An interventional study of Patients with 18F-PET-PSMA indication in Prostate Cancer, sponsored by Institut Claudius Regaud. Recruiting at 1 site in France. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-11-18.
Sponsored by Institut Claudius Regaud · Not applicable, Interventional, and Other
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).
7,046 studies on the registry are indexed under Prostatic Neoplasms; 1,580 are open to participants now.
This study's planned enrollment of 80 is above the median of 60 across 5,348 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Institut Claudius Regaud is the lead sponsor of 117 studies on the registry; 33 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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).
Time frame: 1 day for each patient
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
It will be evaluated according to investigator judgement and PSMA uptake alteration on PET as proposed in PROMISE V2.
Time frame: 15 months
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