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

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.

Study Overview

• Status: Completed
• Conditions: Prostate Cancer
• Intervention / Treatment: Other: Screening

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 Type: Interventional
• Enrollment (Actual): 241
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Basel, Switzerland, 4031
    • University Hospital Basel, Clinic of Urology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 46 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Screening Arm; Screening	Other: Screening; Use of bpMRI for opportunistic prostate cancer screening.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total costs of the MRI based prostate cancer screening	Total costs of the program	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of costs of classical screening based on PSA and DRE	Total costs per patient	24 months
number of patients undergoing active surveillance	Number of follow-up interventions	24 months
number of patients undergoing radical cystoprostatectomy	Number of follow-up interventions	24 months
number of patients undergoing radiotherapy	Number of follow-up interventions	24 months
number of patients undergoing androgen deprivation therapy	Number of follow-up interventions	24 months
number of patients undergoing chemotherapy	Number of follow-up interventions	24 months
Quality of Life (Qol)	Qol Questionnaire (SF- 36) score (0-100), 0 means best, 100 worst case	24 months
Distress Thermometer Assessment	"Distress Thermometer" score (0-10)	24 months
AI Evaluation	Evaluation of algorithms (AI) for CAD MRI based PCA diagnostic	24 months
Number of patients	Number of patients needed to screen	24 months
Number of consultations	Number of total consultations	24 months

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Investigators: Principal Investigator: Cyrill Rentsch, MD PHD, University Hospital, Basel, Switzerland

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2019
• Primary Completion (Actual): April 1, 2023
• Study Completion (Actual): May 1, 2023

Study Registration Dates

• First Submitted: September 24, 2018
• First Submitted That Met QC Criteria: November 19, 2018
• First Posted (Actual): November 21, 2018

Study Record Updates

• Last Update Posted (Actual): May 23, 2023
• Last Update Submitted That Met QC Criteria: May 22, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: VISIONING1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No