A Study Comparing Single-Port and Multi-Port Robot-Assisted Surgery in Patients With Prostate or Kidney (Renal) Cancer

NCT07610083 | Not Yet Recruiting

• 1 other identifier: PORTAL Study
• Study Type: observational
• Target: 376
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective single-center observational study comparing single-port (SP) and multi-port (MP) robot-assisted surgery in adult patients undergoing robot-assisted radical prostatectomy (RARP) or robot-assisted partial nephrectomy (RAPN) for prostate or kidney cancer. Consecutive eligible patients will be managed according to routine clinical practice and assigned to SP or MP surgery based on predefined clinical and anatomical criteria, surgeon assessment, patient and tumor characteristics, platform availability, and surgical expertise. No randomization will be performed. The study aims to compare perioperative outcomes between the two surgical approaches, with length of hospital stay (LOS) as the primary endpoint. Secondary endpoints include intraoperative outcomes (operative time, estimated blood loss, and intraoperative complications), postoperative recovery, pain, postoperative complications, readmission rates, positive surgical margins, and hospital costs. Functional and patient-reported outcomes will also be evaluated, including urinary continence, sexual function, health-related quality of life, renal function after partial nephrectomy, decision regret, and cosmetic satisfaction.

Conditions

Prostate Cancer; Renal Cancer

Outcome Measures

Primary Outcomes (1)

• Length of hospital stay (LOS)

  Length of hospital stay (LOS), defined as the time from the end of surgery (skin closure) to hospital discharge, expressed in days or hours. Discharge will be based on predefined and standardized discharge criteria.

  Day 30

Study Arms (2)

Single-Port Robot-Assisted Surgery

Multi-Port Robot-Assisted Surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Male or female participants (≥18 years old) with a diagnosis of prostate or renal cancer candidates for RARP or RAPN.

You may qualify if:

• The participant provides written informed consent
• Male or female participants who are at least 18 years of age on the day of signing informed consent
• Men with a diagnosis of prostate or renal cancer and women with a diagnosis of renal cancer
• Pre-operative imaging performed for staging purposes (i.e. CT scan, PSMA PET) showing no suspicious evidence of distant metastases in prostate or renal cancer patients
• Suitable for RARP or RAPN.

You may not qualify if:

• Patients \< 18 years
• Mental or physical disability that may prevent the patient from satisfying the requirements of the protocol
• Inability to read and sign the informed consent
• No available pre-operative staging
• Contraindication to surgery
• Presence of distant metastases (M1)

Sponsors & Collaborators

• IRCCS San Raffaele: lead

Study Sites (1)

IRCCS Ospedale San Raffaele

Milan, 20132, Italy

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Kidney 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; Urologic Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Kidney Diseases; Urologic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chairman

Study Record Dates

• First Submitted: May 20, 2026
• First Posted: May 27, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): July 1, 2029
• Study Completion (Estimated): June 1, 2030
• Last Updated: May 27, 2026

Record last verified: 2026-05

Locations

IT (1)