Clinical Trials Logo

Clinical Trial 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.


Clinical Trial Description

PRIMARY OBJECTIVE: I. To define the biodistribution of 99mTc-based PSMA imaging and surgery agent (99mTc-PSMA-I&S) in normal and malignant tissues of patients with prostate cancer (PCa) with histopathology validation, when available. SECONDARY OBJECTIVES: I. To correlate the 99mTc-PSMA-I&S accumulation within tumor lesions observed by in-vivo single-photon emission computed tomography (SPECT), ex-vivo gamma measurements and level of prostate-specific membrane antigen (PSMA) expression quantified by histopathology, when available. II. To define the best time-point for radio-guided surgery (RGS) with the highest tumor-to-background ratio following 99mTc-PSMA-I&S administration. OUTLINE: The first 5 patients receive an initial dose of 99mTc-PSMA-I&S intravenously (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 surgery. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04857502
Study type Interventional
Source Jonsson Comprehensive Cancer Center
Contact Deepu Varughese
Phone 310-206-7372
Email DVarughese@mednet.ucla.edu
Status Recruiting
Phase Early Phase 1
Start date April 27, 2021
Completion date June 1, 2025

See also
  Status Clinical Trial Phase
Active, not recruiting NCT04457232 - Prospective Exploratory Study of FAPi PET/CT in Prostate Cancer With Histopathology Validation Phase 1
Active, not recruiting NCT03661437 - Systemic Light Exposure in Preventing Frailty in Older Patients With Prostate Cancer on Hormonal Therapy Early Phase 1
Completed NCT02337465 - KV-CBCT and Ultrasound Imaging in Guiding Radiation Therapy in Patients With Prostate, Liver, or Pancreatic Cancer N/A
Completed NCT03013413 - Ultrasound-Based Imaging Using the Aixplorer System in Diagnosing Prostate Cancer in Patients Undergoing Biopsy N/A
Recruiting NCT06037863 - Evaluation of the Impact of Empty Versus Full Bladder in Patients With Prostate Cancer, RELIEF Trial N/A
Recruiting NCT03580499 - Vitamin B6 in Reducing Hot Flashes in Participants With Prostate Cancer Undergoing Antiandrogen Therapy N/A
Completed NCT03326440 - Virtual Environment Radiotherapy to Improve Patients' Compliance to Radiotherapy (RT) in Prostate Cancer N/A
Recruiting NCT04597359 - To Evaluate if Green Tea Can be Effective in Reducing the Progression of Prostate Cancer in Men on Close Monitoring Phase 2
Active, not recruiting NCT03263650 - Study of Olaparib Maintenance Following Cabazitaxel-Carbo in Men With AVPC Phase 2
Active, not recruiting NCT04299620 - Micro-Ultrasound for the Detection and Localization of Prostate Cancer Tumors in Patients Undergoing Radical Prostatectomy N/A
Completed NCT04976257 - Pharmacokinetics of IA and IV Ga68-PSMA-11 Infusion Early Phase 1
Completed NCT02957981 - The Genetic Education for Men Trial: Web-Based Education vs. Standard Care N/A
Withdrawn NCT03408561 - Social Media Listening in Improving Clinical Trial Recruitment in Patients With Cancer N/A
Enrolling by invitation NCT04254133 - Genetic Information to Inform Treatment and Screening for Prostate Cancer, GIFTS Study
Recruiting NCT05519878 - Light Therapy and Occupational Therapy Fatigue Management-Based Intervention for Patients With Genitourinary Cancers N/A
Recruiting NCT02994758 - Development of Diagnostics and Treatment of Urological Cancers N/A
Completed NCT01497431 - Se-Methyl-Seleno-L-Cysteine or Selenomethionine in Preventing Prostate Cancer in Healthy Participants Phase 1
Active, not recruiting NCT00002540 - Screening for Prostate Cancer in Older Patients (PLCO Screening Trial) N/A
Completed NCT03101046 - Treatment of Metastatic Castrate Resistant Prostate Cancer Patients According to Circulating Tumor Cells Kinetic Phase 2
Recruiting NCT03485794 - Collection of Blood in Studying Metabolites in Patients With Prostate Cancer