Actively Recruiting

Age: 18Years +
MALE
ID06700057

Optimization and Safety of 177Lu-PSMA-617 Nuclear Medicine Treatment for Prostate Cancer

Led by Institut Bergonié · Updated on 2026-01-30

50

Participants Needed

1

Research Sites

56 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are conducting an observational study to evaluate how the dose of radiation delivered by 177Lu-PSMA-617 to prostate tumors and nearby organs may predict treatment response and side effects in men with metastatic prostate cancer. The study focuses on patients with progressive, castration-resistant prostate cancer that overexpresses PSMA and who have previously received chemotherapy and hormone therapy. Data are collected from routine care without changing treatment or management. The treatment involves six standard cycles of 177Lu-PSMA-617 given every six weeks at a fixed dose of 7.4 GBq. Patients are selected based on a PET/CT scan that confirms PSMA expression, ensuring the treatment targets the cancer effectively. Dosimetric calculations are done using scintigraphic images taken after each treatment to measure radiation absorbed by tumors and organs. Participants undergo usual care at the nuclear medicine department, where imaging scans and clinical data are collected throughout treatment and follow-up, lasting about 10 months. Researchers analyze total radiation doses in relation to prostate-specific antigen levels, tumor response, and functional assessments to better understand treatment effects and safety. The study collects data from imaging, laboratory results, and monitoring during and after treatment without changing clinical routines.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Male patient aged 18 years or older
  • Diagnosed with progressive, metastatic, castration-resistant prostate cancer
  • Overexpression of prostate specific membrane antigen (PSMA) confirmed
  • Treated with taxane chemotherapy and at least one second-generation hormone therapy (apalutamide, enzalutamide, darolutamide, or abiraterone-prednisone)
  • Able to lie still for approximately one hour for imaging
  • Residence within two hours' drive of the Institut Bergonié
  • No opposition to use of medical data for research purposes
Not Eligible

You will not qualify if you...

  • None reported

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Monitoring

Duration - Approximately 10 months

Participants who undergo routine nuclear medicine treatment with 177Lu-PSMA-617 are observed. Data including treatment details, anatomical and scintigraphic imaging, and treatment effects are collected from their usual care.

6 treatment cycles spaced 6 weeks apart

Trial Site Locations

Total: 1 location

1

Institut Bergonie

Bordeaux, France, 33600

Actively Recruiting

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Research Team

N

Nadège ANIZAN

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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