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

Not Applicable

Recruiting

• Conditions: Prostate Cancer
• Interventions: Diagnostic Test: PSMA PET/CT

• Registration Number: NCT06398613
• Lead Sponsor: Oslo University Hospital

Brief 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).

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 Timeline

• Study Start: 2024-04-26
• Study First Submitted: 2024-04-30
• Study First Submitted QC: 2024-04-30
• Status Verified: 2024-05
• Study First Posted: 2024-05-03
• Last Update Submitted: 2024-12-28
• Last Update Posted: 2024-12-31
• Primary Completion: 2029-12-31
• Study Completion: 2029-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 600

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PrePSMA Arm B	PSMA PET/CT	Patients examined with PSMA PET/CT preoperatively and treated with RALP + ePLND if PSMA is positive. If PSMA PET/CT is negative, only RALP will be done

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Oslo University Hospital; 🇳🇴 Oslo, Norway