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Preoperative PSMA PET/CT as Triage for ePLND in Patients Scheduled for RALP (PrePSMA) - Trial NCT06398613

Access comprehensive clinical trial information for NCT06398613 through Pure Global AI's free database. This phase not specified trial is sponsored by Oslo University Hospital and is currently Recruiting. The study focuses on Prostate Cancer. Target enrollment is 600 participants.

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NCT06398613
Recruiting
diagnostic test
Trial Details
ClinicalTrials.gov โ€ข NCT06398613
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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)

Study Focus

Prostate Cancer

PSMA PET/CT

Interventional

diagnostic test

Sponsor & Location

Oslo University Hospital

Oslo, Norway

Timeline & Enrollment

N/A

Apr 26, 2024

Dec 31, 2029

600 participants

Primary Outcome

Difference between Arm A and Arm B in biochemical recurrence (BCR) rate between groups within 2 years after initiation of RALP

Summary

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).

ICD-10 Classifications

Malignant neoplasm of prostate
Hyperplasia of prostate
Disorder of prostate, unspecified
Other disorders of prostate
Carcinoma in situ: Prostate

Data Source

ClinicalTrials.gov

NCT06398613

Non-Device Trial