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

Phase 4

Recruiting

• 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
• Interventions: Drug: 18F-Fluciclovine PET/CT Scan

• Registration Number: NCT06706921
• Lead Sponsor: VA Greater Los Angeles Healthcare System

Brief 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.

Study Timeline

• Status Verified: 2024-09
• Study First Submitted: 2024-10-22
• Study First Submitted QC: 2024-11-26
• Last Update Submitted: 2024-11-26
• Study First Posted: 2024-11-27
• Last Update Posted: 2024-11-27
• Study Start: 2024-12-15
• Primary Completion: 2027-11-01
• Study Completion: 2027-11-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 15

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
18F-Fluciclovine PET/CT	18F-Fluciclovine PET/CT Scan	Subjects receive 18F-Fluciclovine PET/CT scans.

Primary Outcome Measures

Name	Time	Method
18F-Fluciclovine PET/CT Impact on Predicting Clinical Outcome of 177Lu-PSMA-617 Therapy in Patients With Prostate Cancer	From enrollment to end of treatment at 34 weeks.	Whole-body and lesion-level SUVmean, SUVmax. SUVmax, or maximum standardized uptake value, is a measurement used in positron emission tomography (PET) scans to quantify how much glucose a tumor is metabolizing.

Secondary Outcome Measures

Name	Time	Method
Usefulness of Tumor Heterogeneity Assessment in Patients 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.	From enrollment to end of treatment at 34 weeks	Tumor volume on FDG, Axumin and DCFPyL PET/CT. Tumor volume is the amount of space a tumor occupies, measured in cubic centimeters (cc).

Trial Locations

Locations (1)

VA Greater Los Angeles Healthcare System; 🇺🇸 Los Angeles, California, United States