Clinical Trial Protocol for prePSMA: A Multicenter, Randomized, Noninferiority Trial of Preoperative Prostate-specific Membrane Antigen Positron Emission Tomography/Computed Tomography as Triage for Extended Pelvic Lymph Node Dissection in Patients Scheduled for Robot-assisted Laparoscopic Radical Prostatectomy

Lars F Qvigstad; Kirsti Aas; Andreas Tulipan; Knut H Hole; Anne H Storås; Clara Hammarström; Reza Ghiasvand; Stein H Holmedal; Viktor Berge

doi:10.1016/j.euf.2025.07.010

Clinical Trial Protocol for prePSMA: A Multicenter, Randomized, Noninferiority Trial of Preoperative Prostate-specific Membrane Antigen Positron Emission Tomography/Computed Tomography as Triage for Extended Pelvic Lymph Node Dissection in Patients Scheduled for Robot-assisted Laparoscopic Radical Prostatectomy

Eur Urol Focus. 2025 Nov;11(6):915-920. doi: 10.1016/j.euf.2025.07.010. Epub 2025 Jul 28.

Authors

Lars F Qvigstad¹, Kirsti Aas², Andreas Tulipan³, Knut H Hole⁴, Anne H Storås⁵, Clara Hammarström⁶, Reza Ghiasvand⁷, Stein H Holmedal⁸, Viktor Berge⁹

Affiliations

¹ Department of Cancer Surgery, The Norwegian Radium Hospital, Oslo University Hospital, Oslo, Norway; Institute of Clinical Medicine, University of Oslo, Oslo, Norway. Electronic address: larqvi@ous-hf.no.
² Institute of Clinical Medicine, University of Oslo, Oslo, Norway; Department of Urology, Akershus University Hospital, Lørenskog, Norway.
³ Department of Radiology and Nuclear Medicine, The Norwegian Radium Hospital, Oslo University Hospital, Oslo, Norway; Department of Radiology, Nuclear Medicine/PET Centre, Haukeland University Hospital, Bergen, Norway.
⁴ Institute of Clinical Medicine, University of Oslo, Oslo, Norway; Department of Radiology and Nuclear Medicine, The Norwegian Radium Hospital, Oslo University Hospital, Oslo, Norway.
⁵ Department of Oncology, The Norwegian Radium Hospital, Oslo University Hospital, Oslo, Norway.
⁶ Department of Pathology, Akershus University Hospital, Lørenskog, Norway.
⁷ Oslo Centre for Biostatistics and Epidemiology, Oslo Hospital Service, Oslo University Hospital, Oslo, Norway; Department of Research, Cancer Registry of Norway, Norwegian Institute of Public Health, Oslo, Norway.
⁸ Department of Radiology, Akershus University Hospital, Lørenskog, Norway.
⁹ Department of Cancer Surgery, The Norwegian Radium Hospital, Oslo University Hospital, Oslo, Norway; Institute of Clinical Medicine, University of Oslo, Oslo, Norway.

PMID: 40731245
DOI: 10.1016/j.euf.2025.07.010

Abstract

prePSMA is a randomized controlled trial in which patients with high-risk prostate cancer and selected cases with intermediate-risk disease are randomized to a control arm in which all patients undergo extended pelvic lymph node dissection (ePLND), or an experimental arm in which ePLND is only performed in patients with positive preoperative findings on prostate-specific membrane antigen positron emission tomography/computed tomography.

Publication types

Clinical Trial Protocol

MeSH terms

Equivalence Trials as Topic
Humans
Laparoscopy* / methods
Lymph Node Excision* / methods
Male
Multicenter Studies as Topic
Pelvis
Positron Emission Tomography Computed Tomography* / methods
Preoperative Care / methods
Prostatectomy* / methods
Prostatic Neoplasms* / diagnostic imaging
Prostatic Neoplasms* / pathology
Prostatic Neoplasms* / surgery
Robotic Surgical Procedures* / methods
Triage / methods