Prostate Cancer Burden and Heterogeneity Evaluation Towards Liquid Biopsy: a Correlation Study to 18FDCFPyL PET and Patients Outcome (TAYLOR)

November 14, 2025 updated by: Institut Claudius Regaud

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age ≥ 18 years
  2. Histologically confirmed adenocarcinoma of the prostate
  3. Indication for 18F-PET-PSMA imaging
  4. Signed written informed consent
  5. Patient able to participate and willing to give informed consent prior performance of any study-related procedures and to comply with the study protocol
  6. Patient affiliated to a Social Health Insurance in France.

Exclusion Criteria:

  1. Patients with a contraindication to 18F-PET-PSMA
  2. Patient with an established neuro endocrine prostate cancer
  3. Concurrent malignancy known to express a significant amount of PSMA (renal cancer, salivary gland tumors)
  4. 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
  5. Patient who has forfeited his freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Patients with prostate cancer
Other: Patients with 18F-PET-PSMA indication

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
1 day for each patient

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
18 weeks for each patient
The total number of CTC will be evaluated.
Time Frame: 18 weeks for each patient
18 weeks for each patient
The response to 177LuPSMA
Time Frame: 15 months
It will be evaluated according to investigator judgement and PSMA uptake alteration on PET as proposed in PROMISE V2.
15 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Claudius Regaud

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 28, 2025

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

October 1, 2028

Study Registration Dates

First Submitted

April 1, 2025

First Submitted That Met QC Criteria

April 1, 2025

First Posted (Actual)

April 8, 2025

Study Record Updates

Last Update Posted (Actual)

November 18, 2025

Last Update Submitted That Met QC Criteria

November 14, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25GENH01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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