Actively Recruiting

Phase Not Applicable
Age: 18Years +
MALE
NCT04745871

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

Led by University Hospital, Brest · Updated on 2025-09-12

159

Participants Needed

1

Research Sites

313 weeks

Total Duration

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AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Histologically confirmed prostate cancer
  • Intermediate-risk prostate cancer with PSA 10-20 ng/mL and/or clinical tumor stage ≥ T2b and/or ISUP 2 or 3, and risk of lymph node extension > 5% by Briganti nomogram
  • High-risk prostate cancer with PSA ≥ 20 ng/mL and/or tumor stage ≥ T2c and/or ISUP 4 or 5 as per d'Amico classification
  • Curative treatment by radical prostatectomy chosen by multidisciplinary consultation
Not Eligible

You will not qualify if you...

  • Refusal or inability to participate in the study
  • Low-risk prostate cancer or intermediate-risk with lymph node extension risk < 5% by Briganti nomogram
  • Curative treatment other than surgical treatment chosen
  • Life expectancy less than 12 months
  • Karnofsky score less than 70 or ECOG score greater than 2

AI-Screening

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Trial Site Locations

Total: 1 location

1

CHRU de Brest

Brest, France, 29609

Actively Recruiting

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Research Team

P

Philippe ROBIN

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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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 ). | DecenTrialz