|- candidate number||28194|
|- NTR Number||NTR6830|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||13-nov-2017|
|- Secondary IDs||17-378/C METC|
|- Public Title||PSMA-PET/CT in Primary Staging of Prostate Cancer|
|- Scientific Title||Diagnostic accuracy of 68Ga PSMA-PET/CT in newly diagnosed prostate cancer patients
|- hypothesis||PSMA-PET/CT is an accurate diagnostic tool in detection of lymph node metastases, with a sensitivity of at least 80%. |
|- Healt Condition(s) or Problem(s) studied||Prostatic neoplasms, Diagnosis, Gallium-68, PSMA-PET/CT|
|- 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 ¡Ư18 years
|- 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.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||1-okt-2017|
|- planned closingdate||1-apr-2019|
|- Target number of participants||100|
|- Primary outcome||Patient and lesion-based diagnostic accuracy (sensitivity, specificity, PPV and NPV) of PSMA-PET/CT in detection of lymph node metastases.|
|- Secondary outcome||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.
|- Timepoints||Not applicable|
|- Trial web site|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Drs. L.W.M. van Kalmthout |
|- CONTACT for SCIENTIFIC QUERIES||Drs. L.W.M. van Kalmthout |
|- Sponsor/Initiator ||University Medical Center Utrecht (UMCU)|
(Source(s) of Monetary or Material Support)
|University Medical Center Utrecht (UMCU)|
|- Brief summary||Rationale: Prostate cancer is the most common malignancy amongst men. Lymph node metastases in patients with prostate cancer are characterized as an adverse prognostic factor and can be associated with systemic metastases. The gold standard for diagnosing lymph node metastases in locally advanced prostate cancer is extended pelvic lymph node dissection (ePLND). Since this is an invasive diagnostic procedure, MRI of the pelvis can be executed to evaluate number and nature of lymph node lesions. For detection of bone lesions, skeletal scintigraphy is currently used. Since 68Ga PSMA-PET/CT (PSMA-PET/CT) imaging is considered as a valuable imaging modality for evaluation of primary prostate cancer and it is assumed to have potential for the detection of lymph node and distant metastases at an early stage, this diagnostic tool is used on a daily base in several hospitals in the Netherlands. Usage of PSMA-PET/CT imaging is supported by current oncological guidelines. Remarkably, only few studies have assessed the diagnostic accuracy of PSMA-PET/CT in initial staging of prostate cancer, in terms of detection of lymph node and distant metastases as compared with histopathological findings.|
Objective: To evaluate diagnostic accuracy of PSMA-PET/CT in detection of lymph node metastases in initial staging of high-risk prostate cancer.
Study design: Multicenter prospective and observational cohort study.
Study population: Newly diagnosed patients with high-risk prostate cancer, considered candidates for extended pelvic lymph node dissection.
Intervention: Not applicable.
Main study parameters/endpoints: Main study parameter is patient- and lesion-based diagnostic accuracy of PSMA-PET/CT in detection of lymph node metastases. Secondary study parameters are (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 in detection of metastases, (e) change of management induced by PSMA-PET/CT findings (abandonment of pelvic lymph node dissection or alteration of initial dissection template) and (f) cost-associated with PSMA-PET/CT as diagnostic modality additional to the regular diagnostic work-up versus conventional imaging and pelvic lymph node dissection.
|- Main changes (audit trail)|
|- RECORD||13-nov-2017 - 7-dec-2017|