Skip to main content
OpenTrials
Completed

NCT Number: NCT06460454

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Nuclear medicine Department CHRU de NANCY

Vandœuvre-lès-Nancy, 54511, France

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PET scan of 18F-FDG

Device

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

Primary outcomes

  1. 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

  1. Diagnostic accuracy of 18FDG PET tumor parameter (SUVmax)

    Time frame: 1 year

    Diagnostic accuracy of 18FDG PET tumor parameter (SUVmax) in predicting 1-year overall survival.

  2. Diagnostic accuracy of 18FDG PET tumor parameters (SUVmean)

    Time frame: 1 year

    Diagnostic accuracy of 18FDG PET tumor parameters (SUVmean), in predicting 1-year overall survival.

  3. Diagnostic accuracy of 18FDG PET tumor parameters (FDG/PSMA mismatch)

    Time frame: 1 year

    Diagnostic accuracy of 18FDG PET tumor parameters (FDG/PSMA mismatch) in predicting 1-year overall survival.

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Official study title

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)

Acronym: PROFLu

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 14, 2024
Registry last updated
Mar 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.