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

Oslo University Hospital600 enrolled

Overview

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).

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

600

Conditions

Prostate Cancer

Interventions

extended pelvic lymph node dissection (ePLND)DIAGNOSTIC_TEST

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

Eligibility

Sex: MALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Oslo University Hospital

Oslo, Norway

RECRUITING

Outcomes

Primary Outcomes

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

Time frame: 2 years after initiation of primary treatment

Secondary Outcomes

Difference between Arm A and Arm B in incidence and types of surgical complications

Clavien Dindo classification of complications will be used

Time frame: 3 months 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

Time frame: 2 months after RALP

Difference between Arm A and Arm B in initiation of salvage therapy

Salvage therapy is salvage radiation therapy, salvage surgery and ADT

Time frame: 2 years follow up

Central Contacts

Viktor Berge, PhD

CONTACT

+4791599615 vikber@ous-hf.no

Data from ClinicalTrials.gov

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