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PROnostic Interest of 18F-FDG PET/CT in Patients With Metastatic Castration-resistant Prostate Cancer (mCPRC) Progressing

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)

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06460454
Acronym
PROFLu
Enrollment
100
Registered
2024-06-14
Start date
2024-11-01
Completion date
2025-02-25
Last updated
2025-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

nuclear medicine, prostate cancer, PET scan

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.

Interventions

DEVICEPET scan of 18F-FDG

VEREOS PET scanner. Philips VEREOS digital PET-CT scanners are installed in the nuclear medicine department.

Sponsors

Central Hospital, Nancy, France
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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

Design outcomes

Primary

MeasureTime frameDescription
Diagnostic accuracy of 18FDG PET metabolic volume1 yearDiagnostic accuracy of 18FDG PET metabolic volume in predicting 1-year overall survival.

Secondary

MeasureTime frameDescription
Diagnostic accuracy of 18FDG PET tumor parameter (SUVmax)1 yearDiagnostic accuracy of 18FDG PET tumor parameter (SUVmax) in predicting 1-year overall survival.
Diagnostic accuracy of 18FDG PET tumor parameters (SUVmean)1 yearDiagnostic accuracy of 18FDG PET tumor parameters (SUVmean), in predicting 1-year overall survival.
Diagnostic accuracy of 18FDG PET tumor parameters (FDG/PSMA mismatch)1 yearDiagnostic accuracy of 18FDG PET tumor parameters (FDG/PSMA mismatch) in predicting 1-year overall survival.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026