Evaluation of a MRI-based Prostate Cancer Screening Program

Prostate Cancer Clinical Trial

— VISIONING  

Official title:

Evaluation of a MRI-based Prostate Cancer Screening Program

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03749993
• Other study ID #: VISIONING1
• Status: Completed
• Phase: N/A
• Start date: January 10, 2019
• Est. completion date: May 1, 2023

Study information

• Verified date: May 2023
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 241
• Est. completion date: May 1, 2023
• Est. primary completion date: April 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 46 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Other:
• Screening
Use of bpMRI for opportunistic prostate cancer screening.

Locations

Country	Name	City	State
Switzerland	University Hospital Basel, Clinic of Urology	Basel

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

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