Prostate CancerTAYLORNCT06917781
Prostate Cancer Burden and Heterogeneity Evaluation Towards Liquid Biopsy: a Correlation Study to 18FDCFPyL PET and Patients Outcome
A study testing Patients with 18F-PET-PSMA indication in people with Prostate Cancer, run by Institut Claudius Regaud at 1 site in France.
Trial summary
This is a prospective, monocentric, proof of concept study aims to identify in prostate cancer patients, a potential relationship between CTC-PSMA positivity and 18F-PET-PSMA results as well as patient outcome. Patients with 18F-PET-PSMA indication will perform imaging extension work-up as part of current practice. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Patients with 18F-PET-PSMA indication
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- 28 Oct 2025to Oct 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
- Age ≥ 18 years
- Histologically confirmed adenocarcinoma of the prostate
- Indication for 18F-PET-PSMA imaging
- Signed written informed consent
- Patient able to participate and willing to give informed consent prior performance of any study-related procedures and to comply with the study protocol
- Patient affiliated to a Social Health Insurance in France.
Who cannot join
- Patients with a contraindication to 18F-PET-PSMA
- Patient with an established neuro endocrine prostate cancer
- Concurrent malignancy known to express a significant amount of PSMA (renal cancer, salivary gland tumors)
- Any psychological, familial, geographic or social situation, according to the judgment of investigator, potentially preventing the provision of informed consent or compliance to study procedure
- Patient who has forfeited his freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice).
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
IUCT-O
Toulouse
Thibaut CASSOU-MOUNAT, +33 (0)5 31 15 65 49, Cassou-Mounat.Thibaut@iuct-oncopole.fr
About this study
This is a prospective, monocentric, proof of concept study aims to identify in prostate cancer patients, a potential relationship between CTC-PSMA positivity and 18F-PET-PSMA results as well as patient outcome.
Patients with 18F-PET-PSMA indication will perform imaging extension work-up as part of current practice. If they agree to participate in the study, a blood sample will be performed prior to the 18F-PET-PSMA standard imaging (T1).
Read more
In order to evaluate the potential relationship between CTC-PSMA and 18F-PET-PSMA imaging, the study will be presented to all patients seen in consultation for an extension workup for prostate cancer. This will allow to analyze the results in patients with different level of tumor burden afterward to define the following three groups based on imaging results:
Group 1 : no tumor volume Negative 18F-PET-PSMA (patients without uptake lesion)
Group 2 : low or medium tumor volume Positive 18F-PET-PSMA (patients with an uptake in prostate bed or with an oligo-metastatic extension (number of lesions < 6))
Group 3 : high tumor volume Positive 18F-PET-PSMA (patients with a polymetastastatic extension (number of lesions ≥ 6)).
In each of these groups, the rate of patients with positive PSMA CTC will be analyzed (i.e. patient having at least one CTC-PSMA positive).
For patients with an indication of treatment by 177LuPSMA-617 (PLUVICTO®) according to standard practices, additional blood samples will also be collected at the following time points: 2nd cycle (T2) and 4th cycle of treatment (T3), just before injection. For these patients, data will be collected up to 6 months after the last treatment injection (clinical and biological data; results of tumor assessments based on 18F-PET-PSMA imaging).
- Conditions
- Prostate Cancer
- Being tested
- Patients with 18F-PET-PSMA indication
- Keywords
- Prostate Cancer, 18F-PET-PSMA, Circulating Tumor Cells, Liquid biopsy
- Medical subject headings
- Prostatic Neoplasms, Neoplastic Cells, Circulating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients with 18F-PET-PSMA indicationOther
Blood samples taken on several occasions:
- before the 18F-PSMA PET scan for extension assessment, for all patients.
- at 2nd and 4th treatment cycles (prior to treatment administration), only for patients receiving PLUVICTO® therapy.
During the 1st treatment cycle, samples (optional for the patient) may also be taken at 5 different post-perfusion times.
In addition, all imaging examinations performed during the study (standard 18F-PSMA PET scans) will be collected and centralized by the Sponsor for analysis.
| Study group | Role | What they receive |
|---|---|---|
| Patients with prostate cancer | Other | Not described Receives: Other: Patients with 18F-PET-PSMA indication |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of patients presenting at least one (i.e >0) CTC-PSMA positive.
The rate of patients presenting at least one CTC-PSMA positive is defined as the ratio of the number of patients having at least one CTC-PSMA positive divided by the total number of patients evaluable in each group (G1, G2, G3).
Measured: 1 day for each patient
Secondary outcomes (4)
The number of CTC-PSMA positive will be evaluated at inclusion for each group and just before the 2nd and 4th course of 177LuPSMA (C2/C4).
Measured: 18 weeks for each patient
CTC-PSMA change will be defined as the number of CTC-PSMA positive at C2/C4 minus the number of CTC-PSMA positive at inclusion, if feasible.
Measured: 18 weeks for each patient
The total number of CTC will be evaluated.
Measured: 18 weeks for each patient
The response to 177LuPSMA
It will be evaluated according to investigator judgement and PSMA uptake alteration on PET as proposed in PROMISE V2.
