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Recruiting NCT06398613

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

No phase Interventional Prostate Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: extended pelvic lymph node dissection (ePLND).
Who it may be relevant to
Registry conditions: Prostate Cancer. Basic parameters: from 18 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Norway
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

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).

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

Interventions

  • 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

Primary outcome measures

  • Difference between Arm A and Arm B in biochemical recurrence (BCR) rate between groups within 2 years after initiation of RALP [Time frame: 2 years after initiation of primary treatment]
Secondary outcome measures (3)
  • Difference between Arm A and Arm B in incidence and types of surgical complications [Time frame: 3 months follow up]
  • Difference between Arm A and Arm B in persistent PSA after RALP [Time frame: 2 months after RALP]
  • Difference between Arm A and Arm B in initiation of salvage therapy [Time frame: 2 years follow up]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Norway · 1 center
  • Oslo University Hospital — Oslo

Identifiers

NCT: NCT06398613 · REK 688379

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