT

PROCEDURE

Single Photon Emission Computed Tomography

Undergo SPECT/CT

Sponsors & Collaborators

  • Jonsson Comprehensive Cancer Center

    lead OTHER

Principal Investigators

  • Jeremie Calais, MD · UCLA / Jonsson Comprehensive Cancer Center

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-27
Primary Completion
2026-06-01
Completion
2027-06-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04857502 on ClinicalTrials.gov