Prostate CancerPRORANDNCT07422597
Prostate Risk Or Radiology Assessment Non-inferiority Design, Upfront MRI or Risk Calculator in Men With Suspected Prostate Cancer
A study testing European Study of screening for prostate cancer risk calculator in people with Prostate Cancer, run by Norwegian University of Science and Technology at 3 sites in Norway.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 to 75 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- European Study of screening for prostate cancer risk calculator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,016 participants
- Where
- 3 sitesNorway
- Study dates
- 1 Mar 2026to 31 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- more than 10 years remaining life expectancy
- Suspected localized prostate cancer
- Suspicious DRE (cT2)
- PSA 3-20 ng/ml
Who cannot join
- cT3 and/or cT4 (on DRE)
- PSA >20 ng/ml
- Prior diagnosis of prostate cancer
- Contraindications to MRI or to prostate biopsy
- Medications known to affect serum PSA levels
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Norway3 sites, 3 recruiting
- Not yet recruiting
Sykehuset Levanger
Levanger, 7601
Vegar Karlsen, MD, +47 74098000, Vegar.Karlsen@helse-nordtrondelag.no
- Recruiting
Orkdal sjukehus
Orkanger
Petter Davik, MD, PhD, +47 72829919, petter.davik@ntnu.no
Joakim S Lund, MD, Joakim.Schistad.Lund@stolav.no
- Recruiting
St Olavs Hospital
Trondheim, 7030
Petter Davik, MD, PhD, +47 72829919, petter.davik@ntnu.no
petter.davik@ntnu.no
About this study
Official title: PRORAND - Prostate Risk or Radiology Assessment Non-inferiority Design, a Comparison of Upfront MRI vs Risk Calculator in Men With Suspected Prostate Cancer
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.
Read the detailed description
Background Prostate cancer (PCa) is the most common non-skin cancer among men. Most PCa cases are identified after an elevated prostate-specific antigen (PSA) level has been identified on blood testing. In most men this leads to a hospital referral, magnetic resonance imaging (MRI) of the prostate, and biopsy (tissue sampling) of the prostate in men where MRI is suggestive of a prostate cancer.
Although the PSA-test is the main method for identifying men who have prostate cancer, the test has low specificity, meaning that many men with an elevated PSA-level do not harbour PCa that will cause the man harm within his lifetime. In current clinical practice, such "false" PSA elevations can be difficult to distinguish from the "true" elevations found in men with clinically significant PCa (csPCa, Gleason >3+3) and therefore still lead to an MRI, and in many cases even a biopsy procedure is necessary to exclude csPCa.
Multivariable risk stratification uses the statistical methods of machine learning to quantify a man's probability of having prostate cancer based on other information that is available about the patient, which is known to affect the likelihood of him having prostate cancer. The aim of such stratification is to improve the identification of men who are likely to have prostate cancer, beyond the capacity of the unspecific PSA test, with its many false positives. This in order to improve identification of men who actually need further diagnostic testing, and to better distinguish these men from those men where the probability of significant disease is so low that further investigations can safely be omitted, without missing cases of significant disease.
Although such risk stratification tools have previously been developed, are readily available, and in retrospective studies have been demonstrated to reduce unnecessary MRIs and biopsies considerably, clinical uptake continues to be low due to the lack of prospective trials demonstrating efficacy and safety. As a result, at present, almost all men referred with a suspicion of prostate cancer undergo MRI and subsequent clinical assessment for biopsy. In health care settings where PCa-screening is implemented, as is a stated goal in the EU Council cancer screening guidelines, the number of men requiring diagnostic work-up will likely increase dramatically in ensuing years.
