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NCT Number: NCT05239377

MiProstate - Information Hub for the Prostate Cancer Care Flow

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Sex eligibility

Male

Study type

Observational

Primary location

Karolinska University Hospital

Stockholm, SE 171 76, Sweden

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

-

Treatment and study plan

IntelliSpace Precision Medicine Multidisciplinary Team Orchestrator

Other

Digital decision support

Primary outcomes

  1. Efficiency - time spent in pre-operative conference

    Time frame: 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.

  2. Pre-operative conference quality

    Time frame: 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 outcomes

  1. PSM - positive surgical margin

    Time frame: 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

  2. PROM1 - patient-reported outcome measure on urinary function

    Time frame: 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.

  3. PROM2 -patient-reported outcome measure on erectile function

    Time frame: 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.

  4. Nerve-sparing strategy

    Time frame: 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).

  5. PLND - pelvic lymph node dissection strategy

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Karolinska University Hospital

Other

Collaborators

  • Philips Electronics Nederland B.V. acting through Philips CTO organization

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Feb 14, 2022
Registry last updated
Feb 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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