Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06460454
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-14
First Post:
2024-06-11
Brief Title:
PROnostic Interest of 18F-FDG PETCT in Patients With Metastatic Castration-resistant Prostate Cancer mCPRC Progressing
Sponsor:
Central Hospital Nancy France
Organization:
Central Hospital Nancy France
Study Overview
Official Title:
PROnostic Interest of 18F-FDG PETCT in Patients With Metastatic Castration-resistant Prostate Cancer mCPRC Progressing on Chemotherapy Treated With 177 Lu-PSMA PROFLuD7 1 Day
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PROFLu
Brief Summary:
The aim of this retrospective study was to assess the prognostic value of parameters extracted from 18FDG PETCT 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 Administrations FDA and the European Medicines Agencys 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 PETCT to assess PSMA expression by cancer cells but 18FDG PETCT 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 PETCT 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 PETCT and 68Ga-PSMA PET in the initial work-up and follow-up of patients treated with 177Lu-PSMA in mCRPC
Patients eligible for treatment benefit from pre-therapy 68Ga-PSMA positron emission tomography PETCT to assess PSMA expression by cancer cells but 18FDG PETCT 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 PETCT 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 PETCT and 68Ga-PSMA PET in the initial work-up and follow-up of patients treated with 177Lu-PSMA in mCRPC
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None