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

NCT06917781 | Recruiting

• 1 other identifier: 25GENH01
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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. 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).

Conditions

Prostate Cancer

Keywords

Prostate Cancer; 18F-PET-PSMA; Circulating Tumor Cells; Liquid biopsy

Outcome Measures

Primary Outcomes (1)

• 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).

  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).

  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.

  18 weeks for each patient

• The total number of CTC will be evaluated.

  18 weeks for each patient

• The response to 177LuPSMA

  15 months

Study Arms (1)

Patients with prostate cancer

OTHER

Other: Patients with 18F-PET-PSMA indication

Interventions

Patients with 18F-PET-PSMA indication OTHER

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.

Patients with prostate cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Institut Claudius Regaud: lead

Study Sites (1)

IUCT-O

Toulouse, France

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms; Neoplastic Cells, Circulating

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Neoplasm Metastasis; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Thibaut CASSOU-MOUNAT

CONTACT

+33 (0)5 31 15 65 49; Cassou-Mounat.Thibaut@iuct-oncopole.fr

Frédéric COURBON

CONTACT

+33 (0)5 31 15 56 27; courbon.frederic@iuct-oncopole.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2025
• First Posted: April 8, 2025
• Study Start: October 28, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2028
• Last Updated: November 18, 2025

Record last verified: 2025-11

Locations

FR (1)