RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

99mTc-PSMA-I&Amp;S in Patients With Prostate Cancer: An Exploratory Biodistribution Study With Histopathology Validation

Quick Facts

Study Start:2021-04-27
Study Completion:2026-06-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04857502

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Men with PCa (primary or recurrent disease)
  2. * Men who received a 68Ga-PSMA-11 positron emission tomography (PET)/computed tomography (CT) for staging or restaging
  3. * Men with evidence of lymph nodes (LNs)-positive disease on 68Ga-PSMA-11 PET/CT
  4. * Men who are scheduled for pelvic LN dissection (PLND)
  5. * Men who can provide oral and written informed consent
  6. * Men who can comply with study procedures
  1. * Patients who started any PCa treatment between study enrollment and surgery
  2. * Technically inaccessible nodal location

Contacts and Locations

Study Contact

Deepu Varughese
CONTACT
310-206-7372
DVarughese@mednet.ucla.edu
Ankush Sachdeva
CONTACT
310-794-3421
ASachdeva@mednet.ucla.edu

Principal Investigator

Jeremie Calais, MD
PRINCIPAL_INVESTIGATOR
UCLA / Jonsson Comprehensive Cancer Center

Study Locations (Sites)

UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, 90095
United States

Collaborators and Investigators

Sponsor: Jonsson Comprehensive Cancer Center

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-04-27
Study Completion Date2026-06-01

Study Record Updates

Study Start Date2021-04-27
Study Completion Date2026-06-01

Terms related to this study

Additional Relevant MeSH Terms

  • Prostate Carcinoma
  • Recurrent Prostate Carcinoma