PSMA-PET/CT in Primary Staging of Prostate Cancer
Recruiting
- Conditions
- Diagnostic accuracy of Gallium-68 PSMA-PET/CT in newly diagnosed high-risk prostate cancer patientsDiagnostische accuratesse van Gallium-68 PSMA-PET/CT bij nieuw-gediagnosticeerde patienten met hoog-risico prostaatcarcinoom
- Registration Number
- NL-OMON28484
- Lead Sponsor
- niversity Medical Center Utrecht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 100
Inclusion Criteria
1.Biopsy proven adenocarcinoma of the prostate with an indication for pelvic lymph node dissection (with or without robot-assisted laparoscopic prostatectomy)
2.Mentally competent and understanding of benefits and potential burden of the study
Exclusion Criteria
1.History of prior diagnosed or treated PCa.
2.Known concomitant malignancies (except Basal Cell Carcinoma of the skin).
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Patient and lesion-based diagnostic accuracy (sensitivity, specificity, PPV and NPV) of PSMA-PET/CT in detection of lymph node metastases.
- Secondary Outcome Measures
Name Time Method a.Diagnostic performance of PSMA-PET/CT in detection of distant metastases.<br /><br>b.Diagnostic performance of PSMA-PET/CT in staging of the primary tumor in the prostate specimen.<br /><br>c.Detection rate of PSMA-PET/CT as a function of PSA level and size of suspected lymph nodes.<br /><br>d.Diagnostic performance of PSMA-PET/CT versus conventional imaging (skeletal scintigraphy, MRI of the prostate) in detection of metastases.<br /><br>e.Change of management induced by PSMA-PET/CT findings. <br /><br>f.Costs associated with PSMA-PET/CT as diagnostic modality additional to the regular diagnostic work-up versus conventional imaging and pelvic lymph node dissection.<br>