Status:
RECRUITING
Diagnostic Performance of PSMA PET/CT for Pre-operative Lymph Node Assessment in Intermediate and High-risk Non-metastasic Prostate Cancer (PREOP-PSMA ).
Lead Sponsor:
University Hospital, Brest
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
NA
Brief 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 deat...
Eligibility Criteria
Inclusion
- Histologically confirmed prostate cancer;
- Intermediate-risk prostate cancer (PSA level of 10- 20 ng/mL and/or Clinical tumor stage ≥ T2b and/or ISUP 2 or 3, AND with risk of lymph node extension \> 5% according to the Briganti nomogram) or high-risk prostate cancer (PSA ≥ 20 ng/mL and/or TR ≥ T2c and/or ISUP 4 or 5) according to d'Amico classification;
- Curative treatment by radical prostatectomy chosen by the multidisciplinary consultation meeting.
Exclusion
- Refusal or inability to participate in the study ;
- Low-risk prostate cancer according to D'Amico's classification, or an intermediate-risk but with a risk of lymph node extension \<5% according to Briganti's nomogram;
- Curative treatment other than surgical treatment chosen;
- Life expectancy \< 12 months;
- Karnofsky score \< 70 or ECOG score \> 2.
Key Trial Info
Start Date :
May 20 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 20 2027
Estimated Enrollment :
159 Patients enrolled
Trial Details
Trial ID
NCT04745871
Start Date
May 20 2021
End Date
May 20 2027
Last Update
September 12 2025
Active Locations (1)
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1
CHRU de Brest
Brest, France, 29609