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Completed

NCT Number: NCT03749993

Evaluation of a MRI-based Prostate Cancer Screening Program

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.

Completed

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Key information

Age range

46 year–75 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Basel, Clinic of Urology

Basel, 4031, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Screening

Other

Use of bpMRI for opportunistic prostate cancer screening.

Primary outcomes

  1. Total costs of the MRI based prostate cancer screening

    Time frame: 24 months

    Total costs of the program

Secondary outcomes

  1. Comparison of costs of classical screening based on PSA and DRE

    Time frame: 24 months

    Total costs per patient

  2. number of patients undergoing active surveillance

    Time frame: 24 months

    Number of follow-up interventions

  3. number of patients undergoing radical cystoprostatectomy

    Time frame: 24 months

    Number of follow-up interventions

  4. number of patients undergoing radiotherapy

    Time frame: 24 months

    Number of follow-up interventions

  5. number of patients undergoing androgen deprivation therapy

    Time frame: 24 months

    Number of follow-up interventions

  6. number of patients undergoing chemotherapy

    Time frame: 24 months

    Number of follow-up interventions

  7. Quality of Life (Qol)

    Time frame: 24 months

    Qol Questionnaire (SF- 36) score (0-100), 0 means best, 100 worst case

  8. Distress Thermometer Assessment

    Time frame: 24 months

    "Distress Thermometer" score (0-10)

  9. AI Evaluation

    Time frame: 24 months

    Evaluation of algorithms (AI) for CAD MRI based PCA diagnostic

  10. Number of patients

    Time frame: 24 months

    Number of patients needed to screen

  11. Number of consultations

    Time frame: 24 months

    Number of total consultations

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Acronym: VISIONING

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Nov 21, 2018
Registry last updated
May 23, 2023

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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