NCT07666217

Brief Summary

This multicenter retrospective observational study aims to compare perioperative and postoperative outcomes between the da Vinci SP extraperitoneal approach (SP-EA) and the robotic multi-port transperitoneal approach (MP-TA) in robot-assisted radical prostatectomy for localized prostate cancer.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
625

participants targeted

Target at P75+ for all trials

Timeline
8mo left

Started Mar 2026

Shorter than P25 for all trials

Geographic Reach
1 country

8 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress36%
Mar 2026Mar 2027

Study Start

First participant enrolled

March 26, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 3, 2026

Completed
21 days until next milestone

First Posted

Study publicly available on registry

June 24, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2027

Last Updated

June 24, 2026

Status Verified

June 1, 2026

Enrollment Period

6 months

First QC Date

June 3, 2026

Last Update Submit

June 22, 2026

Conditions

Prostate Cancer

Keywords

Robot assisted radical prostatectomyRARPSingle portda Vinci SPExtraperitoneal approachTransperitoneal approachPropensity score matching

Outcome Measures

Primary Outcomes (2)

  • Incidence of postoperative complications and Clavien-Dindo Grade 3a or higher postoperative complications

    Postoperative complications occurring after robot assisted radical prostatectomy, including complications classified as Clavien-Dindo Grade 3a or higher.

    Within 6 and 12 months after surgery

  • Urinary continence rate

    Achievement of urinary continence after robot assisted radical prostatectomy.

    Within 6 and 12 months after surgery

Secondary Outcomes (16)

  • Total operative time

    During surgery

  • Console time

    During surgery

  • Estimated blood loss

    During surgery

  • Intraoperative transfusion rate

    During surgery

  • Nerve sparing rate

    During surgery

  • +11 more secondary outcomes

Study Arms (2)

SP-EA group

Patients who underwent robot assisted radical prostatectomy using the da Vinci SP extraperitoneal approach.

MP-TA group

Patients who underwent robot assisted radical prostatectomy using the robotic multi port transperitoneal approach.

Eligibility Criteria

Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with localized prostate cancer who underwent robot assisted radical prostatectomy using either the da Vinci SP extraperitoneal approach or the robotic multi port transperitoneal approach at participating institutions in Japan.

You may qualify if:

  • Patients with localized prostate cancer (clinical stage T1-T3a, N0, M0) eligible for radical prostatectomy
  • Patients who underwent RARP via SP-EA or MP-TA on or after January 1, 2023
  • Patients with available postoperative follow-up data for ≥6 months (≥166 days) \*note 1)

You may not qualify if:

  • Patients who have expressed an intention to refuse the use of their data for this study
  • Patients who underwent RARP with pelvic lymph node dissection (PLND)
  • Patients with a history of radiotherapy for prostate cancer
  • Any other patients whom the principal investigator or a co-investigator deem inappropriate, such as those with missing outcome data.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Ichinomiyanishi Hospital

Ichinomiya, Aichi-ken, 494-0001, Japan

Location

Fujita Health University Hospital

Toyoake, Aichi-ken, 470-1192, Japan

Location

Saiseikai Yokohamashi Tobu Hospital

Yokohama, Kanagawa, 230-0012, Japan

Location

Kyoto City Hospital

Kyoto, Kyoto, 604-8845, Japan

Location

Mie University Hospital

Tsu, Mie-ken, 514-8507, Japan

Location

Ageo Central General Hospital

Ageo, Saitama, 362-8588, Japan

Location

National Cancer Center Hospital

Tokyo, Tokyo, 104-0045, Japan

Location

Tokyo Medical Center

Tokyo, Tokyo, 152-8902, Japan

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Masashi Takenaka

    Fujita Health University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 3, 2026

First Posted

June 24, 2026

Study Start

March 26, 2026

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

March 31, 2027

Last Updated

June 24, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations

JP(8)