NCT03749993

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
241

participants targeted

Target at P75+ for not_applicable prostate-cancer

Timeline
Completed

Started Jan 2019

Typical duration for not_applicable prostate-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 24, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 21, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

January 10, 2019

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2023

Completed
Last Updated

May 23, 2023

Status Verified

May 1, 2023

Enrollment Period

4.2 years

First QC Date

September 24, 2018

Last Update Submit

May 22, 2023

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

  • Total costs of the MRI based prostate cancer screening

    Total costs of the program

    24 months

Secondary Outcomes (11)

  • Comparison of costs of classical screening based on PSA and DRE

    24 months

  • number of patients undergoing active surveillance

    24 months

  • number of patients undergoing radical cystoprostatectomy

    24 months

  • number of patients undergoing radiotherapy

    24 months

  • number of patients undergoing androgen deprivation therapy

    24 months

  • +6 more secondary outcomes

Study Arms (1)

Screening Arm

OTHER

Screening

Other: Screening

Interventions

ScreeningOTHER

Use of bpMRI for opportunistic prostate cancer screening.

Screening Arm

Eligibility Criteria

Age46 Years - 75 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsInformed men at risk for prostate cancer will be included into the study to undergo prostate cancer screening.
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Basel, Clinic of Urology

Basel, 4031, Switzerland

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Mass Screening

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and ProceduresDiagnosisHealth SurveysSurveys and QuestionnairesData CollectionEpidemiologic MethodsInvestigative TechniquesDiagnostic ServicesPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public HealthPublic Health Practice

Study Officials

  • Cyrill Rentsch, MD PHD

    University Hospital, Basel, Switzerland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 24, 2018

First Posted

November 21, 2018

Study Start

January 10, 2019

Primary Completion

April 1, 2023

Study Completion

May 1, 2023

Last Updated

May 23, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)