Clinical and Dosimetric Study of Patients Treated With 177Lu-PSMA-617 for Prostate Cancer.

NCT06700057 | Recruiting

• 1 other identifier: IB 2024 - DOSIPROSTATE
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Single-centre, retrospective and prospective observational study. This study aims to evaluate the dose delivered by radiation to the tumour and organs at risk, as a factor predicting response and the appearance of toxicities. Dosimetric calculations are made for each treatment using scintigraphic images acquired following injection of 177Lu-PSMA-617.

Conditions

Prostate Cancer; Metastasis

Keywords

Radiopharmaceutical drug

Outcome Measures

Primary Outcomes (1)

• Median of total absorbed-dose of 177Lu-PSMA-617 at total tumor volume as a function of prostate-antigen specific (PSA) response

  To assess the association between the total absorbed-dose of treatment at total tumor volume and the efficacy of treatment in terms of PSA response rate (PSA50-RR). PSA50-RR is defined by the proportion of patients with a decrease ≥ 50% in PSA concentration from pre-treatment baseline, confirmed by a subsequent PSA assessment performed at least 3 weeks later. Absorbed-dose of treatment at total tumor volume, expressed in Gray (Gy), is calculated for each course of 177Lu-PSMA-617 (every 6 weeks +/- 1 week) from SPECT/CT images acquired post administration with PlanetDose software (DOSIsoft). The total absorbed dose in Gray (Gy) is defined by the sum of absorbed doses over all courses of treatment performed.

  From pre-treatment baseline to the end of treatment and after the end of treatment, i.e approximately 10 months.

Secondary Outcomes (2)

• Median of total absorbed-dose of 177Lu-PSMA-617 at total tumor volume as a function of best overall response (RECIST v1.1)

  From pre-treatment baseline to the end of treatment and after the end of treatment, i.e approximately 10 months.

• Median of total absorbed-dose of 177Lu-PSMA-617 at total tumor volume as a function of objective functional response (nuclear physician assessment)))

  From pre-treatment baseline to the end of treatment (Dose) and at the end of treatment (bjective functional response), i.e approximately 10 months.

Eligibility Criteria

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

Study Population

Patients with metastatic castration-resistant prostate cancer.

You may qualify if:

• Patient aged 18 and over.
• Patient with indication for or having started or completed treatment with 177Lu-PSMA-617 since 01/11/2023:
• Progressive, metastatic, castration-resistant prostate cancer,
• overexpressing prostate specific membrane antigen (PSMA)
• treated with taxane chemotherapy and at least one 2nd generation hormone therapy (apalutamide, enzalutamide, darolutamide, abiraterone-prednisone).
• Patient able to lie still for 1 hour for image acquisition.
• Patient's place of residence \< 2 hours' drive from the Institut Bergonié.
• Patient has not expressed any opposition to the use of his/her medical data for research purposes.

You may not qualify if:

• None

Sponsors & Collaborators

• Institut Bergonié: lead

Study Sites (1)

Institut Bergonie

Bordeaux, 33600, France

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

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

Study Officials

• Nadège ANIZAN

  Institut Bergonié

  STUDY DIRECTOR

Central Study Contacts

Nadège ANIZAN

CONTACT

+33556333347; n.anizan@bordeaux.unicancer.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2024
• First Posted: November 21, 2024
• Study Start: November 1, 2023
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: January 30, 2026

Record last verified: 2026-01

Locations

FR (1)