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RecruitingInterventionalPhase 4

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

NCT ID: NCT06706921Sponsor: VA Greater Los Angeles Healthcare SystemLast updated: 2024-11-27

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.

Arms & 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.

Outcome measures

Primary

  • 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.

    Time frame: From enrollment to end of treatment at 34 weeks.

Secondary

  • 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.

    Time frame: From enrollment to end of treatment at 34 weeks

Eligibility criteria

Sex: MaleAge: 18 Years and olderHealthy volunteers: No
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 locations (1)

VA Greater Los Angeles Healthcare System

Los Angeles, California, 90073

Recruiting
Gholam Berenji, MD · Contact
310-268-3547gholam.berenji@va.gov
Janake Wijesuriya, BS · Contact
310-977-5209Janake.Wijesuriya@va.gov
Gholam Berenji, MD · Principal Investigator