Prostate Cancer
Conditions
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.
Interventions
OTHERIntelliSpace Precision Medicine Multidisciplinary Team Orchestrator
Digital decision support
Sponsors
Philips Electronics Nederland B.V. acting through Philips CTO organization
Karolinska University Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Inclusion criteria
* All patients planned for prostatectomy and discussed at pre-operative conference at Karolinska University Hospital
Exclusion criteria
\-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 |
| 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 |
| 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). |
| 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. |
Countries
Sweden
Outcome results
None listed