MiProstate - Information Hub for the Prostate Cancer Care Flow

Completed

• Conditions: Prostate Cancer
• Interventions: Other: IntelliSpace Precision Medicine Multidisciplinary Team Orchestrator

• Registration Number: NCT05239377
• Lead Sponsor: Karolinska University Hospital

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.

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 Timeline

• Study Start: 2017-02-21
• Primary Completion: 2021-06-01
• Study Completion: 2021-12-10
• Study First Submitted: 2022-01-10
• Status Verified: 2022-02
• Study First Submitted QC: 2022-02-03
• Last Update Submitted: 2022-02-03
• Study First Posted: 2022-02-14
• Last Update Posted: 2022-02-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 1329

Inclusion Criteria

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

Exclusion Criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ISPM -MiProstate	IntelliSpace Precision Medicine Multidisciplinary Team Orchestrator	Pre-prostatectomy conferences conducted with the use of digital support (ISPM- MiProstate)

Primary Outcome Measures

Name	Time	Method
Pre-operative conference quality	Recorded at pre-operative conference held <30 days prior to surgery	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.
Efficiency - time spent in pre-operative conference	Recorded at pre-operative conference held <30 days prior to surgery	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.

Secondary Outcome Measures

Name	Time	Method
PROM1 - patient-reported outcome measure on urinary function	At 12 months post surgery (11-18 months is tolerated)	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.
PLND - pelvic lymph node dissection strategy	Recorded at pre-operative conference (<30 days prior to surgery)	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
PSM - positive surgical margin	At surgery. Reported within 30 days after surgery	Percent of patients with positive surgical margins (an indication of non-radical surgical treatment) as assessed by uro-pathologists
PROM2 -patient-reported outcome measure on erectile function	At 12 months post surgery (11-18 months is tolerated)	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.
Nerve-sparing strategy	Recorded at pre-operative conference (<30 days prior to surgery)	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).

Trial Locations

Locations (1)

Karolinska University Hospital; 🇸🇪 Stockholm, Sweden