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Evaluation of a MRI-based Prostate Cancer Screening Program (VISIONING)

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Screening
Sponsored by
University Hospital, Basel, Switzerland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Prostate Cancer

Eligibility Criteria

46 Years - 75 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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:

  • 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

Sites / Locations

  • University Hospital Basel, Clinic of Urology

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Screening Arm

Arm Description

Screening

Outcomes

Primary Outcome Measures

Total costs of the MRI based prostate cancer screening
Total costs of the program

Secondary Outcome Measures

Comparison of costs of classical screening based on PSA and DRE
Total costs per patient
number of patients undergoing active surveillance
Number of follow-up interventions
number of patients undergoing radical cystoprostatectomy
Number of follow-up interventions
number of patients undergoing radiotherapy
Number of follow-up interventions
number of patients undergoing androgen deprivation therapy
Number of follow-up interventions
number of patients undergoing chemotherapy
Number of follow-up interventions
Quality of Life (Qol)
Qol Questionnaire (SF- 36) score (0-100), 0 means best, 100 worst case
Distress Thermometer Assessment
"Distress Thermometer" score (0-10)
AI Evaluation
Evaluation of algorithms (AI) for CAD MRI based PCA diagnostic
Number of patients
Number of patients needed to screen
Number of consultations
Number of total consultations

Full Information

First Posted
September 24, 2018
Last Updated
May 22, 2023
Sponsor
University Hospital, Basel, Switzerland
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1. Study Identification

Unique Protocol Identification Number
NCT03749993
Brief Title
Evaluation of a MRI-based Prostate Cancer Screening Program
Acronym
VISIONING
Official Title
Evaluation of a MRI-based Prostate Cancer Screening Program
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
January 10, 2019 (Actual)
Primary Completion Date
April 1, 2023 (Actual)
Study Completion Date
May 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Basel, Switzerland

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
241 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Screening Arm
Arm Type
Other
Arm Description
Screening
Intervention Type
Other
Intervention Name(s)
Screening
Intervention Description
Use of bpMRI for opportunistic prostate cancer screening.
Primary Outcome Measure Information:
Title
Total costs of the MRI based prostate cancer screening
Description
Total costs of the program
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Comparison of costs of classical screening based on PSA and DRE
Description
Total costs per patient
Time Frame
24 months
Title
number of patients undergoing active surveillance
Description
Number of follow-up interventions
Time Frame
24 months
Title
number of patients undergoing radical cystoprostatectomy
Description
Number of follow-up interventions
Time Frame
24 months
Title
number of patients undergoing radiotherapy
Description
Number of follow-up interventions
Time Frame
24 months
Title
number of patients undergoing androgen deprivation therapy
Description
Number of follow-up interventions
Time Frame
24 months
Title
number of patients undergoing chemotherapy
Description
Number of follow-up interventions
Time Frame
24 months
Title
Quality of Life (Qol)
Description
Qol Questionnaire (SF- 36) score (0-100), 0 means best, 100 worst case
Time Frame
24 months
Title
Distress Thermometer Assessment
Description
"Distress Thermometer" score (0-10)
Time Frame
24 months
Title
AI Evaluation
Description
Evaluation of algorithms (AI) for CAD MRI based PCA diagnostic
Time Frame
24 months
Title
Number of patients
Description
Number of patients needed to screen
Time Frame
24 months
Title
Number of consultations
Description
Number of total consultations
Time Frame
24 months

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
Informed men at risk for prostate cancer will be included into the study to undergo prostate cancer screening.
Minimum Age & Unit of Time
46 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cyrill Rentsch, MD PHD
Organizational Affiliation
University Hospital, Basel, Switzerland
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Basel, Clinic of Urology
City
Basel
ZIP/Postal Code
4031
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No

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Evaluation of a MRI-based Prostate Cancer Screening Program

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