18F-PSMA-1007 PET/CT in primary staging of prostate cancer
- Conditions
- intermediate-high risk prostate cancer, primary staging, diagnostics
- Registration Number
- NL-OMON24419
- Lead Sponsor
- Canisius Wilhelmina ZiekenhuisWeg door Jonkerbos 1006532 SZ NijmegenThe Netherlands
- Brief Summary
ot applicable
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 100
Inclusion Criteria
1.Biopsy proven adenocarcinoma of the prostate;
2.Indication for (super)extended pelvic lymph node dissection (PLND - with or without robot-assisted laparoscopic prostatectomy);
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 Diagnostic accuracy (sensitivity, specificity, PPV and NPV) of 18F-PSMA-1007 PET/CT for the detection of (regional) lymph node metastases in the initial staging of intermediate-to high risk PCa patients.
- Secondary Outcome Measures
Name Time Method a. Diagnostic accuracy (specificity, PPV) of 18F-PSMA-1007 PET/CT for the detection of distant (bone) metastases.<br /><br>b. Diagnostic accuracy of 18F-PSMA-1007 PET/CT in staging of the primary tumor in the<br>radical prostatectomy specimen.<br /><br>c. Diagnostic accuracy of 18F-PSMA-1007 PET/CT for different risk groups (according to the d¡¯Amico classification ¨C see chapter 5.1.3), nomogram risk scores, and the size of malignant lymph nodes.<br /><br>d. Diagnostic performance of 18F-PSMA-1007 PET/CT versus conventional imaging (skeletal scintigraphy, MRI of the prostate) in detection of local tumor site and metastases.<br /><br>e. Change of management induced by 18F-PSMA-1007 PET/CT findings specifically.<br /><br>f. Cost-effectiveness of 18F-PSMA-1007 PET/CT versus (super)extended PLND (e.g. mean hospital length of stay, morbidity-associated costs) for the detection of (regional)<br>LNMs.<br>