Recruiting
Early Phase 1

99mTc-PSMA-I&S

Sponsor:

Jonsson Comprehensive Cancer Center

Code:

NCT04857502

Conditions

Prostate Carcinoma

Recurrent Prostate Carcinoma

Eligibility Criteria

Sex: Male

Age: 0+

Healthy Volunteers: Not accepted

Interventions

99mTc-based PSMA Imaging and Surgery Agent

Computed Tomography

Single Photon Emission Computed Tomography

Study Details

Brief 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

Study ID

NCT04857502

Start date

Apr 27, 2021

Status verified date

Mar, 2026

Completion date

Jun 1, 2028

Anticipated

Primary completion date

Jun 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 0+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Diagnostic (99mTc-PSMA-I&S, SPECT/CT)

The first 5 patients receive an initial dose of undergo 99mTc-PSMA-I\&S IV followed by 5 SPECT/CT scans at 3-5, 5-20, 17-21, 25-29, and 40-46 hours later. These 5 patients then receive a second dose of 99mTc-PSMA-I\&S IV and then undergo standard of care surgery. All subsequent patients receive one dose of 99mTc-PSMA-I\&S IV before standard of care surgery.

Interventions

99mTc-based PSMA Imaging and Surgery Agent

Given via IV injection

Computed Tomography

Undergo SPECT/CT

Single Photon Emission Computed Tomography

Undergo SPECT/CT

Primary outcome measure

  • The biodistribution of 99mTc-PSMA-I&S in normal and malignant tissues of patients with prostate cancer will be measured by average and maximum standardized uptake value (SUVmean and SUVmax) [ Time Frame: time from injection to imaging (range: 1-46 hours) ]

Central Contacts and Locations

Central contacts

Deepu Varughese

310-206-7372DVarughese@mednet.ucla.edu

Ankush Sachdeva

310-794-3421ASachdeva@mednet.ucla.edu

Locations

UCLA / Jonsson Comprehensive Cancer Center

Recruiting

Los Angeles, California, United States, 90095

Contacts

Deepu Varughese

310-206-7372DVarughese@mednet.ucla.edu

Ankush Sachdeva

310-794-3421ASachdeva@mednet.ucla.edu

Principal Investigator:

Jeremie Calais, MD

More Information

Sponsor

Jonsson Comprehensive Cancer Center

Last update posted

Jul 17, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Jonsson Comprehensive Cancer Center on 2026-07-17.