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

University Hospital Basel

Status: Completed

Conditions: Prostate Cancer

Treatments: Other: Screening

Study type: Interventional

Funder types: Other

Identifiers

NCT03749993

VISIONING1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 241 patients

Sex: Male

Ages: 46 to 75 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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241 participants in 1 patient group

Screening Arm

Other group

Description:

Screening

Treatment:

Other: Screening