bpMRI and Risk Based Shared Clinical Decision Making in Prostate Cancer Diagnosis
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
| Condition(s) | Prostate Cancer |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | 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 wh |
| Who can participate | Inclusion Criteria: * 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 Exclusion Criteria: * 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 |
| Ages | 18 Years |
| Sex | Male |
| Lead sponsor | Turku University Hospital |
| Locations | Jyväskylä, Finland; Pori, Finland; Tampere, Finland; Turku, Finland |
| Start date | 2020-02-17 |
| NCT ID | NCT04287088 |
| Official listing | https://clinicaltrials.gov/study/NCT04287088 |