NL-OMON55216
Not yet recruiting
Not Applicable
Prospective Randomized Controlled Trial To Evaluate The Prognostic Role of Lymph Node Dissection In Men With Prostate Cancer Treated With Radical Prostatectomy (PREDICT-Study) - PREDICT
Antoni van Leeuwenhoek Ziekenhuis0 sites284 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Prostate cancer
- Sponsor
- Antoni van Leeuwenhoek Ziekenhuis
- Enrollment
- 284
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- Male, aged \>\= 18 years
- •\- Prostate cancer patients with a Briganti calculated risk of LN metastases
- •between 5\-20% without evidence of metastases on PSMA PET/CT requiring an ePLND
- •in the standard treatment
- •\- Scheduled for a (robot\-assisted) laparoscopic radical prostatectomy
- •\- Written informed consent
Exclusion Criteria
- •\- American Society of Anaesthesiology (ASA) classification \> 3
- •\- Patients with a contraindication for a lymphadenectomy
- •\- Neoadjuvant hormone deprivation therapy
- •\- Absence or withdrawal of an informed consent
- •\- Evidence of metastases on PSMA PET/CT
Outcomes
Primary Outcomes
Not specified
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