bpMRI and Risk Based Shared Clinical Decision Making in Prostate Cancer Diagnosis

Recruiting now · Not applicable

Conditions studied: Prostate Cancer

In brief

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.

Key facts

Study ID

NCT04287088

Run by

Turku University Hospital

People needed

600

Starts

2020-02-17

Expected to finish

2041-12-31

Last updated by the study team

2021-11-23

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• previous diagnosis of prostate cancer
• any contraindications for MRI
• any other conditions that might compromise patient's safety, based on the clinical judgment of the responsible urologist
• bilateral hip prosthesis

Where it is running

• Central Finland Central Hospital — Jyväskylä, Finland (enrolling)
• Satakunta Central Hospital — Pori, Finland (enrolling)
• Tampere University Hospital — Tampere, Finland (enrolling)
• Turku University Hospital — Turku, Finland (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.