Prospective Randomized Controlled Trial To Evaluate The Prognostic Role of Lymph Node Dissection In Men With Prostate Cancer Treated With Radical Prostatectomy (PREDICT-Study)

• Conditions: Prostate cancer; prostate carcinoma; 10038597; 10036958; 10025506

• Registration Number: NL-OMON55216
• Lead Sponsor: Antoni van Leeuwenhoek Ziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 284

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Persistent PSA rate 6 months after radical prostatectomy (persistent PSA is<br /><br>defined as a PSA value >= 0.1 ng/ml)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>• Biochemical recurrence-free survival (BCR-FS) (BCR is defined as a PSA value<br /><br>>= 0.2 ng/ml).<br /><br>• Metastasis-free survival<br /><br>• Incidence of lymphoceles and complications six months after RP (using<br /><br>Clavien-Dindo classification)<br /><br>• Incidence of adjuvant therapy (androgen deprivation therapy, radiation<br /><br>therapy or salvage lymph node dissection)<br /><br>• Functional outcomes (quality of life, continence, potency)</p><br>