Preoperative PSMA PET/CT as Triage for ePLND in Patients Scheduled for RALP (PrePSMA)

Prostate Cancer Clinical Trial

— PrePSMA  

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06398613
• Other study ID #: REK 688379
• Status: Recruiting
• Phase: N/A
• Start date: April 26, 2024
• Est. completion date: December 31, 2029

Study information

• Verified date: May 2024
• Source: Oslo University Hospital
• Contact: Viktor Berge, PhD
• Phone: +4791599615
• Email: vikber[@]ous-hf.no
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Description:

Eligible for the study is patients scheduled for RALP and ePLND according to current practice. Patients will be randomized between RALP and ePLND (Arm A) and PSMA PET/CT (arm B). If PSMA PET/CT detect suspicious pelvic nodes, the patient will undergo ePLND comcomitant 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: December 31, 2029
• Est. primary completion date: December 31, 2029
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Biopsy proven newly diagnosed adenocarcinoma of the prostate

• Indication for ePLND combined with RALP (Briganti 2019 nomogram risk >7%)

• Written informed consent

• No known allergies for PSMA tracer

Exclusion Criteria:

• History of prior diagnosed or treated PCa

• Known concomitant malignancies (except Basal Cell Carcinoma of the skin)

• Unwillingness or inability to undergo PSMA PET/CT and/or ePLND and RALP

• If MRI shows distant metastasis to non-regional lymph nodes (M1a) or bone metastasis (M1b) on MRI imaging

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Diagnostic Test:
• PSMA PET/CT
Prostate-Specific Membrane Antigen Emission Tomography/Computed Tomography (PSMA PET/CT) will done preoperatively

Locations

Country	Name	City	State
Norway	Oslo University Hospital	Oslo

Sponsors (2)

Lead Sponsor	Collaborator
Oslo University Hospital	University Hospital, Akershus

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Difference between Arm A and Arm B in incidence and types of surgical complications	Clavien Dindo classification of complications will be used	3 months follow up
Secondary	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	6 weeks after RALP
Secondary	Difference between Arm A and Arm B in initiation of salvage therapy	Salvage therapy is salvage radiation therapy, salvage surgery and ADT	2 years follow up