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

NCT06398613 | Recruiting

• 1 other identifier: REK 688379
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

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).

Conditions

Prostate Cancer

Keywords

PSMA PET/CT, ePLND

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

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

  3 months follow up

• Difference between Arm A and Arm B in persistent PSA after RALP

  2 months after RALP

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

  2 years follow up

Study Arms (2)

RALP + ePLND Arm A

NO INTERVENTION

RALP + ePLND

RALP +/- ePLND Arm B

EXPERIMENTAL

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)

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

RALP +/- ePLND Arm B

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• years and older

You may not qualify if:

• 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

Sponsors & Collaborators

• Oslo University Hospital: lead
• University Hospital, Akershus: collaborator

Study Sites (1)

Oslo University Hospital

Oslo, 4950, Norway

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Viktor Berge

  Oslo University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Viktor Berge, PhD

CONTACT

+4791599615; vikber@ous-hf.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 30, 2024
• First Posted: May 3, 2024
• Study Start: April 26, 2024
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: December 31, 2024

Record last verified: 2024-05

Locations

NO (1)