18F-Fluciclovine PET/CT Impact on Predicting Clinical Outcome of 177Lu-PSMA-617 Therapy in Patients With Prostate Cancer
Recruiting now · Phase 4
Conditions studied: 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
In brief
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.
Key facts
- Study ID
- NCT06706921
- Run by
- VA Greater Los Angeles Healthcare System
- People needed
- 15
- Starts
- 2024-12-15
- Expected to finish
- 2027-11-01
- Last updated by the study team
- 2024-11-27
Who can join
Age: 18 and older. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- VA Greater Los Angeles Healthcare System — Los Angeles, California, United States (enrolling)
Full record on ClinicalTrials.gov
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