Clinical trial NCT03749993: Evaluation of a MRI-based Prostate Cancer Screening Program
Official title: Evaluation of a MRI-based Prostate Cancer Screening Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2018-11-21
Enrollment: 241
Sex: MALE
Minimum age (years): 46
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

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.

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

Primary outcomes:
measure: Total costs of the MRI based prostate cancer screening
timeFrame: 24 months
Secondary outcomes:
measure: Comparison of costs of classical screening based on PSA and DRE
timeFrame: 24 months
measure: number of patients undergoing active surveillance
timeFrame: 24 months
measure: number of patients undergoing radical cystoprostatectomy
timeFrame: 24 months
measure: number of patients undergoing radiotherapy
timeFrame: 24 months
measure: number of patients undergoing androgen deprivation therapy
timeFrame: 24 months
measure: number of patients undergoing chemotherapy
timeFrame: 24 months
measure: Quality of Life (Qol)
timeFrame: 24 months
measure: Distress Thermometer Assessment
timeFrame: 24 months
measure: AI Evaluation
timeFrame: 24 months
measure: Number of patients
timeFrame: 24 months
measure: Number of consultations
timeFrame: 24 months
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital Basel, Clinic of Urology
Study officials:
affiliation: University Hospital, Basel, Switzerland
name: Cyrill Rentsch, MD PHD
role: PRINCIPAL_INVESTIGATOR
References: