A Randomized Trial of Early Detection of Clinically Significant Prostate Cancer (ProScreen) (ProScreen)
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|ClinicalTrials.gov Identifier: NCT03423303|
Recruitment Status : Enrolling by invitation
First Posted : February 6, 2018
Last Update Posted : December 9, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Diagnostic Test: Prostate cancer screening||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||17400 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Of the approximately 117,200 men aged 50-63 years resident in Helsinki and Tampere regions, a fourth will be randomised to screening and the rest to control arm (after exclusion of prevalent cases).|
|Masking:||None (Open Label)|
|Official Title:||Prostate Cancer Screening Trial|
|Actual Study Start Date :||April 23, 2018|
|Estimated Primary Completion Date :||December 31, 2032|
|Estimated Study Completion Date :||December 31, 2032|
Experimental: Screening arm
Invitation to prostate cancer screening and questionnaires.
Diagnostic Test: Prostate cancer screening
Depending on each diagnostic test result the participants in the screening arm will undergo PSA-testing, 4Kscore determination, MRI, and MRI/US fusion biopsy only.
No Intervention: Control arm
Registry-based follow-up and a questionnaire.
- Prostate cancer (PrCa) mortality [ Time Frame: At 10 years of follow-up. ]An intention to screen analysis will be performed, with all men in the groups defined by random allocation, regardless of compliance. Follow-up starts at randomisation, and ends at death. Cox regression will be used with prostate cancer death as the outcome.
- Prostate cancer (PrCa) mortality - secondary analysis [ Time Frame: At 10 years of follow-up. ]A secondary analysis of prostate cancer mortality will be performed using the Cuzick method with correction for contamination and selection bias due to non-compliance.
- Cumulative incidence of advanced (T3-T4 or M1) prostate cancer [ Time Frame: At approximately 5 years of follow-up. ]Intermediate outcomes include cumulative incidence of advanced (T3-T4 or M1) prostate cancer (number of cases relative to population size, not using incidence density to avoid the lead-time bias due to early detection by screening).
- Cumulative incidence of low-risk cancer (Gleason<7) [ Time Frame: At approximately 5 years of follow-up. ]Intermediate outcomes include cumulative incidence of low-risk cancer (Gleason<7) as an indicator of overdiagnosis.
- Analysis of screening test performance - 4Kscore [ Time Frame: At 2, 4, and 6 years. ]Diagnostic performance of 4Kscore among men with PSA>3 in terms of predictive values, sensitivity, and specificity for clinically significant PrCa (defined as Gleason 7+ cancers - including those diagnosed within the next four years for test-negative non-biopsied men i.e. false negatives).
- Analysis of screening test performance - MRI [ Time Frame: At 2, 4, and 6 years. ]Diagnostic performance of MRI based on PI-RADS v2 scores among men with PSA>3 and positive 4Kscore in terms of predictive values, sensitivity, and specificity for clinically significant PrCa (defined as Gleason 7+ cancers - including those diagnosed within the next four years for test-negative non-biopsied men i.e. false negatives).
- Assessment of health-related quality of life in men with prostate cancer [ Time Frame: At 4 years. ]Health-related quality of life among men diagnosed with prostate cancer will be assessed using the EPIC 26 instrument enrolling screen-detected and interval cases, as well as those diagnosed among non-participants and in the control arm.
- Assessment of short-term prostate cancer (PrCa)-specific anxiety [ Time Frame: At 4 years. ]Anxiety among men diagnosed with prostate cancer will be assessed using the Memorial Anxiety Scale for Prostate Cancer (MAX-PC), enrolling screen-detected and interval cases, as well as those diagnosed among non-participants and in the control arm.
- Adverse effects of prostate biopsy immediately after the biopsy [ Time Frame: During the first year. ]Adverse effects of biopsy are evaluated using a questionnaire on complications including assessment of bleeding, lower urinary tract symptoms (LUTS), erectile dysfunction (ED), pain, and antibiotic treatment immediately after the biopsy.
- Adverse effects of prostate biopsy 30 days after the biopsy [ Time Frame: During the first year. ]Adverse effects of biopsy are evaluated with a questionnaire on complications, including assessment of bleeding, lower urinary tract symptoms (LUTS), erectile dysfunction (ED), pain, and antibiotic treatment 30 days after the biopsy.
- Cost analysis (incremental cost effectiveness ratio) [ Time Frame: At 5 (cost analysis) and 10-15 (final analysis) years of follow-up. ]Economic evaluation will commence with cost analysis, and the final analysis of incremental cost effectiveness ratio (with a decision analysis) will be conducted once data on both long-term cost and real outcome data on both utilities (quality-adjusted life-years) and mortality are available.
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|Ages Eligible for Study:||50 Years to 63 Years (Adult)|
|Sexes Eligible for Study:||Male|
|Gender Based Eligibility:||Yes|
|Gender Eligibility Description:||Trial participants will be identified by the Finnish Population Register Centre.|
|Accepts Healthy Volunteers:||Yes|
- 50-63-year-old men (age in 2018) residing in Tampere or Helsinki
- Prevalent prostate cancer
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03423303
|Helsinki University and Helsinki University Hospital|
|University of Tampere|
|Principal Investigator:||Anssi Auvinen, MD, PhD||Tampere University|
Documents provided by Anssi Auvinen, Tampere University:
|Responsible Party:||Anssi Auvinen, Professor, Tampere University|
|Other Study ID Numbers:||
|First Posted:||February 6, 2018 Key Record Dates|
|Last Update Posted:||December 9, 2022|
|Last Verified:||December 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Yes|
|Plan Description:||The data will be managed and made openly available with Finnish Social Science Data Archive (FSD) and publisher websites. The type of data includes numerical data, mainly counts, and continuous variables classified as categorical. The data will be uploaded in tabular form (as a data matrix). The data will be deidentified and supplied only as frequencies. The released data will be available under CC license for research purposes (accessible for registered users of FSD database). Citation of the original research is needed whenever used by third parties.|
Informed Consent Form (ICF)
|Time Frame:||The data wil be released after publication of the results (approximately 2032-).|
|Access Criteria:||CC license, FSD database registered users|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Magnetic resonance imaging
Genital Neoplasms, Male
Neoplasms by Site
Genital Diseases, Male
Male Urogenital Diseases