Thousands of men take a PSA test to investigate whether they have prostate cancer every year. For the vast majority, the test is normal and further investigations are not necessary. In others, the test is sufficiently elevated that men are referred for further investigations. Most men with an elevated PSA are offered an MRI examination of the prostate gland, and for some, a tissue sample of the prostate is also recommended if the suspicion of cancer is high enough. Although this comprehensive investigation reveals most clinically significant , or dangerous cases of cancer, many indolent, or "harmless" cancer cases are also detected, which would not have caused the man any harm during his lifetime (approximately 20% of all prostate cancer diagnoses diagnosed in current clinical practive). Cancer treatment is not recommended for such cases, but for many men, the diagnosis and subsequent follow-up can cause him and his family anxity and concern. In addition, prostate biopsies are unpleasant for the patient and the investigation process is resource-intensive for both the man and the health care service.
Risk stratification uses machine learning methods to better identify the men who require further investigations with MRI and tissue samples. In this project, the investigators investigate whether the best risk stratification tools are non-inferior in detecting clinically significant prostate cancer compared to current practice, and whether they lead to fewer tissue samples, MRI scans, less health anxiety, and better cost-effectiveness.
more than 10 years remaining life expectancy
Suspected localized prostate cancer
Suspicious DRE (cT2)
PSA 3-20 ng/ml
cT3 and/or cT4 (on DRE)
PSA >20 ng/ml
Prior diagnosis of prostate cancer
Contraindications to MRI or to prostate biopsy
Single group
European Study of screening for prostate cancer risk calculator
DeviceThe ERSPC RCs are the currently best known and most utilised multivariable PCa risk stratification tools. All participating men undergo risk stratification by ERSPC RCs to determine need for MRI and for biopsy.
Detection of clinically significant prostate cancer
The study examines whether the risk calculator strategy gives non-inferior detection of csPCa compared with performing an MRI upfront in all men. csPCa defined as International society of Urological pathology grade group (ISUP GG) \>1.
Detection of clinically insignificant prostate cancer
The investigators will compare the number of patients with low grade (ISUP GG 1) prostate cancer detected by the upfront MRI vs upfront RC strategies
Numbers of prostate biopsy sessions required
Determine the number of prostata biopsy sessions required by the upfront MRI vs upfront RC strategies
Numbers of prostate MRIs required
Determine the number of prostate MRI scans required by the upfront MRI vs upfront RC strategies
Quality of life effect of decision to perfrom prostate biopsy
The investigators assess the health-related quality of life effect of the decision to perform biopsy in men referred with suspected prostate cancer. Questionnaire that will be used to assess participants' quality of life: EORTC (European Organisation for Research and Treatment of Cancer) QLQ-C30 form. The EORTC QLQ-C30 (v3.0) scores 30 items into 5 functional scales, 9 symptom scales/items, and global health status (0-100 range). Higher scores indicate better functioning/QoL but worse symptoms.
Click on the lead sponsor to view all of their trials.
Norwegian University of Science and Technology
Lead sponsor
Norwegian Cancer Society
Collaborator
