Health Trials

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

ConditionsProstatic NeoplasmsProstatic Neoplasms, Castration-ResistantMetastatic Prostate CancerMale Urogenital DiseasesProstatic DiseasesUrogenital Diseases, MaleGenital Diseases, MaleNeoplasmsNeoplasms by SiteUrogenital NeoplasmsGenital Neoplasms, Male
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexMale
Age18+
SponsorVA Greater Los Angeles Healthcare System

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • 18F-Fluciclovine PET/CT Scan

Treatment groups

15 Participants
are divided into 1 treatment group

Sponsors and collaborators

VA Greater Los Angeles Healthcare System

Lead sponsor

Source ClinicalTrials.gov