RECRUITING

18F-Fluciclovine PET/CT Impact on Predicting Clinical Outcome of 177Lu-PSMA-617 Therapy 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 a single-center, prospective, exploratory study. Patients with metastatic castration-resistant prostate cancer (mCRPC) scheduled to undergo Lutetium labelled prostate-specific membrane antigen radioligand therapy (LuPSMA RLT) at the West Los Angeles VA (WLA-VA) will be imaged with a baseline F-18 fluorodeoxyglucose positron emission tomography/computed tomography 18F-FDG PET/CT and a 18F-DCFPyL PET/CT (18F-DCFPyL (2-(3-{1-carboxy-5-\[(6-18F-fluoro-pyridine-3-carbonyl)-amino\]-pentyl}-ureido)-pentanedioic acid)positron emission tomography/computed tomography , as per standard of care in our institution. All patients further undergo eventual follow-up prostate-specific membrane antigen positron emission tomography (PSMA PET) after the 2nd, 4th, and 6th LuPSMA RLT cycle. In this prospective study, an18F-Fluciclovine positron emission tomography/computed tomography ( Axumin PET/CT )will be additionally obtained at baseline (pre-LuPSMA RLT), and after the 2nd, 4th, 6th LuPSMA RLT cycles. Axumin PET/CT will be acquired within 7 days from the PSMA PET. This study is open to Veterans only.

Official Title

Usefulness of Tumor Heterogeneity Assessment in Patients With MCRPC Undergoing Radioligand Therapy With 177LU-PSMA-617 Using Serial 18F-DCFPYL, 18F-FDG and 18F-Fluciclovine PET/CT Predicting Clinical Outcome

Quick Facts

Study Start:2024-12-15
Study Completion:2027-11-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06706921

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:18 Years
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patients with mCRPC scheduled to undergo LuPSMA RLT.
  2. * Willingness to undergo multiple serial PET/CT scans pre- and post-LuPSMA RLT.
  3. * Ability of providing written informed consent.
  1. * Less than 18 years-old at the time of radiopharmaceutical administration.
  2. * Medical condition, serious concurrent illness, or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study procedures or compliance.
  3. * Contraindications to LuPSMA RLT.

Contacts and Locations

Study Contact

Gholam Berenji, MD
CONTACT
310-268-3547
Gholam.Berenji@va.gov
Janake Wijesuriya, BS
CONTACT
310-977-5209
Janake.Wijesuriya@va.gov

Study Locations (Sites)

VA Greater Los Angeles Healthcare System
Los Angeles, California, 90073
United States

Collaborators and Investigators

Sponsor: VA Greater Los Angeles Healthcare System

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 Date2024-12-15
Study Completion Date2027-11-01

Study Record Updates

Study Start Date2024-12-15
Study Completion Date2027-11-01

Terms related to this study

Keywords Provided by Researchers

  • Prostate cancer
  • PET/CT
  • Radioligand Therapy
  • Metastatic Castration-Resistant Prostate Cancer
  • PSMA PET

Additional Relevant MeSH Terms

  • Prostatic Neoplasms
  • Prostatic Neoplasms, Castration-Resistant
  • Metastatic Prostate Cancer
  • Male Urogenital Diseases
  • Prostatic Diseases
  • Urogenital Diseases, Male
  • Genital Diseases, Male
  • Neoplasms
  • Neoplasms by Site
  • Urogenital Neoplasms
  • Genital Neoplasms, Male