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

Institut Bergonié

Status: Enrolling

Conditions: Metastasis; Prostate Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT06700057

IB 2024 - DOSIPROSTATE

Details and patient eligibility

About

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.

Full description

The management of patients and the administration of treatment with 177Lu-PSMA are carried out in the usual way in the nuclear medicine department of the Institut Bergonié, and are not modified in any way.

The treatment regimen is standard, with 6 cycles spaced 6 weeks apart at a fixed dose of 7.4 GBq. Patients are selected on the basis of a 68Ga-PSMA-11 PET/CT scan to assess whether PSMA is properly expressed.

Only data are collected for the study and they are derived from the usual management of patients treated with 177Lu-PSMA at the Institut Bergonié: information on the treatment, anatomical data and 177Lu-PSMA fixation in lesions and tissues, scintigraphic images acquired post-treatment, data on monitoring the effects of the treatment, 68Ga-PSMA PET/CT images.

Enrollment: 50 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patient aged 18 and over.

2. Patient with indication for or having started or completed treatment with 177Lu-PSMA-617 since 01/11/2023:

   1. Progressive, metastatic, castration-resistant prostate cancer,
   2. overexpressing prostate specific membrane antigen (PSMA)
   3. treated with taxane chemotherapy and at least one 2nd generation hormone therapy (apalutamide, enzalutamide, darolutamide, abiraterone-prednisone).

3. Patient able to lie still for 1 hour for image acquisition.

4. Patient's place of residence < 2 hours' drive from the Institut Bergonié.

5. Patient has not expressed any opposition to the use of his/her medical data for research purposes.

Exclusion criteria

None