Early and Accurate Detection of Prostate Cancer in General Practice

Prostate Cancer Clinical Trial

Official title:

Early and Accurate Detection of Prostate Cancer in General Practice Using Novel Molecular Biomarkers and Multiparametric MR Imaging.

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03431753
• Other study ID #: PRIMA
• Status: Enrolling by invitation
• Phase: N/A
• Start date: January 1, 2018
• Est. completion date: December 31, 2021

Study information

• Verified date: October 2020
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 3000
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 50 Years to 69 Years

Eligibility

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

Related Conditions & MeSH terms

• Prostate Adenocarcinoma
• Prostate Cancer
• Prostate Neoplasm
• Prostatic Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Denmark	General Practice	Aarhus	Central Denmark Region

Sponsors (6)

Lead Sponsor	Collaborator
Aarhus University Hospital	Central Denmark Region, Karolinska Institutet, Karolinska University Hospital, Regional Hospital Holstebro, University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	Compare results from clinical study with current clinical practice.	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