To compare the diagnostic performance of new lymph node staging methods for prostate cancer (dwMRI fused with 18F-Choline PET-CT) with the current gold standard of staging, the extended pelvic lymph node dissection (ELND)
ID
Source
Brief title
Condition
- Metastases
- Genitourinary tract disorders NEC
- Renal and urinary tract therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Findings of ELND will serve as the reference standard. Analysis of PET-MR and
lymph node dissections will be performed both on a per-region and per-patient
basis. Patient- and region-based sensitivity and specificity of PET-MR will be
calculated. In addition, the complication rate of ELND will be determined after
3 months follow-up.
Secondary outcome
In addition, the complication rate of ELND will be determined after 3 months
follow-up.
Background summary
Numerous studies have shown that a classic, limited laparoscopic pelvic lymph
node dissection was inadequate in staging patients with prostate cancer. In
these studies it was proven that the extended lymph node dissection revealed in
up to 40% metastases outside the area of the classic lymph node dissection and
thus much more accurate for staging. However, this extended operation is
associated with an increased rate of complications such as (infected)
lymphocele, lymphorrhoea and postoperative haemorrhage. Hence there is need
for less invasive lymph node staging for prostate cancer. Recently choline
based radiotracers in conjunction with PET as well as diffusion-weighed MRI
have been introduced for staging and restaging of prostate cancer.
Study objective
To compare the diagnostic performance of new lymph node staging methods for
prostate cancer (dwMRI fused with 18F-Choline PET-CT) with the current gold
standard of staging, the extended pelvic lymph node dissection (ELND)
Study design
A prospective single-center diagnostic accuracy study
Study burden and risks
Burden and risks of participation to this study are relatively small.
Groot Weezenland 20
Zwolle 8011JW
NL
Groot Weezenland 20
Zwolle 8011JW
NL
Listed location countries
Age
Inclusion criteria
1. Age 18-80
2. Written informed consent
3. Biopsy proven prostate cancer cT1-T3 Nx M0
4. A chance of more than 15% of having lymph node metastases
Exclusion criteria
1. Neo-adjuvant treatments for prostate cancer .
2. Severe claustrophobia
3. Any metal prosthesis or device
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 |
|---|---|
| CCMO | NL36042.075.11 |