Diagnostic accuracy of Gallium-68 PSMA-PET/CT in newly diagnosed high-risk prostate cancer patients Diagnostische accuratesse van Gallium-68 PSMA-PET/CT bij nieuw-gediagnosticeerde patienten met hoog-risico prostaatcarcinoom
Conditions
Interventions
None
Sponsors
University Medical Center Utrecht
Eligibility
Inclusion criteria
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 3. Written informed consent 4. Age ¡Ý18 years
Exclusion criteria
Exclusion criteria: 1. History of prior diagnosed or treated PCa. 2. Known concomitant malignancies (except Basal Cell Carcinoma of the skin). 3. Any unrelated illness that in the judgment of the investigator will significantly affect patient¡¯s clinical status. 4. Unwillingness or inability to undergo PSMA-PET/CT.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Patient and lesion-based diagnostic accuracy (sensitivity, specificity, PPV and NPV) of PSMA-PET/CT in detection of lymph node metastases. | — |
Secondary
| Measure | Time frame |
|---|---|
| a. Diagnostic performance of PSMA-PET/CT in detection of distant metastases. b. Diagnostic performance of PSMA-PET/CT in staging of the primary tumor in the prostate specimen. c. Detection rate of PSMA-PET/CT as a function of PSA level and size of suspected lymph nodes. d. Diagnostic performance of PSMA-PET/CT versus conventional imaging (skeletal scintigraphy, MRI of the prostate) in detection of metastases. e. Change of management induced by PSMA-PET/CT findings. 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. | — |
Contacts
Public ContactL.W.M. van Kalmthout
UMC Utrecht, Department of Radiology and Nuclear Medicine
Outcome results
None listed