MiProstate - Information Hub for the Prostate Cancer Care Flow

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05239377
• Other study ID #: MiProstate
• Status: Completed
• Start date: February 21, 2017
• Est. completion date: December 10, 2021

Study information

• Verified date: February 2022
• Source: Karolinska University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1329
• Est. completion date: December 10, 2021
• Est. primary completion date: June 1, 2021
• Gender: Male
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Other:
• IntelliSpace Precision Medicine Multidisciplinary Team Orchestrator
Digital decision support

Locations

Country	Name	City	State
Sweden	Karolinska University Hospital	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska University Hospital	Philips Electronics Nederland B.V. acting through Philips CTO organization

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)