Prostate CancerVISIONINGNCT03749993
Evaluation of a MRI-based Prostate Cancer Screening Program
A study testing Screening in people with Prostate Cancer, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
The purpose of this study is to evaluate the effort and resources (incl. costs) required to detect 20 clinically relevant prostate cancer (PCA) in a screening program based on bpMRI of the prostate. Read more about this study
- Who is it for?
- Ages 46 to 75 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Screening
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 241 participants
- Where
- 1 siteSwitzerland
- Study dates
- 10 Jan 2019to 1 May 2023
- Phase
- Interventional
- 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 46 to 75 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- well-informed men with the wish for prostate cancer screening
- prostate biopsy naïve
- life expectancy > 10 years
- men > 50 years of age
- men > 45 years of age with a family history of prostate cancer
- African-Americans > 45 years of age
Who cannot join
- prostate biopsy performed prior to study
- life expectancy < 10 years
- acute urinary tract infection
- NIH-CPSI score 19 (leads to initiation of urologic diagnostics and treatment)
- IPSS score 20 (leads to initiation of urologic diagnostics and treatment)
- Contraindications for MRI:
Show all 12Show fewer
- Heart pacemaker
- Artificial heart valves (some types are eligible)
- Cochlea implant
- ICD
- Metallic foreign bodies/devices/implants (neuro-stimulator, pain or insulin pump, etc.)
- Severe claustrophobia
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Basel, Clinic of Urology
Basel, 4031
About this study
The purpose of this study is to evaluate the effort and resources (incl. costs) required to detect 20 clinically relevant prostate cancer (PCA) in a screening program based on bpMRI of the prostate.
Read the detailed description
Informed men at risk for prostate cancer will be included into the study to undergo prostate cancer screening. According to European guidelines we will include men > 50 years of age and men >45 years of age and a family history of PCA as well as African-Americans >45 years of age. In this study, bpMRI will be used for opportunistic prostate cancer screening.
The indication for prostate biopsy is based solely on the results of bpMRI. In case of detection of lesions suspicious for prostate cancer ( PIRADS 3), targeted MRI-TRUS fusion biopsy with 3 biopsies per lesion will be performed. In case no lesions suspicious for PCA ( PIRADS 3) are detected, SB will performed if PSA exceeds 10ng/ml and/or DRE is suspicious for PCA.
- Conditions
- Prostate Cancer
- Being tested
- Screening
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ScreeningOther
Use of bpMRI for opportunistic prostate cancer screening.
| Study group | Role | What they receive |
|---|---|---|
| Screening Arm | Other | Screening Receives: Other: Screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total costs of the MRI based prostate cancer screening
Total costs of the program
Measured: 24 months
Secondary outcomes (11)
Comparison of costs of classical screening based on PSA and DRE
Total costs per patient
Measured: 24 months
number of patients undergoing active surveillance
Number of follow-up interventions
Measured: 24 months
number of patients undergoing radical cystoprostatectomy
Number of follow-up interventions
Measured: 24 months
number of patients undergoing radiotherapy
Number of follow-up interventions
Measured: 24 months
number of patients undergoing androgen deprivation therapy
Number of follow-up interventions
Measured: 24 months
number of patients undergoing chemotherapy
Number of follow-up interventions
Measured: 24 months
Quality of Life (Qol)
Qol Questionnaire (SF- 36) score (0-100), 0 means best, 100 worst case
Measured: 24 months
Distress Thermometer Assessment
"Distress Thermometer" score (0-10)
Measured: 24 months
AI Evaluation
Evaluation of algorithms (AI) for CAD MRI based PCA diagnostic
Measured: 24 months
Number of patients
Number of patients needed to screen
Measured: 24 months
Number of consultations
Number of total consultations
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2018
- Study start10 Jan 2019
- Primary completion1 Apr 2023
- Study completion1 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 241 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cyrill Rentsch, MD PHD, Principal investigator, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03749993
- Sponsor's protocol ID
- VISIONING1
- Acronym
- VISIONING
- Status last verified
- May 2023
- First submitted
- 24 Sep 2018
- Last updated
- 23 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wetterauer C, Matthias M, Pueschel H, Deckart A, Bubendorf L, Mortezavi A, Arbelaez E, Jean Winkel D, Heye T, Boll DT, Merkle E, Hayoz S, Seifert HH, Rentsch CA. Opportunistic Prostate Cancer Screening with Biparametric Magnetic Resonance Imaging (VISIONING). Eur Urol Focus. 2024 Mar;10(2):332-338. doi: 10.1016/j.euf.2024.02.006. Epub 2024 Feb 23.
