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Early and Accurate Detection of Prostate Cancer in General Practice

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ClinicalTrials.gov Identifier: NCT03431753
Recruitment Status : Recruiting
First Posted : February 13, 2018
Last Update Posted : February 13, 2018
Sponsor:
Collaborators:
Regional Hospital Holstebro
University of Aarhus
Central Denmark Region
Karolinska Institutet
Karolinska University Hospital
Information provided by (Responsible Party):
University of Aarhus ( Aarhus University Hospital )

Brief Summary:

Prostate cancer (PC) is the most common malignancy (4500 new cases/year) and the second leading cause of cancer-associated mortality (1200 deaths/year) among men in Denmark. PC is generally diagnosed on the basis of an elevated prostate specific antigen blood test followed by transrectal ultrasound (TRUS)-guided prostate biopsy.

This study aims to test early detection of PC in general practice, using the STHLM3 model with superior specificity and sensitivity for clinically significant PC, combined with multiparametric magnetic resonance imaging (mpMRI) of the prostate and MR guided biopsy.


Condition or disease Intervention/treatment Phase
Prostate Cancer Prostate Neoplasm Prostate Adenocarcinoma Diagnostic Test: PSA, STHLM3 and mpMRI for PC detection Not Applicable

Detailed Description:

While early stage PC can be cured by surgery or radiation therapy, advanced PC is incurable and associated with high morbidity and mortality. Early detection is critical to save lives, but many newly diagnosed PCs are in reality non-aggressive and will not affect the patient's life or health, even if left untreated. There is an urgent need to replace current clinical practice with a more accurate diagnostic approach that can ensure early detection of aggressive PC while curable, reduce unnecessary prostate biopsies incl. risk of sepsis and reduce overdiagnosis/-treatment of indolent PC.

New molecular biomarkers applied in general practice, serving as a pre-selection test for follow-up, and accurate and patient-friendly MR-imaging and MR-targeted biopsy at the hospital may help to solve these problems.

In this study the investigators will assess the clinical utility of combining genetic risk testing and plasma protein markers (STHLM3 test) in general practice with mpMRI and MR-guided in bore biopsy (MRGB) for early PC detection in a biopsy naïve population.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3000 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Early and Accurate Detection of Prostate Cancer in General Practice Using Novel Molecular Biomarkers and Multiparametric MR Imaging.
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: PSA, STHLM3 and mpMRI for PC detection
mpMRI, and if suspect MR-targeted prostate biopsy, in men with increased PC risk as judged from the STHLM3 test and/or an elevated prostate specific antigen test.
Diagnostic Test: PSA, STHLM3 and mpMRI for PC detection

Men who request a prostate specific antigen test from their general practitioner will be offered study participation.

Men with increased PC risk as judged from the STHLM3 test and/or an elevated PSA test will be offered an mpMRI examination.





Primary Outcome Measures :
  1. Proportion of PC suspicious lesions detected by mpMRI based on the STHLM3 test vs. the prostate specific antigen test. [ Time Frame: 24 months ]
    Evaluation of the proportion of patients identified with PC suspicious lesions at mpMRI based on the STHLM3 vs. the prostate specific antigen test.


Secondary Outcome Measures :
  1. Proportion of PC diagnoses detected in the study population based on the STHLM3 test vs. the prostate specific antigen test. [ Time Frame: 24 months ]
    Evaluation of the proportion of total PCs and clinically significant PCs diagnosed with MR guided biopsy as a function of the primary tests.

  2. Compare results from clinical study with current clinical practice. [ Time Frame: 24 months ]
    Comparison of the results from the clinical study with the number of prostate specific antigen tests, TRUS-biopsies, indolent and significant PCs detected by current clinical practice, using health register data from general practices not taking part in the trial.



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Ages Eligible for Study:   50 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • aged 50-69 years
  • no previous pelvic cancer
  • no previous prostate biopsy
  • no previous elevated PSA results
  • informed consent from the participant

Exclusion Criteria:

  • palpable prostatae tumor by digital rectal examination
  • previously diagnosed with/or treated for an urogenital cancer disease
  • contraindications to 3 T MRI
  • known severe renal impairment with estimated glomerular filtration rate <30 ml / min

Information from the National Library of Medicine

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): NCT03431753


Contacts
Contact: Bodil G. Pedersen, MD, PhD 40465581 ext 0045 bodilped@rm.dk
Contact: Karina D. Sørensen, Professor 78455316 ext 0045 kdso@clin.au.dk

Locations
Denmark
General Practice Recruiting
Aarhus, Central Denmark Region, Denmark, 8200
Contact: Bodil Ginnerup Pedersen    45 +45 40465581      
Sponsors and Collaborators
Aarhus University Hospital
Regional Hospital Holstebro
University of Aarhus
Central Denmark Region
Karolinska Institutet
Karolinska University Hospital
Investigators
Principal Investigator: Bodil G. Pedersen, MD, PhD Department of Radiology, Aarhus University Hospital
Principal Investigator: Karina D. Sørensen, Professor Dept. of Molecular Medicine (MOMA) at Aarhus University Hospital

Responsible Party: Aarhus University Hospital
ClinicalTrials.gov Identifier: NCT03431753     History of Changes
Other Study ID Numbers: PRIMA
First Posted: February 13, 2018    Key Record Dates
Last Update Posted: February 13, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Aarhus ( Aarhus University Hospital ):
STHLM3-test
prostate cancer
MR-imaging
MR-targeted biopsy
MRI
Novel biomarkers
Genetic screening

Additional relevant MeSH terms:
Prostatic Neoplasms
Adenocarcinoma
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type