Clinical trial · Interventional
Preoperative PSMA PET/CT As Triage for EPLND in Patients Scheduled for RALP (PrePSMA)
Preoperative PSMA PET/CT As Triage for Extended Pelvic Lymph Node Dissection (ePLND) in Patients Scheduled for Robot-Assisted Laparoscopic Radical Prostatectomy (RALP)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Extended pelvic lymph node dissection (ePLND) is considered the gold standard for nodal staging in men with prostate cancer (PCa). The aim of this project is to determine if preoperative prostate specific membrane antigen (PSMA) positron emission tomography (PET)/computed tomograpy (CT) can safely replace ePLND as a staging method in PCa patients undergoing robot-assisted laparoscopic radical prostatectomy (RALP).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| extended pelvic lymph node dissection (ePLND) | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- RALP + ePLND Arm A
- description
- RALP + ePLND
- type
- EXPERIMENTAL
- label
- RALP +/- ePLND Arm B
- description
- I preoperative PSMA PET/CT is positive for pelvic nodal metastasis, ePLND concomitant with RALP will be performed. If PSMA PET/CT is negative, only RALP will be done.
- interventionNames
- Diagnostic Test: extended pelvic lymph node dissection (ePLND)
Primary outcomes (1)
- measure
- Difference between Arm A and Arm B in biochemical recurrence (BCR) rate between groups within 2 years after initiation of RALP
- timeFrame
- 2 years after initiation of primary treatment
- description
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Biopsy proven diagnosed adenocarcinoma of the prostate * Indication for ePLND combined with RALP: * High-risk group (EAU) and including MRI findings indicating extra prostatic extension (Likert scale ≥4) * -ISUP GG 3 with ≥1 of the following unfavourable risk factors * cT2b-c, * ≥50% percentage of positive biopsy cores, * PSA 10-20 * cN1 selected to surgery * Written informed consent * No known allergies for PSMA tracer * 18 years and older Exclusion Criteria: * History of previously actively treated PCa * Previous malignancies (except basal cell carcinoma of the skin) that has not been recurrence-free past ≥5 years * Unwillingness or inability to undergo PSMA PET/CT and/or ePLND and RALP * Presence of distant metastasis (cM1) on MRI imaging
References
Publications (0)
Data not yet available