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

NCT04857502 | Recruiting Early Phase 1 DMC FDA Drug

• 2 other identifiers: 20-002256NCI-2021-01793
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 from injection to imaging (range: 1-46 hours)

Secondary Outcomes (2)

• 99mTc-PSMA-I&S accumulation within tumor lesions observed by in-vivo SPECT (SUVmean and SUVmax) will be correlated with ex-vivo gamma measurements (counts/minute) and level of PSMA expression quantified by histopathology (IHC score)

  time from injection to imaging (range: 1-46 hours)

• The best time-point for 99mTc-PSMA-I&S radioguided surgery will be determined by the tumor-to-background uptake ratio (TBR) using the time-activity curve function

  time from injection to imaging (range: 1-46 hours)

Study Arms (1)

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

EXPERIMENTAL

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.

Drug: 99mTc-based PSMA Imaging and Surgery Agent; Procedure: Computed Tomography; Procedure: Single Photon Emission Computed Tomography

Interventions

99mTc-based PSMA Imaging and Surgery Agent DRUG

Given via IV injection

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

Computed Tomography PROCEDURE

Undergo SPECT/CT

Also known as: CAT, CAT Scan, Computerized Axial Tomography, Computerized Tomography, CT, CT Scan, tomography

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

Single Photon Emission Computed Tomography PROCEDURE

Undergo SPECT/CT

Also known as: Medical Imaging, Single Photon Emission Computed Tomography, Single Photon Emission Tomography, single-photon emission computed tomography, SPECT, SPECT imaging, SPECT SCAN, SPET, tomography, emission computed, single photon, Tomography, Emission-Computed, Single-Photon

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

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Jonsson Comprehensive Cancer Center: lead

Study Sites (1)

UCLA / Jonsson Comprehensive Cancer Center

Los Angeles, California, 90095, United States

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

X-Rays; Photons

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Radiation; Radiation, Ionizing; Elementary Particles; Light; Optical Phenomena; Radiation, Nonionizing

Study Officials

• Jeremie Calais, MD

  UCLA / Jonsson Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Deepu Varughese

CONTACT

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

Ankush Sachdeva

CONTACT

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

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2021
• First Posted: April 23, 2021
• Study Start: April 27, 2021
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: March 13, 2026

Record last verified: 2026-03

Locations

US (1)