Measured: 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2025
- Study start28 Oct 2025
- Primary completionOct 2027 (estimated)
- Study completionOct 2028 (estimated)
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.
- 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
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Claudius Regaud
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06917781
- Sponsor's protocol ID
- 25GENH01
- Acronym
- TAYLOR
- Status last verified
- Nov 2025
- First submitted
- 1 Apr 2025
- Last updated
- 18 Nov 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 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prostate Cancer Burden and Heterogeneity Evaluation Towards Liquid Biopsy: a Correlation Study to 18FDCFPyL PET and Patients Outcome
- ClinicalTrials.gov ID
- NCT06917781
- Acronym / sponsor ID
- TAYLOR / 25GENH01
- Conditions
- Prostate Cancer
- Keywords
- Prostate Cancer, 18F-PET-PSMA, Circulating Tumor Cells, Liquid biopsy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Institut Claudius RegaudUniversity, hospital or other
- Study start
- 28 Oct 2025 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 8 Apr 2025 (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.
This is a prospective, monocentric, proof of concept study aims to identify in prostate cancer patients, a potential relationship between CTC-PSMA positivity and 18F-PET-PSMA results as well as patient outcome.
Patients with 18F-PET-PSMA indication will perform imaging extension work-up as part of current practice. If they agree to participate in the study, a blood sample will be performed prior to the 18F-PET-PSMA standard imaging (T1).
In order to evaluate the potential relationship between CTC-PSMA and 18F-PET-PSMA imaging, the study will be presented to all patients seen in consultation for an extension workup for prostate cancer. This will allow to analyze the results in patients with different level of tumor burden afterward to define the following three groups based on imaging results:
Group 1 : no tumor volume Negative 18F-PET-PSMA (patients without uptake lesion)
Group 2 : low or medium tumor volume Positive 18F-PET-PSMA (patients with an uptake in prostate bed or with an oligo-metastatic extension (number of lesions < 6))
Group 3 : high tumor volume Positive 18F-PET-PSMA (patients with a polymetastastatic extension (number of lesions ≥ 6)).
In each of these groups, the rate of patients with positive PSMA CTC will be analyzed (i.e. patient having at least one CTC-PSMA positive).
For patients with an indication of treatment by 177LuPSMA-617 (PLUVICTO®) according to standard practices, additional blood samples will also be collected at the following time points: 2nd cycle (T2) and 4th cycle of treatment (T3), just before injection. For these patients, data will be collected up to 6 months after the last treatment injection (clinical and biological data; results of tumor assessments based on 18F-PET-PSMA imaging).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with prostate cancer | Other | Other: Patients with 18F-PET-PSMA indication |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 18 years
- Histologically confirmed adenocarcinoma of the prostate
- Indication for 18F-PET-PSMA imaging
- Signed written informed consent
- Patient able to participate and willing to give informed consent prior performance of any study-related procedures and to comply with the study protocol
Key exclusion criteria (5 listed)
- Patients with a contraindication to 18F-PET-PSMA
- Patient with an established neuro endocrine prostate cancer
- Concurrent malignancy known to express a significant amount of PSMA (renal cancer, salivary gland tumors)
- Any psychological, familial, geographic or social situation, according to the judgment of investigator, potentially preventing the provision of informed consent or compliance to study procedure
- Patient who has forfeited his freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice).
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 |
|---|---|---|
| Patients with 18F-PET-PSMA indicationBlood samples taken on several occasions: * before the 18F-PSMA PET scan for extension assessment, for all patients. * at 2nd and 4th treatment cycles (prior to treatment administration), only for patients receiving PLUVICTO® therapy. During the 1st treatment cycle, samples (optional for the patient) may also be taken at 5 different post-perfusion times. In addition, all imaging examinations performed during the study (standard 18F-PSMA PET scans) will be collected and centralized by the Sponsor for analysis. | Other | Patients with prostate cancer |
Primary outcome
The rate of patients presenting at least one (i.e >0) CTC-PSMA positive.
Time frame: 1 day for each patient
The rate of patients presenting at least one CTC-PSMA positive is defined as the ratio of the number of patients having at least one CTC-PSMA positive divided by the total number of patients evaluable in each group (G1, G2, G3).
4 secondary outcomes
The number of CTC-PSMA positive will be evaluated at inclusion for each group and just before the 2nd and 4th course of 177LuPSMA (C2/C4).
Time frame: 18 weeks for each patient
CTC-PSMA change will be defined as the number of CTC-PSMA positive at C2/C4 minus the number of CTC-PSMA positive at inclusion, if feasible.
Time frame: 18 weeks for each patient
The total number of CTC will be evaluated.
Time frame: 18 weeks for each patient
The response to 177LuPSMA
Time frame: 15 months
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 18 Nov 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patients with 18F-PET-PSMA indication in people with Prostate Cancer, run by Institut Claudius Regaud 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 6 inclusion and 5 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 18 Nov 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?
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 Thibaut CASSOU-MOUNAT (+33 (0)5 31 15 65 49, Cassou-Mounat.Thibaut@iuct-oncopole.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of patients presenting at least one (i.e >0) CTC-PSMA positive. (time frame: 1 day for each patient). 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 18 Nov 2025.