NCT06398613Recruiting
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 · Last updated 31 Dec 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 600 (estimated)
- First submitted
- 30 Apr 2024
- Start date
- 26 Apr 2024
- Primary completion date
- 31 Dec 2029
- Lead sponsor
- Oslo University Hospital
- Diseases
- Prostate cancer
- NCT number
- NCT06398613
What you commit to
- Study type: Interventional
- Planned participants: 600
- From 26 Apr 2024 to the primary completion date, 31 Dec 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of previously actively treated PCa
Age
- Previous malignancies (except basal cell carcinoma of the skin) that has not been recurrence-free past ≥5 years
Other
- Unwillingness or inability to undergo PSMA PET/CT and/or ePLND and RALP
- Presence of distant metastasis (cM1) on MRI imaging
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Male · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Oslo University Hospital Coordinator of this site? Confirm its status | Oslo | Norway | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.