Preoperative PSMA PET/CT As Triage for EPLND in Patients Scheduled for RALP (PrePSMA) (PrePSMA)

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

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).

Study Overview

• Status: Recruiting
• Conditions: Prostate Cancer
• Intervention / Treatment: Diagnostic test: extended pelvic lymph node dissection (ePLND)

Detailed Description

Due to the latest change in EAU guidelines in May 2024, all eligible patients will undergo PSMA PET/CT. Patients will then be randomized between RALP and ePLND (Arm A) and RALP +/- ePLND (arm B): If PSMA PET/CT detect suspicious pelvic nodes, the patient will undergo ePLND concomitant with RALP. If PSMA PET/CT is negative, only RALP will be performed .

Primary outcome measures:

Difference in biochemical recurrence (BCR) rate between arm A and arm B within 2 years after initiation of primary treatment (BCR ≥ 0.2 ng/ml).

Secondary outcome measures:

Difference between Arm A and Arm B for surgical complications, persistent PSA after RALP and initiation of salvage therapy

• Study Type: Interventional
• Enrollment (Estimated): 600
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Viktor Berge, PhD; Phone Number: +4791599615; Email: vikber@ous-hf.no

Study Locations

• Norway
  • Oslo, Norway, 4950
    • Recruiting
    • Oslo University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Diagnostic test: extended pelvic lymph node dissection (ePLND); Prostate-Specific Membrane Antigen Emission Tomography/Computed Tomography (PSMA PET/CT) will done preoperatively in both arms of the study. In arm A all patients will undergo ePLND, in arm B only patients with positive PSMA PET/CT will undergo ePLND

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference between Arm A and Arm B in biochemical recurrence (BCR) rate between groups within 2 years after initiation of RALP	BCR is defined as PSA ≥ 0.2 ng/ml	2 years after initiation of primary treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference between Arm A and Arm B in incidence and types of surgical complications	Clavien Dindo classification of complications will be used	3 months follow up
Difference between Arm A and Arm B in initiation of salvage therapy	Salvage therapy is salvage radiation therapy, salvage surgery and ADT	2 years follow up
Difference between Arm A and Arm B in persistent PSA after RALP	If the PSA value 6 weeks postoperatively is > 0.10 ng/ml the patient has persistent PSA	2 months after RALP

Collaborators and Investigators

• Sponsor: Oslo University Hospital
• Collaborators: University Hospital, Akershus
• Investigators: Principal Investigator: Viktor Berge, Oslo University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 26, 2024
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029

Study Registration Dates

• First Submitted: April 30, 2024
• First Submitted That Met QC Criteria: April 30, 2024
• First Posted (Actual): May 3, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 28, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: PSMA PET/CT, ePLND
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: REK 688379

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No