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

RECRUITINGPhase 4Sponsored by VA Greater Los Angeles Healthcare System
Actively Recruiting
PhasePhase 4
SponsorVA Greater Los Angeles Healthcare System
Started2024-12-15
Est. completion2027-11-01
Eligibility
Age18 Years+
SexMALE
Healthy vol.Accepted
Locations1 site
View on ClinicalTrials.gov →

NCT06706921

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

Age: 18 Years+Sex: MALEHealthy volunteers accepted
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.

Conditions12

CancerGenital Diseases, MaleGenital Neoplasms, MaleMale Urogenital DiseasesMetastatic Prostate CancerNeoplasmsNeoplasms by SiteProstatic DiseasesProstatic NeoplasmsProstatic Neoplasms, Castration-Resistant

Locations1 site

VA Greater Los Angeles Healthcare System
Los Angeles, California, 90073
Gholam Berenji, MD310-268-3547gholam.berenji@va.gov

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