Evaluation of a MRI-based Prostate Cancer Screening Program

Not Applicable

Completed

• Conditions: Prostate Cancer
• Interventions: Other: Screening

• Registration Number: NCT03749993
• Lead Sponsor: University Hospital, Basel, Switzerland

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.

Study Timeline

• Study First Submitted: 2018-09-24
• Study First Submitted QC: 2018-11-19
• Study First Posted: 2018-11-21
• Study Start: 2019-01-10
• Primary Completion: 2023-04-01
• Status Verified: 2023-05
• Study Completion: 2023-05-01
• Last Update Submitted: 2023-05-22
• Last Update Posted: 2023-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 241

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Screening Arm	Screening	Screening

Primary Outcome Measures

Name	Time	Method
Total costs of the MRI based prostate cancer screening	24 months	Total costs of the program

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University Hospital Basel, Clinic of Urology; 🇨🇭 Basel, Switzerland