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| Name | Class |
|---|---|
| Regional Hospital Holstebro | OTHER |
| University of Aarhus | OTHER |
| Central Denmark Region | OTHER |
| Karolinska Institutet |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PSA, STHLM3 and mpMRI for PC detection | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PSA, STHLM3 and mpMRI for PC detection | Diagnostic Test | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of PC suspicious lesions detected by mpMRI based on the STHLM3 test vs. the prostate specific antigen test. | Evaluation of the proportion of patients identified with PC suspicious lesions at mpMRI based on the STHLM3 vs. the prostate specific antigen test. | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of PC diagnoses detected in the study population based on the STHLM3 test vs. the prostate specific antigen test. | Evaluation of the proportion of total PCs and clinically significant PCs diagnosed with MR guided biopsy as a function of the primary tests. | 24 months |
| Compare results from clinical study with current clinical practice. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| General Practice | Aarhus | Central Jutland | 8200 | Denmark |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Dec 11, 2023 | |
| Reset | Jun 7, 2024 | |
| Release | Jun 18, 2024 | |
| Reset | Oct 1, 2024 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Dec 11, 2023 | Jun 7, 2024 | |||
| Jun 18, 2024 |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000081364 | Multiparametric Magnetic Resonance Imaging |
| ID | Term |
|---|---|
| D008279 | Magnetic Resonance Imaging |
| D014054 | Tomography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
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| OTHER |
| Karolinska University Hospital | OTHER |
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|
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. |
| 24 months |
| Oct 1, 2024 |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D003933 | Diagnosis |