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

NCT ID: NCT06700057

Last Updated: 2026-01-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-11-01

Study Completion Date

2027-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Prostate Cancer Metastasis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Institut Bergonié

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nadège ANIZAN

Role: STUDY_DIRECTOR

Institut Bergonié

Locations

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Institut Bergonie

Bordeaux, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Nadège ANIZAN

Role: CONTACT

+33556333347

Facility Contacts

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Nadège ANIZAN

Role: primary

Caroline LALET

Role: backup

Other Identifiers

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IB 2024 - DOSIPROSTATE

Identifier Type: -

Identifier Source: org_study_id

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