NCT04287088Recruiting
bpMRI and Risk Based Shared Clinical Decision Making in Prostate Cancer Diagnosis
Prebiopsy Magnetic Resonance Imaging in Men With Suspicion of Prostate Cancer - A Multi-centre Trial on Clinical Utility of IMPROD bpMRI in a Shared Decision Making Setting
Source: ClinicalTrials.gov · Last updated 23 Nov 2021 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The shortcoming of the pre-biopsy prostate MRI approach is the recommendation to biopsy all men post-MRI even if there is no lesion seen in MRI, ie. risk of PCa is very low. Therefore, the primary objective of this trial is to compare if there is a difference between significant cancer detection rate in men undergoing prostate biopsies after MRI scan compared to men undergoing post-MRI prostate biopsies only after a shared decision-making based on prostate cancer risk estimation. The trial will enrol 600 patients. The primary outcome measure is the the proportion of men with CSPCa (Gleason 4+3 prostate cancer or higher) between the control and intervention arms at baseline. Eligible men are randomised 1:1 in two groups. In control arm in all men prostate biopsies are performed after MRI whereas in intervention arm prostate biopsies are performed only after a shared decision-making between urologist and the patient and the discussion is based on risk estimation.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 600 (estimated)
- First submitted
- 25 Feb 2020
- Start date
- 17 Feb 2020
- Primary completion date
- 31 Dec 2021
- Lead sponsor
- Turku University Hospital
- Diseases
- Prostate cancer
- NCT number
- NCT04287088
What you commit to
- Study type: Interventional
- Planned participants: 600
- From 17 Feb 2020 to the primary completion date, 31 Dec 2021
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- previous diagnosis of prostate cancer
Other illness
- any other conditions that might compromise patient's safety, based on the clinical judgment of the responsible urologist
Other
- any contraindications for MRI
- bilateral hip prosthesis
Who the study is looking for
- Age: 18 years or older
- Language spoken: Finnish
- Clinical suspicion of prostate cancer, based on: serum level of PSA from 2,5 ng/ml to 20 ng/ml and/or abnormal digital rectal examination according to the referral physician
- Mental status: Patients must be able to understand the meaning of the study
- Informed consent: The patient must sign the appropriate Ethics Committee (EC) approved informed consent documents in the presence of the designated staff
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Central Finland Central Hospital Coordinator of this site? Confirm its status | Jyväskylä | Finland | Recruiting |
| Satakunta Central Hospital Coordinator of this site? Confirm its status | Pori | Finland | Recruiting |
| Tampere University Hospital Coordinator of this site? Confirm its status | Tampere | Finland | Recruiting |
| Turku University Hospital Coordinator of this site? Confirm its status | Turku | Finland | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.