NCT05960669

Brief Summary

To optimize precision for secondary resection (SR) in frozen section (FS) controlled nerve-sparing robot-assisted radical prostatectomy (NS-RARP) by using a personalized 3D-printed prostate model.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable prostate-cancer

Timeline
Completed

Started Aug 2018

Typical duration for not_applicable prostate-cancer

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

August 1, 2018

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 26, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 26, 2022

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

July 17, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 27, 2023

Completed
Last Updated

July 27, 2023

Status Verified

July 1, 2023

Enrollment Period

3.1 years

First QC Date

July 17, 2023

Last Update Submit

July 17, 2023

Conditions

Prostate Cancer

Keywords

prostatectomynerve sparing3D modelurologyfrozen section

Outcome Measures

Primary Outcomes (1)

  • comparison of the primary surgical margin status in the FS with the tissue of the resulting SR and with the final surgical margin status

    4 weeks

Secondary Outcomes (2)

  • Erectile function

    1 year

  • Oncologic follow-up

    1 year

Study Arms (1)

3D model guided SR

EXPERIMENTAL

A prostate model was 3D printed from preoperative pelvic MRI data and used during surgery to mark a positive surgical margin and guide secondary resection.

Procedure: 3D model guided secondary resection

Interventions

3D model guided secondary resectionPROCEDURE

A prostate model was 3D printed from preoperative pelvic MRI data and used during robot-assisted radical prostatectomy to mark a positive surgical margin and guide secondary resection.

3D model guided SR

Eligibility Criteria

Age18 Years - 80 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • preoperatively planed and intraoperatively performed nerve-sparing approach (at least unilateral)
  • suitable pelvic MRI for the creation of a personalized 3D prostate model,
  • written patient consent

You may not qualify if:

  • no nerve sparing performed

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitätsspital Basel Urologie

Basel, 4031, Switzerland

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

  • Christian CE Engesser, Dr.

    University Hospital, Basel, Switzerland

    PRINCIPAL INVESTIGATOR

  • Jan JE Ebbing, PD Dr. med

    University Hospital, Basel, Switzerland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Cohort Study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 17, 2023

First Posted

July 27, 2023

Study Start

August 1, 2018

Primary Completion

August 26, 2021

Study Completion

August 26, 2022

Last Updated

July 27, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)