Prostate CancerPROFLuNCT06460454
PROnostic Interest of 18F-FDG PET/CT in Patients With Metastatic Castration-resistant Prostate Cancer (mCPRC) Progressing
An observational study of Prostate Cancer, run by Central Hospital, Nancy, France at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- PET scan of 18F-FDG
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 1 Nov 2024to 25 Feb 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Patients who did not give their consent to use their data retrospectively
Trial locations and contacts
1 site in 1 country.
France1 site
Nuclear medicine Department CHRU de NANCY
Vandœuvre-lès-Nancy, 54511
About this study
Official 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)
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.
Read the 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
- Prostate Cancer
- Being tested
- PET scan of 18F-FDG
- Keywords
- nuclear medicine, prostate cancer, PET scan
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET scan of 18F-FDGDevice
VEREOS PET scanner. Philips VEREOS digital PET-CT scanners are installed in the nuclear medicine department.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: PET scan of 18F-FDG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy of 18FDG PET metabolic volume
Diagnostic accuracy of 18FDG PET metabolic volume in predicting 1-year overall survival.
Measured: 1 year
Secondary outcomes (3)
Diagnostic accuracy of 18FDG PET tumor parameter (SUVmax)
Diagnostic accuracy of 18FDG PET tumor parameter (SUVmax) in predicting 1-year overall survival.
Measured: 1 year
Diagnostic accuracy of 18FDG PET tumor parameters (SUVmean)
Diagnostic accuracy of 18FDG PET tumor parameters (SUVmean), in predicting 1-year overall survival.
Measured: 1 year
Diagnostic accuracy of 18FDG PET tumor parameters (FDG/PSMA mismatch)
Diagnostic accuracy of 18FDG PET tumor parameters (FDG/PSMA mismatch) in predicting 1-year overall survival.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2024
- Study start1 Nov 2024
- Primary completion1 Jan 2025
- Study completion25 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, BOURSIER Caroline, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06460454
- Sponsor's protocol ID
- 2024PI101
- Acronym
- PROFLu
- Status last verified
- Feb 2025
- First submitted
- 11 Jun 2024
- Last updated
- 4 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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)
- ClinicalTrials.gov ID
- NCT06460454
- Acronym / sponsor ID
- PROFLu / 2024PI101
- Conditions
- Prostate Cancer
- Keywords
- nuclear medicine, prostate cancer, PET scan
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 1 Jan 2025 (actual)
- Study completion
- 25 Feb 2025 (actual)
- First posted
- 14 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients treated with 177Lu-PSMA for castration-resistant prostate cancer | – | Device: PET scan of 18F-FDGPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Patients who did not give their consent to use their data retrospectively
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PET scan of 18F-FDGVEREOS PET scanner. Philips VEREOS digital PET-CT scanners are installed in the nuclear medicine department. | Device | Patients treated with 177Lu-PSMA for castration-resistant prostate cancer |
Primary outcome
Diagnostic accuracy of 18FDG PET metabolic volume
Time frame: 1 year
Diagnostic accuracy of 18FDG PET metabolic volume in predicting 1-year overall survival.
3 secondary outcomes
Diagnostic accuracy of 18FDG PET tumor parameter (SUVmax)
Time frame: 1 year
Diagnostic accuracy of 18FDG PET tumor parameters (SUVmean)
Time frame: 1 year
Diagnostic accuracy of 18FDG PET tumor parameters (FDG/PSMA mismatch)
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by Central Hospital, Nancy, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy of 18FDG PET metabolic volume (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2025.