MiProstate - Information Hub for the Prostate Cancer Care Flow

Clinical Evaluation of the Benefits of the MiProstate Platform: Follow-up Study

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.

Study Overview

• Status: Completed
• Conditions: Prostate Cancer
• Intervention / Treatment: Other: IntelliSpace Precision Medicine Multidisciplinary Team Orchestrator

Detailed Description

In the study cohort, all clinically relevant data on patients undergoing radical prostatectomy at Karolinska University Hospital were registered on the platform and subsequently presented using the platform at the conferences in which a detailed treatment plan was devised for each patient.

• Study Type: Observational
• Enrollment (Actual): 1329

Contacts and Locations

Study Locations

• Sweden
  • Stockholm, Sweden, SE 171 76
    • Karolinska University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

-

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Digital decision support

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
PSM - positive surgical margin	Percent of patients with positive surgical margins (an indication of non-radical surgical treatment) as assessed by uro-pathologists	At surgery. Reported within 30 days after surgery
PROM1 - patient-reported outcome measure on urinary function	Patient-reported sequelae with respect to urinary function. The Swedish national prostate cancer PROM questionnaire is used. Urinary incontinence is defined as reporting use of one or more protective pads per day.	At 12 months post surgery (11-18 months is tolerated)
PROM2 -patient-reported outcome measure on erectile function	Patient-reported sequelae with respect to erectile function. The Swedish national prostate cancer PROM questionnaire is used. Erectile dysfunction is defined as IIEF-5 score<12.	At 12 months post surgery (11-18 months is tolerated)
Nerve-sparing strategy	The nerve-sparing (ns) strategy chosen is reported, specifically percent of patients for which non-ns, uni-lateral or bi-lateral ns procedures are chosen, respectively. Furthermore, the chosen side-specific surgical distance to the prostate is reported as percent intra-fascial ns, inter-fascial ns, semi-ns and non-ns respectively (in increasing order of distance from the prostate capsule).	Recorded at pre-operative conference (<30 days prior to surgery)
PLND - pelvic lymph node dissection strategy	The frequency of patients for which a decision is made at the pre-operative conference to remove the pelvic lymph nodes (yes/no) is reported	Recorded at pre-operative conference (<30 days prior to surgery)

Collaborators and Investigators

• Sponsor: Karolinska University Hospital
• Collaborators: Philips Electronics Nederland B.V. acting through Philips CTO organization
• Investigators: Principal Investigator: Olof Akre, MD,Professor, Karolinska University Hospital, Dept of Pelvic Cancer

Study record dates

Study Major Dates

• Study Start (Actual): February 21, 2017
• Primary Completion (Actual): June 1, 2021
• Study Completion (Actual): December 10, 2021

Study Registration Dates

• First Submitted: January 10, 2022
• First Submitted That Met QC Criteria: February 3, 2022
• First Posted (Actual): February 14, 2022

Study Record Updates

• Last Update Posted (Actual): February 14, 2022
• Last Update Submitted That Met QC Criteria: February 3, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: MiProstate

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No