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

NCT06706921 | Recruiting Phase 4 FDA Drug

• 1 other identifier: 1819674
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

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

Keywords

Prostate cancer; PET/CT; Radioligand Therapy; Metastatic Castration-Resistant Prostate Cancer; PSMA PET

Outcome Measures

Primary Outcomes (1)

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

  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.

  From enrollment to end of treatment at 34 weeks.

Secondary Outcomes (1)

• 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

Other Outcomes (1)

• 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

Study Arms (1)

18F-Fluciclovine PET/CT

EXPERIMENTAL

Subjects receive 18F-Fluciclovine PET/CT scans.

Drug: 18F-Fluciclovine PET/CT Scan

Interventions

18F-Fluciclovine PET/CT Scan DRUG

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.

18F-Fluciclovine PET/CT

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• VA Greater Los Angeles Healthcare System: lead

Study Sites (1)

VA Greater Los Angeles Healthcare System

Los Angeles, California, 90073, United States

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms; Prostatic Neoplasms, Castration-Resistant; Male Urogenital Diseases; Prostatic Diseases; Genital Diseases, Male; Neoplasms; Neoplasms by Site; Urogenital Neoplasms; Genital Neoplasms, Male

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications

Central Study Contacts

Gholam Berenji, MD

CONTACT

310-268-3547; Gholam.Berenji@va.gov

Janake Wijesuriya, BS

CONTACT

310-977-5209; Janake.Wijesuriya@va.gov

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician

Study Record Dates

• First Submitted: October 22, 2024
• First Posted: November 27, 2024
• Study Start: December 15, 2024
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: November 27, 2024

Record last verified: 2024-09

Locations

US (1)