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Clinical Trials/NCT06460454
NCT06460454
Completed
Not Applicable

PROnostic Interest of 18F-FDG PET/CT in Patients With Metastatic Castration-resistant Prostate Cancer (mCPRC) Progressing on Chemotherapy, Treated With 177 Lu-PSMA (PROFLu)D7 (± 1 Day)

Central Hospital, Nancy, France1 site in 1 country100 target enrollmentNovember 1, 2024
ConditionsProstate Cancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Prostate Cancer
Sponsor
Central Hospital, Nancy, France
Enrollment
100
Locations
1
Primary Endpoint
Diagnostic accuracy of 18FDG PET metabolic volume
Status
Completed
Last Updated
last year

Overview

Brief Summary

The aim of this retrospective study was to assess the prognostic value of parameters extracted from 18FDG PET/CT and 68Ga-PSMA PET in the initial workup and follow-up of patients treated with 177Lu-PSMA in mCRPC.

Detailed Description

Prostate-specific membrane antigen (PSMA) is expressed in most metastatic castration-resistant prostate cancer (mCRPC) cells. In response to this finding, a vectorized internal radiotherapy (VIR) therapy was developed, lutetium 177-labeled PSMA, 177Lu-PSMA. Clinical trials have demonstrated its efficacy in men with metastatic castration-resistant prostate cancer . The number of patients treated in nuclear medicine departments has increased considerably in recent years, notably with the Food and Drug Administration's (FDA) and the European Medicines Agency's (EMA) approval of this treatment (177Lu-PSMA-617, Pluvicto®) in the setting of progressive mCRPC after at least one line of 2nd-generation hormone therapy and one line of taxane chemotherapy. Patients eligible for treatment benefit from pre-therapy 68Ga-PSMA positron emission tomography (PET/CT) to assess PSMA expression by cancer cells, but 18FDG PET/CT, although mentioned in the EANM guidelines, is not routinely performed. For treatment follow-up of prostate cancer patients, the PCWG3 (prostate cancer working group 3) currently recommends conventional imaging (CT scan and bone scan) (4) and makes no mention of metabolic imaging, even though some lesions are not detectable with conventional imaging. In addition, one study reported that a high metabolic volume 18FDG PET/CT scan as part of the pre-therapy work-up for mCRPC prior to the introduction of 177Lu-PSMA or Cabazitaxel therapy was associated with a poorer response to treatment. The aim of this retrospective study was to assess the prognostic value of parameters extracted from 18FDG PET/CT and 68Ga-PSMA PET in the initial work-up and follow-up of patients treated with 177Lu-PSMA in mCRPC.

Registry
clinicaltrials.gov
Start Date
November 1, 2024
End Date
February 25, 2025
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
Central Hospital, Nancy, France
Responsible Party
Principal Investigator
Principal Investigator

BOURSIER Caroline

Principal Investigator

Central Hospital, Nancy, France

Eligibility Criteria

Inclusion Criteria

  • Patients treated with 177Lu-PSMA for castration-resistant prostate cancer at Nancy University Hospital
  • Patients with 68Ga-PSMA and 18FDG PET scans as part of the initial workup and treatment follow-up

Exclusion Criteria

  • Patients who did not give their consent to use their data retrospectively

Outcomes

Primary Outcomes

Diagnostic accuracy of 18FDG PET metabolic volume

Time Frame: 1 year

Diagnostic accuracy of 18FDG PET metabolic volume in predicting 1-year overall survival.

Secondary Outcomes

  • Diagnostic accuracy of 18FDG PET tumor parameters (SUVmean)(1 year)
  • Diagnostic accuracy of 18FDG PET tumor parameter (SUVmax)(1 year)
  • Diagnostic accuracy of 18FDG PET tumor parameters (FDG/PSMA mismatch)(1 year)

Study Sites (1)

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