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

VA Greater Los Angeles Healthcare System

Status and phase

Enrolling

Phase 4

Conditions

Metastatic Prostate Cancer

Neoplasms by Site

Neoplasms

Male Urogenital Diseases

Urogenital Neoplasms

Genital Neoplasms, Male

Prostatic Neoplasms, Castration-Resistant

Prostatic Neoplasms

Prostatic Diseases

Genital Diseases, Male

Urogenital Diseases, Male

Treatments

Drug: 18F-Fluciclovine PET/CT Scan

Study type

Interventional

Funder types

Other U.S. Federal agency

Identifiers

NCT06706921

1819674

Details and patient eligibility

About

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.

Full 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.

Enrollment

15 estimated patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.