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

Clinicaltrials.gov ID: NCT06706921

Status RECRUITING

Phase PHASE4

Age ≥ 18 Years

Enrollments 15

Conditions

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

Drugs

18F-Fluciclovine PET/CT Scan

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.

Detailed Description

The imaging analysis will consist in obtaining quantitative measurements of lesion uptake on the pre- and post-LuPSMA RLT (lesion and whole-body SUVmax, SUVmean and tumor volume) at each time point on all PET/CT scans. PET metrics at the lesion- and whole-body level will be compared among different PET radiopharmaceuticals at the same time point, and changes over time will be assessed.

All patients will be followed-up at our institution and clinical outcome will be correlated to the imaging analysis assessment.

Locations

1 location Found with status Recruiting

Status

RECRUITING

Contact Person

Gholam Berenji, MD
310-268-3547
[email protected]

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.

Study Plan