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

Last updated: November 26, 2024
Sponsor: VA Greater Los Angeles Healthcare System
Overall Status: Active - Recruiting

Phase

4

Condition

Neoplasms

Prostate Cancer

Prostate Cancer, Early, Recurrent

Treatment

18F-Fluciclovine PET/CT Scan

Clinical Study ID

NCT06706921
1819674
  • Ages > 18
  • Male

Study 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)-pentanedioi c 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 Criteria

Inclusion

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

Exclusion Criteria:

  • Less than 18 years-old at the time of radiopharmaceutical administration.

  • Medical condition, serious concurrent illness, or other extenuating circumstancethat, in the opinion of the Investigator, may significantly interfere with studyprocedures or compliance.

  • Contraindications to LuPSMA RLT.

Study Design

Total Participants: 15
Treatment Group(s): 1
Primary Treatment: 18F-Fluciclovine PET/CT Scan
Phase: 4
Study Start date:
December 15, 2024
Estimated Completion Date:
November 01, 2027

Study 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.

Connect with a study center

  • VA Greater Los Angeles Healthcare System

    Los Angeles, California 90073
    United States

    Active - Recruiting

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