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Diagnostic Performance of PSMA PET/CT for Pre-operative Lymph Node Assessment in Intermediate and High-risk Non-metastasic Prostate Cancer (PREOP-PSMA ).

NCT04745871 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 159

Last updated 2025-09-12

No results posted yet for this study

Summary

In France, prostate cancer is the most common cancer in men over 50 years of age (nearly 50,000 new cases per year) and is the second most common cause of cancer death in men (approximately 9,000 deaths per year). Although mortality has been declining since the end of the 1990s (about 7%/year), about 30 to 35% of them will have a biological recurrence.

Accurate assessment of local, regional and distant spread of the disease is therefore needed to design optimal personalised care for each patient, either curative or palliative.

Currently, in France, recommended disease assessment includes bone scintigraphy and Abdomino-Pelvic Magnetic Resonance Imaging. However, conventional imaging has limited performance with regard to lymph node extension.

Node dissection is the best way to assess node status. Currently, no imaging exam allows this level of accuracy.

Recently, molecular imaging has emerged as a promising tool to improve the initial extensional assessment of prostate cancer. Prostate-specific membrane antigen (PSMA) is a transmembrane glycoprotein, specific to the prostate, which is over-expressed on the surface of prostate cancer cells.

Recent studies of PSMA PET/CT as part of the initial extension assessment of prostate cancer report superior diagnostic performance in terms of sensitivity and specificity compared to conventional tests, as well as an impact of PSMA PET/CT on patient management.

Conditions

Interventions

DIAGNOSTIC_TEST

PSMA PET/CT

The PSMA PET/CT will be performed on an outpatient in the nuclear medicine department of the Brest University Hospital (CHRU). For this exam, the administration of 2-4 MBq/kg of 68Ga-HBED-CC-PSMA or 1,8-2,2 MBq/kg of 68Ga-PSMA-11 will be performed to patient by a single intravenous injection.

Sponsors & Collaborators

  • University Hospital, Brest

    lead OTHER

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-20
Primary Completion
2027-05-20
Completion
2027-05-20

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04745871 on ClinicalTrials.gov