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

February 28, 2025 updated by: BOURSIER Caroline, Central Hospital, Nancy, France

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Vandoeuvre les Nancy cedex, France, 54511
        • Nuclear medicine Department CHRU de NANCY

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Patients treated with 177Lu-PSMA for castration-resistant prostate cancer at the CHRU de Nancy and who benefited from 68Ga-PSMA and 18FDG PET scans as part of the initial workup and treatment follow-up.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients treated with 177Lu-PSMA for castration-resistant prostate cancer
Patients treated with 177Lu-PSMA for castration-resistant prostate cancer and who benefited from 68Ga-PSMA and 18FDG PET scans as part of the initial workup and treatment follow-up.
Device: PET scan of 18F-FDG
VEREOS PET scanner. Philips VEREOS digital PET-CT scanners are installed in the nuclear medicine department.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic accuracy of 18FDG PET metabolic volume
Time Frame: 1 year
Diagnostic accuracy of 18FDG PET metabolic volume in predicting 1-year overall survival.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year
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.
1 year
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.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central Hospital, Nancy, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2024

Primary Completion (Actual)

January 1, 2025

Study Completion (Actual)

February 25, 2025

Study Registration Dates

First Submitted

June 11, 2024

First Submitted That Met QC Criteria

June 11, 2024

First Posted (Actual)

June 14, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 28, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024PI101

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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