RecruitingPhase 4NCT06706921

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

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

Sponsor

VA Greater Los Angeles Healthcare System

Enrollment

15 participants

Start Date

Dec 15, 2024

Study Type

INTERVENTIONAL

Conditions

Neoplasms Metastatic Prostate Cancer Neoplasms by Site Prostatic Neoplasms, Castration-Resistant Urogenital Neoplasms Prostatic Neoplasms Prostatic Diseases Genital Neoplasms, Male Male Urogenital Diseases Genital Diseases, Male Urogenital Diseases, Male

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

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating whether a specific type of PET/CT scan (using a tracer called 18F-Fluciclovine) can predict how well patients with advanced prostate cancer will respond to a radioactive treatment called Lutetium-PSMA therapy (Lu-PSMA). **You may be eligible if...** - You have metastatic castration-resistant prostate cancer (cancer that has spread and no longer responds to hormone therapy) - You are already scheduled to receive Lutetium-PSMA (Lu-PSMA) radioligand therapy - You are willing and able to undergo multiple PET/CT scans before and after treatment **You may NOT be eligible if...** - You are under 18 years old - You have a medical condition that would interfere with the scans or study procedures - You have a contraindication to Lu-PSMA therapy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUG18F-Fluciclovine PET/CT Scan

In this prospective study, an 18F-Fluciclovine PET/CT will be additionally obtained at baseline (pre-LuPSMA RLT), and after the 2nd, 4th, 6th LuPSMA RLT cycles.18F-Fluciclovine PET/CT will be acquired within 7 days from the PSMA PET.