Prostate Cancer MetastaticPYPETNCT06450548
Dynamic 68Ga-PSMA and 18F-FDG PET/CT Analysis Prior to 177Lu-PSMA
A study testing Parametric acquisition in people with Prostate Cancer Metastatic, run by Centre Henri Becquerel at 1 site in France.
Trial summary
Prostate cancer is a significant health issue, representing 21.8% of male cancer cases in France with over 449,000 new cases in 2018. It's the cause of 10% of cancer deaths in Europe. The PSMA is a target for mCRPC treatment, with therapies like 177Lu-PSMA-617 delivering radiation to cancer cells. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer Metastatic
- What is being tested?
- Parametric acquisition
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 5 Mar 2025to 5 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent.
- Progressive metastatic castration-resistant prostate adenocarcinoma, which has been treated with taxane chemotherapy and at least one anti-androgen hormone therapy.
- Evaluated by 18F-FDG and 68Ga-PSMA PET/CT prior to potential treatment with 177Lu-PSMA.
- Affiliated with or beneficiary of a social protection scheme.
- WHO stage 0 or 1.
Who cannot join
- Patients unable to understand the study for any reason or comply with the trial requirements (due to language barriers, psychological issues, geographical constraints, etc.).
- Patients unable to undergo the examinations and/or maintain a prolonged lying position (due to back pain, etc.).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Centre Henri Becquerel
Rouen, 76000
Pierre Decazes, Md, +3376673059, pierre.decazes@chb.unicancer.fr
About this study
Official title: Dynamic 68Ga-PSMA and 18F-FDG PET/CT Analysis of Metastatic Prostatic Adenocarcinomas Prior to 177Lu-PSMA Treatment
Prostate cancer is a significant health issue, representing 21.8% of male cancer cases in France with over 449,000 new cases in 2018. It's the cause of 10% of cancer deaths in Europe.
The PSMA is a target for mCRPC treatment, with therapies like 177Lu-PSMA-617 delivering radiation to cancer cells. The Vision study showed that 177Lu-PSMA-617, combined with standard care, improved survival rates significantly compared to standard care alone.The French ANSM authorized 177Lu-PSMA-617 for mCRPC under certain conditions. Patients must have histologically confirmed mCRPC, be progressive despite treatment, and have PSMA-positive imaging.
Read more
Imaging assessments include PSMA PET/CT and 18F-FDG PET/CT to identify FDG-positive and PSMA-negative sites, which are associated with a poorer prognosis.
Parametric analysis using dynamic PET could improve lesion characterization, aiding in treatment decisions. This is the focus of the PyPET study.
The main objective focuses on a comparative analysis of data from dynamic parametric analysis (metabolic influx rate Ki, volume of distribution Vd) and static analysis (standard at 1 hour) using 18F-FDG and 68Ga-PSMA PET/CT for diagnosing metastases, especially in the liver, lymph nodes, and bones. It aims to assess the effectiveness of these imaging techniques in accurately identifying metastatic sites.
- Conditions
- Prostate Cancer Metastatic
- Being tested
- Parametric acquisition
- Keywords
- prostate cancer, 68GA-PSMA, parametric acquisition
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parametric acquisitionOther
Parametric acquisition for 18F-FDG PET/CT and 68GA-PSMA PET/CT with 24 h at 15 days of interval
| Study group | Role | What they receive |
|---|---|---|
| Dynamic and static acquisition | Experimental | Dynamic and static PET acquisitions with 18F-FDG and 68Ga-PSMA will be performed with a minimum of 24 hours and a maximum of 15 days between the two Receives: Other: Parametric acquisition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparative analysis of data from dynamic parametric analysis (volume of distribution Vd) and static analysis
Measured: 15 days
Comparative analysis of data from dynamic parametric analysis (metabolic influx rate Ki) and static analysis
Measured: 15 days
Secondary outcomes (1)
compare the number of lesions detected as PSMA positive/negative and FDG positive/negative
Comparison of the number of lesions detected as PSMA positive/negative and FDG positive/negative through factorial analysis versus the visual analysis obtained from dynamic and static images (results from the main objective analysis).
