Clinical Trials Directory

Trials / Completed

CompletedNCT06460454

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
Phase
Study type
Observational
Enrollment
100 (actual)
Sponsor
Central Hospital, Nancy, France · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers

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.

Conditions

Interventions

TypeNameDescription
DEVICEPET scan of 18F-FDGVEREOS PET scanner. Philips VEREOS digital PET-CT scanners are installed in the nuclear medicine department.

Timeline

Start date
2024-11-01
Primary completion
2025-01-01
Completion
2025-02-25
First posted
2024-06-14
Last updated
2025-03-04

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT06460454. Inclusion in this directory is not an endorsement.