RecruitingPhase 4NCT06706921

18F-Fluciclovine PET/CT Impact on Predicting Clinical Outcome of 177Lu-PSMA-617 Therapy in Patients With Prostate Cancer

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


Sponsor

VA Greater Los Angeles Healthcare System

Enrollment

15 participants

Start Date

Dec 15, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Sex: MALEMin Age: 18 Years

Inclusion Criteria3

  • Patients with mCRPC scheduled to undergo LuPSMA RLT.
  • Willingness to undergo multiple serial PET/CT scans pre- and post-LuPSMA RLT.
  • Ability of providing written informed consent.

Exclusion Criteria3

  • Less than 18 years-old at the time of radiopharmaceutical administration.
  • Medical condition, serious concurrent illness, or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study procedures or compliance.
  • Contraindications to LuPSMA RLT.

Interventions

DRUG18F-Fluciclovine PET/CT Scan

In this prospective study, an 18F-Fluciclovine PET/CT will be additionally obtained at baseline (pre-LuPSMA RLT), and after the 2nd, 4th, 6th LuPSMA RLT cycles.18F-Fluciclovine PET/CT will be acquired within 7 days from the PSMA PET.


Locations(1)

VA Greater Los Angeles Healthcare System

Los Angeles, California, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06706921


Related Trials