PubMed 38402105
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a MRI-based Prostate Cancer Screening Program
- ClinicalTrials.gov ID
- NCT03749993
- Acronym / sponsor ID
- VISIONING / VISIONING1
- Conditions
- Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 241 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 10 Jan 2019 (actual)
- Primary completion
- 1 Apr 2023 (actual)
- Study completion
- 1 May 2023 (actual)
- First posted
- 21 Nov 2018 (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.
The purpose of this study is to evaluate the effort and resources (incl. costs) required to detect 20 clinically relevant prostate cancer (PCA) in a screening program based on bpMRI of the prostate.
Detailed description
Informed men at risk for prostate cancer will be included into the study to undergo prostate cancer screening. According to European guidelines we will include men > 50 years of age and men >45 years of age and a family history of PCA as well as African-Americans >45 years of age. In this study, bpMRI will be used for opportunistic prostate cancer screening.
The indication for prostate biopsy is based solely on the results of bpMRI. In case of detection of lesions suspicious for prostate cancer ( PIRADS 3), targeted MRI-TRUS fusion biopsy with 3 biopsies per lesion will be performed. In case no lesions suspicious for PCA ( PIRADS 3) are detected, SB will performed if PSA exceeds 10ng/ml and/or DRE is suspicious for PCA.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Screening Arm | Other | Other: ScreeningScreening |
Who may qualify
- Ages
- 46 to 75 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- well-informed men with the wish for prostate cancer screening
- prostate biopsy naïve
- life expectancy > 10 years
- men > 50 years of age
- men > 45 years of age with a family history of prostate cancer
Key exclusion criteria (12 listed)
- prostate biopsy performed prior to study
- life expectancy < 10 years
- acute urinary tract infection
- NIH-CPSI score 19 (leads to initiation of urologic diagnostics and treatment)
- IPSS score 20 (leads to initiation of urologic diagnostics and treatment)
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 |
|---|---|---|
| ScreeningUse of bpMRI for opportunistic prostate cancer screening. | Other | Screening Arm |
Primary outcome
Total costs of the MRI based prostate cancer screening
Time frame: 24 months
Total costs of the program
11 secondary outcomes
Comparison of costs of classical screening based on PSA and DRE
Time frame: 24 months
number of patients undergoing active surveillance
Time frame: 24 months
number of patients undergoing radical cystoprostatectomy
Time frame: 24 months
number of patients undergoing radiotherapy
Time frame: 24 months
number of patients undergoing androgen deprivation therapy
Time frame: 24 months
number of patients undergoing chemotherapy
Time frame: 24 months
Quality of Life (Qol)
Time frame: 24 months
Distress Thermometer Assessment
Time frame: 24 months
AI Evaluation
Time frame: 24 months
Number of patients
Time frame: 24 months
Number of consultations
Time frame: 24 months
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 23 May 2023.
- Derived from this study: PubMed 38402105Wetterauer C, Matthias M, Pueschel H, Deckart A, Bubendorf L, Mortezavi A, Arbelaez E, Jean Winkel D, Heye T, Boll DT, Merkle E, Hayoz S, Seifert HH, Rentsch CA. Opportunistic Prostate Cancer Screening with Biparametric Magnetic Resonance Imaging (VISIONING). Eur Urol Focus. 2024 Mar;10(2):332-338. doi: 10.1016/j.euf.2024.02.006. Epub 2024 Feb 23.
- 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.
Cyrill Rentsch, MD PHD principal investigator
University Hospital, Basel, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Screening in people with Prostate Cancer, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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 6 inclusion and 12 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 23 May 2023. 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 Switzerland. 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?
Total costs of the MRI based prostate cancer screening (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03749993, which also lists 1 linked publication.
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 23 May 2023.