MiProstate - Information Hub for the Prostate Cancer Care Flow

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Prostate Cancer

Intervention / Treatment
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* Other: IntelliSpace Precision Medicine Multidisciplinary Team Orchestrator


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients planned for prostatectomy and discussed at pre-operative conference at Karolinska University Hospital Exclusion Criteria: -
Sexes Eligible for Study
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Male

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Baseline<br>Pre-prostatectomy conferences conducted without the use of digital support | |
| ISPM -MiProstate<br>Pre-prostatectomy conferences conducted with the use of digital support (ISPM- MiProstate) | Other: IntelliSpace Precision Medicine Multidisciplinary Team Orchestrator<br>* Digital decision support<br>|

What is the study measuring?
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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) |