No registrations found.
ID
Source
Brief title
Health condition
intermediate-high risk prostate cancer, primary staging, diagnostics
Sponsors and support
Weg door Jonkerbos 100
6532 SZ Nijmegen
The Netherlands
Intervention
Outcome measures
Primary outcome
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
a. Diagnostic accuracy (specificity, PPV) of 18F-PSMA-1007 PET/CT for the detection of distant (bone) metastases.
b. Diagnostic accuracy of 18F-PSMA-1007 PET/CT in staging of the primary tumor in the
radical prostatectomy specimen.
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.
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.
e. Change of management induced by 18F-PSMA-1007 PET/CT findings specifically.
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)
LNMs.
Background summary
Over the last years, PSMA-targeting imaging strategies are gaining prominence and have been introduced into (inter)national clinical practice for both initial staging and restaging of PCa. Both 68Ga-PSMA and 18F-labelled PSMA ligands appear safe, provide intense tumor uptake and high tumor-to-background ratios, allowing high lesion detectability. However, diagnostic accuracy of the newly developed 18F-PSMA-1007 tracer has not been extensively investigated. Hence, this study aims to determine diagnostic performance of 18F-PSMA-1007 PET/CT in detection of lymph node metastases as compared to histopathological examination following PLND.
Study objective
To improve detection of metastases, radiotracers have been developed for PET/CT imaging: i.e. radiolabelled Prostate Specific Membrane Antigen (PSMA) ligands. Initial studies with Gallium-68 (68Ga-) PSMA showed promising results. The second generation of Fluorine-18 labelled (18F-) PSMA is hypothesized to offer even better diagnostics. Compared to 68Ga-PSMA, 18F-PSMA has a higher image resolution and a longer half-life. The present study therefore aims to determine diagnostic accuracy of 18F-PSMA-1007 PET/CT in initial staging of intermediate- to high risk PCa.
Study design
Inclusion of patients: 1-1-2019 up to 1-1-2020.
Data analysis: 1-1-2010 up to 1-6-2010
Publication of data: 1-10-2020
Intervention
Not applicable
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);
3. Mentally competent and understanding of benefits and potential burden of the study;
4. Written informed consent;
5. Age ¡Ý18 years.
Exclusion criteria
1. History of prior diagnosed or treated PCa.
2. Known concomitant malignancies (except Basal Cell Carcinoma of the skin).
3. Unwillingness or inability to undergo 18F-PSMA-1007 PET/CT.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL7428 |
| NTR-old | NTR7670 |
| Other | 2018-4294 : CMO dossiernummer |