This study has been transitioned to CTIS with ID 2024-518171-59-00 check the CTIS register for the current data. To determine if the use of Prostate-Specific Membrane Antigen Positron Emission Computer Tomography (PSMA PET/CT) as a selection tool…
ID
Source
Brief title
Condition
- Metastases
- Prostatic disorders (excl infections and inflammations)
- Male genital tract therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is the biochemical recurrence rate within two years
after surgery, defined as a PSA > 0.2 ng/ml.
Secondary outcome
To determine if of PSMA PET/CT as a staging tool may also serve as a selection
tool for ePLND in those men who are indicated for radical prostatectomy results
in fewer ePLND procedures and therefore lower overall healthcare costs and less
patient burden in terms of intervention-related complications and morbidity
compared to the current standard practice of nomogram based ePLND in radical
prostatectomy. .
Background summary
To determine de lymph node status in men with prostate cancer undergoing
radical prostatectomy, an extended pelvic lymph node dissection (e-PLND) is
advocated by the prevailing guidelines. However, e-PLND is a potential harmful
and an expensive surgical procedure. Indication for e-PLND is based on the risk
of lymph node invasion (LNI) assessed by a nomogram. With the introduction of
the PSMA-PET/CT scan, staging of prostate cancer has improved substantially
compared to conventional CT and bone scan. Although PSMA-PET/CT can detect LNI
in an early stage, it is unclear whether it can serve also as an adequate
selection tool for the indication of ePLND in patients with newly diagnosed
localized or locally advanced prostate cancer.
Study objective
This study has been transitioned to CTIS with ID 2024-518171-59-00 check the CTIS register for the current data.
To determine if the use of Prostate-Specific Membrane Antigen Positron Emission
Computer Tomography (PSMA PET/CT) as a selection tool for performing extended
lymph node dissection (ePLND) for prostate cancer (PCa) in the primary staging
setting results in fewer ePLND procedures, lower patient burden in terms of
intervention-related complications and morbidity, with comparable disease
prognosis, and therefore lower overall healthcare costs compared to the current
European Guideline-recommended standard practice which includes performing
ePLND in PCa patients who are candidates for radical prostatectomie with a
nomogram-calculated lymph node involvement (LNI) risk >5%.
Study design
Randomized controlled trial
Intervention
The PSMA selected indication for ePLND (intervention) is compared to the
nomogram-based indication for ePLND, which is the standard of care according to
the guideline on prostate cancer of the European Urologic Association (EAU).
Study burden and risks
The PSMA-PET/CT is a standard imaging tool in prostate cancer patients.
Potential benefits for the patients in the intervention group (PSMA -based
indication forePLND) are, lower complication rates, less disease morbidity and
possibility of *image guided surgery* based PSMA images. There is a small
increased chance of missing pathological lymph node metastases possibly
resulting in biochemical recurrence that need salvage treatment. It is assumed
that this results in comparable (non-inferior) biochemical recurrence rates,
compared with performing standard ePLND in all patients with risk of LNI >5%.
Weg door Jonkerbos 100 1
Nijmegen 6532 SZ
NL
Weg door Jonkerbos 100 1
Nijmegen 6532 SZ
NL
Listed location countries
Age
Inclusion criteria
In order to be eligible to participate in this study, a subject must meet all
of the following criteria:
1. Age >=18 years
2. Biopsy proven adenocarcinoma of the prostate
3. Indication for extended pelvic lymph node dissection (ePLND) combined with
robot assisted radical prostatectomy (RARP)
4. Suitable for robot-assisted ePLND + RARP
5. Mentally competent and understanding of benefits and potential burden of the
study
6. Written informed consent
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded
from
participation in this study:
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 PSMA PET/CT and/or ePLND
4. PSMA non-avid PCa (local tumor activity)
5. Presence of distant metastasis (M1)
Design
Recruitment
Medical products/devices used
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 |
|---|---|
| EU-CTR | CTIS2024-518171-59-00 |
| EudraCT | EUCTR2021-002055-12-NL |
| ClinicalTrials.gov | NCT05000827 |
| CCMO | NL76042.091.21 |