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

University of Oslo (UIO)

Status: Enrolling

Conditions: Prostate Cancer

Treatments: Diagnostic Test: extended pelvic lymph node dissection (ePLND)

Study type: Interventional

Funder types: Other

Identifiers

NCT06398613

REK 688379

Details and patient eligibility

About

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).

Full 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

Enrollment: 600 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

600 participants in 2 patient groups

RALP + ePLND Arm A

No Intervention group

Description:

RALP + ePLND

RALP +/- ePLND Arm B

Experimental group

Description:

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.

Treatment:

Diagnostic Test: extended pelvic lymph node dissection (ePLND)