Preoperative PSMA PET/CT As Triage for Extended Pelvic Lymph Node Dissection (ePLND) in Patients Scheduled for Robot-Assisted Laparoscopic Radical Prostatectomy (RALP)

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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).

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: t
View:

• 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

Locations
Other Locations
Norway
Oslo University Hospital
RECRUITING
Oslo
Contact Information
Primary
Viktor Berge, PhD
vikber@ous-hf.no
+4791599615
Time Frame
Start Date: 2024-04-26
Estimated Completion Date: 2029-12-31
Participants
Target number of participants: 600
Treatments
No_intervention: RALP + ePLND Arm A
RALP + ePLND
Experimental: RALP +/- ePLND Arm B
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.
Related Therapeutic Areas
Sponsors
Collaborators: University Hospital, Akershus
Leads: Oslo University Hospital

This content was sourced from clinicaltrials.gov