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

RecruitingPhase 4

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

Who can join

Ages 18 and older · Men

Full eligibility criteria
Inclusion Criteria:

* 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 Criteria:

* 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.

About the study

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.

What is being tested

Sponsor: VA Greater Los Angeles Healthcare System · Participants: 15 · Started: Dec 15, 2024

Contact the study team

Official record on ClinicalTrials.gov — NCT06706921

Locations in the U.S.

CaliforniaVA Greater Los Angeles Healthcare System, Los Angeles

Conditions

From ClinicalTrials.gov, data retrieved Oct 1, 2026. Each study sets its own eligibility; the study team decides who can join.