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2024
- Study start5 Mar 2025
- Primary completion5 Mar 2028 (estimated)
- Study completion5 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate Cancer MetastaticStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Henri Becquerel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre Decazes, MD,PhD, Study director, Centre Henri Becquerel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06450548
- Sponsor's protocol ID
- CHB23.04
- Acronym
- PYPET
- Status last verified
- Dec 2025
- First submitted
- 28 May 2024
- Last updated
- 2 Jan 2026
- 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 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamic 68Ga-PSMA and 18F-FDG PET/CT Analysis of Metastatic Prostatic Adenocarcinomas Prior to 177Lu-PSMA Treatment
- ClinicalTrials.gov ID
- NCT06450548
- Acronym / sponsor ID
- PYPET / CHB23.04
- Conditions
- Prostate Cancer Metastatic
- Keywords
- prostate cancer, 68GA-PSMA, parametric acquisition
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Centre Henri BecquerelUniversity, hospital or other
- Study start
- 5 Mar 2025 (actual)
- Primary completion
- 5 Mar 2028 (estimated)
- Study completion
- 5 Mar 2028 (estimated)
- First posted
- 10 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.
Prostate cancer is a significant health issue, representing 21.8% of male cancer cases in France with over 449,000 new cases in 2018. It's the cause of 10% of cancer deaths in Europe.
The PSMA is a target for mCRPC treatment, with therapies like 177Lu-PSMA-617 delivering radiation to cancer cells. The Vision study showed that 177Lu-PSMA-617, combined with standard care, improved survival rates significantly compared to standard care alone.The French ANSM authorized 177Lu-PSMA-617 for mCRPC under certain conditions. Patients must have histologically confirmed mCRPC, be progressive despite treatment, and have PSMA-positive imaging.
Imaging assessments include PSMA PET/CT and 18F-FDG PET/CT to identify FDG-positive and PSMA-negative sites, which are associated with a poorer prognosis.
Parametric analysis using dynamic PET could improve lesion characterization, aiding in treatment decisions. This is the focus of the PyPET study.
The main objective focuses on a comparative analysis of data from dynamic parametric analysis (metabolic influx rate Ki, volume of distribution Vd) and static analysis (standard at 1 hour) using 18F-FDG and 68Ga-PSMA PET/CT for diagnosing metastases, especially in the liver, lymph nodes, and bones. It aims to assess the effectiveness of these imaging techniques in accurately identifying metastatic sites.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dynamic and static acquisition | Experimental | Other: Parametric acquisitionDynamic and static PET acquisitions with 18F-FDG and 68Ga-PSMA will be performed with a minimum of 24 hours and a maximum of 15 days between the two |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Signed informed consent.
- Progressive metastatic castration-resistant prostate adenocarcinoma, which has been treated with taxane chemotherapy and at least one anti-androgen hormone therapy.
- Evaluated by 18F-FDG and 68Ga-PSMA PET/CT prior to potential treatment with 177Lu-PSMA.
- Affiliated with or beneficiary of a social protection scheme.
- WHO stage 0 or 1.
Key exclusion criteria (2 listed)
- Patients unable to understand the study for any reason or comply with the trial requirements (due to language barriers, psychological issues, geographical constraints, etc.).
- Patients unable to undergo the examinations and/or maintain a prolonged lying position (due to back pain, etc.).
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 |
|---|---|---|
| Parametric acquisitionParametric acquisition for 18F-FDG PET/CT and 68GA-PSMA PET/CT with 24 h at 15 days of interval | Other | Dynamic and static acquisition |
Primary outcome
Comparative analysis of data from dynamic parametric analysis (volume of distribution Vd) and static analysis
Time frame: 15 days
Comparative analysis of data from dynamic parametric analysis (metabolic influx rate Ki) and static analysis
Time frame: 15 days
1 secondary outcome
compare the number of lesions detected as PSMA positive/negative and FDG positive/negative
Time frame: 15 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2026.
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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.
Pierre Decazes, MD,PhD study director
Centre Henri Becquerel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parametric acquisition in people with Prostate Cancer Metastatic, run by Centre Henri Becquerel 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 5 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 2 Jan 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pierre Decazes, MD,PhD (+3276673059, pierre.decazes@chb.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparative analysis of data from dynamic parametric analysis (volume of distribution Vd) and static analysis (time frame: 15 days). The study lists 2 primary outcomes in all. 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 2 Jan 2026.