Diagnostic Performance of prostate specific membrane antigen (PSMA) positron emission tomography/computed tomography (PET/CT) imaging for Pre-operative lymph Node assessment in intermediate and high-risk prostate cancer.
- Conditions
- Prostate cancerMedDRA version: 21.0Level: LLTClassification code 10036946Term: Prostatic cancerSystem Organ Class: 100000004864Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
- Registration Number
- EUCTR2020-003323-42-FR
- Lead Sponsor
- CHRU de Brest
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Male
- Target Recruitment
- 150
- 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 110
- 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;
- Impossible to lie down for at least an hour;
- Life expectancy < 12 months;
- Karnofsky score < 70 or ECOG score > 2.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method