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

ConditionsProstatic NeoplasmsProstatic Neoplasms, Castration-ResistantMetastatic Prostate CancerMale Urogenital DiseasesProstatic DiseasesUrogenital Diseases, MaleGenital Diseases, MaleNeoplasmsNeoplasms by SiteUrogenital NeoplasmsGenital Neoplasms, Male
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexMale
Age18+
SponsorVA Greater Los Angeles Healthcare System

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

15 Participants
are divided into 1 treatment group
Group A: 18F-Fluciclovine PET/CTExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
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.

Tumor volume on FDG, Axumin and DCFPyL PET/CT. Tumor volume is the amount of space a tumor occupies, measured in cubic centimeters (cc).

Time frame
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.

Percentage change in Whole-body and lesion-level SUVmean, SUVmax and tumor volume on FDG, Axumin and DCFPyL PET/CT pre- and post LuPSMA therapy. A "percentage change" refers to the calculated percentage difference between a initial value ( pre LuPSMA ) and a later measurement ( post LuPSMA ), essentially showing how much the tumor has grown or shrunk compared to its baseline size.

Time frame
From enrollment to end of treatment at 34 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

VA Greater Los Angeles Healthcare System

Lead sponsor

Source ClinicalTrials.gov
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