Actively Recruiting

Phase Not Applicable
Age: 18Years +
MALE
NCT06450548

Dynamic 68Ga-PSMA and 18F-FDG PET/CT Analysis Prior to 177Lu-PSMA

Led by Centre Henri Becquerel · Updated on 2026-01-02

60

Participants Needed

1

Research Sites

156 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Prostate cancer is a significant health issue, representing 21.8% of male cancer cases in France with over 449,000 new cases in 2018. It's the cause of 10% of cancer deaths in Europe. The PSMA is a target for mCRPC treatment, with therapies like 177Lu-PSMA-617 delivering radiation to cancer cells. The Vision study showed that 177Lu-PSMA-617, combined with standard care, improved survival rates significantly compared to standard care alone.The French ANSM authorized 177Lu-PSMA-617 for mCRPC under certain conditions. Patients must have histologically confirmed mCRPC, be progressive despite treatment, and have PSMA-positive imaging. Imaging assessments include PSMA PET/CT and 18F-FDG PET/CT to identify FDG-positive and PSMA-negative sites, which are associated with a poorer prognosis. Parametric analysis using dynamic PET could improve lesion characterization, aiding in treatment decisions. This is the focus of the PyPET study. The main objective focuses on a comparative analysis of data from dynamic parametric analysis (metabolic influx rate Ki, volume of distribution Vd) and static analysis (standard at 1 hour) using 18F-FDG and 68Ga-PSMA PET/CT for diagnosing metastases, especially in the liver, lymph nodes, and bones. It aims to assess the effectiveness of these imaging techniques in accurately identifying metastatic sites.

CONDITIONS

Official Title

Dynamic 68Ga-PSMA and 18F-FDG PET/CT Analysis Prior to 177Lu-PSMA

Who Can Participate

Age: 18Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed informed consent.
  • Progressive metastatic castration-resistant prostate adenocarcinoma treated with taxane chemotherapy and at least one anti-androgen hormone therapy.
  • Evaluated by 18F-FDG and 68Ga-PSMA PET/CT before possible 177Lu-PSMA treatment.
  • Affiliated with or beneficiary of a social protection scheme.
  • WHO stage 0 or 1.
Not Eligible

You will not qualify if you...

  • Unable to understand the study or comply with trial requirements due to language, psychological, or geographical issues.
  • Unable to undergo examinations or maintain prolonged lying position due to conditions such as back pain.

AI-Screening

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Trial Site Locations

Total: 1 location

1

Centre Henri Becquerel

Rouen, France, 76000

Actively Recruiting

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Research Team

P

Pierre Decazes, MD,PhD

CONTACT

D

Doriane Richard, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

OTHER

Number of Arms

1

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