Prostate CancerNCT05239377
MiProstate - Information Hub for the Prostate Cancer Care Flow
An observational study of Prostate Cancer, run by Karolinska University Hospital at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- IntelliSpace Precision Medicine Multidisciplinary Team Orchestrator
- How many people
- 1,329 participants
- Where
- 1 siteSweden
- Study dates
- 21 Feb 2017to 10 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- Child, Adult, Older adult
Study population: Prostate cancer patients at Karolinska University Hospital in the time period Feb 2017- Mar 2019
Who may be able to join
- All patients planned for prostatectomy and discussed at pre-operative conference at Karolinska University Hospital
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Evaluation of the Benefits of the MiProstate Platform: Follow-up Study
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.
Read the 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.
- Conditions
- Prostate Cancer
- Being tested
- IntelliSpace Precision Medicine Multidisciplinary Team Orchestrator
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IntelliSpace Precision Medicine Multidisciplinary Team OrchestratorOther
Digital decision support
| Study group | Role | What they receive |
|---|---|---|
| Baseline | Pre-prostatectomy conferences conducted without the use of digital support | |
| ISPM -MiProstate | Pre-prostatectomy conferences conducted with the use of digital support (ISPM- MiProstate) Receives: Other: IntelliSpace Precision Medicine Multidisciplinary Team Orchestrator |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Recorded at pre-operative conference held <30 days prior to surgery
Secondary outcomes (5)
PSM - positive surgical margin
Percent of patients with positive surgical margins (an indication of non-radical surgical treatment) as assessed by uro-pathologists
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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
Measured: Recorded at pre-operative conference (<30 days prior to surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2022
- Study start21 Feb 2017
- Primary completion1 Jun 2021
- Study completion10 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Karolinska University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,329 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Philips Clinical & Medical Affairs Global
- Responsible party
- Principal investigator, Olof Akre, Karolinska University Hospital
- Investigators
- Olof Akre, MD,Professor, Principal investigator, Karolinska University Hospital, Dept of Pelvic Cancer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05239377
- Sponsor's protocol ID
- MiProstate
- Status last verified
- Feb 2022
- First submitted
- 10 Jan 2022
- Last updated
- 14 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of the Benefits of the MiProstate Platform: Follow-up Study
- ClinicalTrials.gov ID
- NCT05239377
- Acronym / sponsor ID
- MiProstate
- Conditions
- Prostate Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,329 participants (actual)
- Lead sponsor
- Karolinska University HospitalUniversity, hospital or other
- Collaborators
- Philips Clinical & Medical Affairs Global
- Study start
- 21 Feb 2017 (actual)
- Primary completion
- 1 Jun 2021 (actual)
- Study completion
- 10 Dec 2021 (actual)
- First posted
- 14 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Baseline | – | –Pre-prostatectomy conferences conducted without the use of digital support |
| ISPM -MiProstate | – | Other: IntelliSpace Precision Medicine Multidisciplinary Team OrchestratorPre-prostatectomy conferences conducted with the use of digital support (ISPM- MiProstate) |
Who may qualify
- Sex
- Male only
- Age groups
- Child, Adult, Older adult
- Study population
- Prostate cancer patients at Karolinska University Hospital in the time period Feb 2017- Mar 2019
Key inclusion criteria (1 listed)
- All patients planned for prostatectomy and discussed at pre-operative conference at Karolinska University Hospital
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IntelliSpace Precision Medicine Multidisciplinary Team OrchestratorDigital decision support | Other | ISPM -MiProstate |
Primary outcome
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.
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.
5 secondary outcomes
PSM - positive surgical margin
Time frame: At surgery. Reported within 30 days after surgery
PROM1 - patient-reported outcome measure on urinary function
Time frame: At 12 months post surgery (11-18 months is tolerated)
PROM2 -patient-reported outcome measure on erectile function
Time frame: At 12 months post surgery (11-18 months is tolerated)
Nerve-sparing strategy
Time frame: Recorded at pre-operative conference (<30 days prior to surgery)
PLND - pelvic lymph node dissection strategy
Time frame: Recorded at pre-operative conference (<30 days prior to surgery)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olof Akre, MD,Professor principal investigator
Karolinska University Hospital, Dept of Pelvic Cancer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by Karolinska University Hospital at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficiency - time spent in pre-operative conference (time frame: Recorded at pre-operative conference held <30 days prior to surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2022.