MiProstate - Information Hub for the Prostate Cancer Care Flow

NCT05239377 | Completed

• 1 other identifier: MiProstate
• Study Type: observational
• Target: 1,329
• Locations: 1 country
• Sites: 1

Brief Summary

This is an observational cohort study with a non-concurrent comparison group evaluating the use of a digital decision support tool (MiProstate/ISPM) at pre-prostatectomy, multidisciplinary conferences.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (2)

• Efficiency - time spent in pre-operative conference

  Time spent per patient in pre-operative, multidisciplinary conference, measured by an external observer. After prostate cancer diagnosis, work-up, and the decision to offer the patient surgical treatment with curative intent, a conference is held in which surgical strategies are discussed.

  Recorded at pre-operative conference held <30 days prior to surgery

• Pre-operative conference quality

  Quality of pre-operative conference as measured by MDT-MODe (MultiDisciplinary Therapy conference - Metric Of Decision Making) score assigned by an external observer. After prostate cancer diagnosis, work-up, and the decision to offer the patient surgical treatment with curative intent, a conference is held in which surgical strategies are discussed.

  Recorded at pre-operative conference held <30 days prior to surgery

Secondary Outcomes (5)

• PSM - positive surgical margin

  At surgery. Reported within 30 days after surgery

• PROM1 - patient-reported outcome measure on urinary function

  At 12 months post surgery (11-18 months is tolerated)

• PROM2 -patient-reported outcome measure on erectile function

  At 12 months post surgery (11-18 months is tolerated)

• Nerve-sparing strategy

  Recorded at pre-operative conference (<30 days prior to surgery)

• PLND - pelvic lymph node dissection strategy

  Recorded at pre-operative conference (<30 days prior to surgery)

Study Arms (2)

Baseline

Pre-prostatectomy conferences conducted without the use of digital support

ISPM -MiProstate

Pre-prostatectomy conferences conducted with the use of digital support (ISPM- MiProstate)

Other: IntelliSpace Precision Medicine Multidisciplinary Team Orchestrator

Interventions

IntelliSpace Precision Medicine Multidisciplinary Team Orchestrator OTHER

Digital decision support

ISPM -MiProstate

Eligibility Criteria

• Sex: male
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Prostate cancer patients at Karolinska University Hospital in the time period Feb 2017- Mar 2019

You may qualify if:

• All patients planned for prostatectomy and discussed at pre-operative conference at Karolinska University Hospital

Sponsors & Collaborators

• Karolinska University Hospital: lead
• Philips Electronics Nederland B.V. acting through Philips CTO organization: collaborator

Study Sites (1)

Karolinska University Hospital

Stockholm, SE 171 76, Sweden

Location

MeSH Terms

Conditions

Prostatic 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

Study Officials

• Olof Akre, MD,Professor

  Karolinska University Hospital, Dept of Pelvic Cancer

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: January 10, 2022
• First Posted: February 14, 2022
• Study Start: February 21, 2017
• Primary Completion: June 1, 2021
• Study Completion: December 10, 2021
• Last Updated: February 14, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)