Study protocol for a prospective, multi-centered randomized controlled trial comparing pelvic fascia-sparing radical prostatectomy with conventional robotic-assisted prostatectomy: The PARTIAL trial

Judith Stangl-Kremser; Keith Kowalczyk; Edward M Schaeffer; Mohamad Allaf; Douglas Scherr; Ximing Yang; Andres Matoso; Norio Azumi; Brian Robinson; Andrew Vickers; Jim C Hu

doi:10.1016/j.cct.2023.107168

Study protocol for a prospective, multi-centered randomized controlled trial comparing pelvic fascia-sparing radical prostatectomy with conventional robotic-assisted prostatectomy: The PARTIAL trial

Contemp Clin Trials. 2023 May:128:107168. doi: 10.1016/j.cct.2023.107168. Epub 2023 Apr 2.

Authors

Affiliations

¹ Department of Urology, Weill Cornell Medicine, 525 E 68(th) Street, New York, NY 10065, USA.
² Department of Urology, Georgetown University, 3800 Reservoir Road, NW, Washington, DC 20007, USA.
³ Department of Urology, Northwestern University, 676 N Saint Clair, Chicago, IL 60611, USA.
⁴ Department of Urology, Johns Hopkins University, 600 North Wolfe Street, Baltimore, MD 21287, USA.
⁵ Department of Pathology, Weill Cornell Medicine, 525 E 68(th) Street, New York, NY 10065, USA.
⁶ Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, 485 Lexington Ave, New York, NY 10017, USA.
⁷ Department of Urology, Weill Cornell Medicine, 525 E 68(th) Street, New York, NY 10065, USA. Electronic address: jch9011@med.cornell.edu.

PMID: 37015291
DOI: 10.1016/j.cct.2023.107168

Abstract

Background: Pelvic fascia-sparing robotic-assisted radical prostatectomy (PFS-RARP) is a novel approach that spares the endopelvic fascia ventral to the prostate. The preservation of more native structures compared to conventional robotic-assisted radical prostatectomy (RARP) may lead to faster recovery of urinary function, fewer penile changes, and decreased inguinal hernia sequelae, but may have a higher risk for positive surgical margins and poorer cancer control. However, high-level evidence is absent. The PARTIAL trial is a surgical randomized controlled trial (RCT) aiming to bridge this evidence gap (NCT05155501).

Methods: We describe a prospective RCT with a projected enrollment of 600 men randomized to PFS-RARP vs. RARP. The primary outcome is cancer control (positive surgical margins and prostate-specific antigen failure) and secondary outcomes include health-related quality of life pertaining to urinary and sexual function, decision regret, and adverse events (30-day complications, inguinal hernias, penile shortening, and Peyronie's disease). The anticipated duration of trial participation is 24 months. Study participation is incentivized with the use of innovative methodologies such as a novel, two-stage informed consent and a validated web-based interface to monitor patient-reported symptoms and empower individuals to improve their recovery.

Conclusion: If PFS-RARP is non-inferior to RARP in terms of cancer control and has better functional outcomes, it should be the surgical standard of care for men with localized prostate cancer. Using the innovative two-stage consent process, completion of the trial will not only provide much needed evidence on one of the most common cancer surgeries but also insight on improving surgical RCT methodology. Trial status This trial is registered at ClinicalTrials.gov (NCT05155501; first posted on December 13, 2021); Institutional approval number: WCM IRB # 21-07023781, BRANY's initial approval event ID # 186333. The trial is not yet recruiting.

Keywords: Outcome research; Prostate cancer; Prostatectomy; Study protocol.

Publication types

Clinical Trial Protocol
Research Support, Non-U.S. Gov't

MeSH terms

Fascia
Humans
Male
Margins of Excision
Multicenter Studies as Topic
Prostate
Prostatectomy / adverse effects
Prostatic Neoplasms* / surgery
Randomized Controlled Trials as Topic
Robotic Surgical Procedures* / adverse effects
Treatment Outcome

Associated data

ClinicalTrials.gov/NCT05155501