Knowledge gaps The risk calculators (RCs) stemming from the European Randomised Study of Screening for Prostate Cancer (ERSPC) are the currently best known and most utilised multivariable risk stratification tools. Their use has been retrospectively validated in multiple studies. All presently available development, and almost all validating studies are, however, hampered by their retrospective design and varying size which presently hinder widespread clinical implementation of this promising new method. In the only prospective study known to us, 47% of MRI investigations could be avoided compared with today's practice of performing an MRI in all men referred with an elevated PSA (>3ng/ml). However, this study was not designed to answer the primary research question of the present proposal, namely whether this RC approach gives csPCa detection that is non-inferior to performing an MRI in all referred men. As a result, although multivariable risk stratification of men with suspected PCa holds promise, whether the method gives non-inferior cancer detection to current practice represents a key knowledge gap which presently limits its implementation.
Study aims The primary objective of the current proposal is to perform the first prospective, adequately powered investigation of whether risk stratification using the risk stratification calculators from the European Randomised Study of Screening for Prostate Cancer study gives non-inferior detection of clinically significant prostate cancer compared with performing an MRI in all men referred with a suspicion of prostate cancer.
How clinical decision-making in men suspected of harbouring PCa affects men's health-related quality of life also has not been thoroughly investigated. And similarly, whether multivariable risk stratification is in fact cost-efficient compared with an MRI-all approach has not been conclusively determined in a prospective, clinical trial. The secondary aims of the study are to examine how the decision of whether to perform biopsy affects the health-related quality of life of men who undergo such consideration, and to prospectively determine the cost-efficiency of performing multivariable risk stratification, compared with performing an MRI in all men referred with a suspicion of prostate cancer.
- Conditions
- Prostate Cancer
- Being tested
- European Study of screening for prostate cancer risk calculator
- Keywords
- Suspected prostate cancer, Elevated PSA
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
European Study of screening for prostate cancer risk calculatorDevice
Also called https://www.prostatecancer-riskcalculator.com/, Rotterdam prostate cancer risk calculator
The 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.
| Study group | Role | What they receive |
|---|---|---|
| Upfront MRI and Multivariable risk assessment in all men | Experimental | Single group Receives: Device: European Study of screening for prostate cancer risk calculator |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During the initial diagnostic work-up (up to 6 weeks)
Secondary outcomes (10)
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
Measured: During the initial diagnostic work-up (up to 6 weeks)
Numbers of prostate biopsy sessions required
Determine the number of prostata biopsy sessions required by the upfront MRI vs upfront RC strategies
Measured: 1 year after completion of inclusion
Numbers of prostate MRIs required
Determine the number of prostate MRI scans required by the upfront MRI vs upfront RC strategies
Measured: 1 year after completion of inclusion
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.
Measured: 1 year after study inclusion is completed
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: IPSS (International Prostate Symptom Score). Higher scores mean more symptoms. IPSS classifies symptoms as mild (0-7), moderate (8-19), or severe (20-35)
Measured: 1 year after study inclusion is completed
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: IIEF-5 (International Index of Erectile Function) Lower IIEF-5 scores mean higher degree of erectile dysfunction
Measured: 1 year after study inclusion is completed
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.
Participants will be asked whether they are concerned about the possibility that they may have prostate cancer (yes/no), and about how concerned about the posibility they have cancer (no concerns, mild concerns, moderate concerns, severe concerns).
Measured: 1 year after study inclusion is completed
Cost-effectiveness assessment
Determine cost-effectivenes of upfront MRI vs upfront RC. The investigators will determine the incremental cost-effectiveness ratio (ICER) and the net monetary benefit (NMB)
Measured: 1 year after completion of inclusion
Perilesional biopsy results
Targeted biopsies will be taken from PI-RADS 3-5 lesions on MRI. Additional biopsies are to be taken from the area of prostate surrounding the lesion in the prostate seen on MRI, as per current European Urological Association guidelines. The study will assess the value of perilesional biopsies by recording the detection of prostate cancer in such perilesional biopsies.
Measured: During the initial diagnostic work up (up to 6 weeks)
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: The Memorial Anxiety Scale for Prostate Cancer (MAX-PC). An 18-item, validated questionnaire designed to measure cancer-specific anxiety in men, specifically covering prostate cancer anxiety, prostate-specific antigen sampling anxiety, and fear of cancer recurrence. Higher scores mean higher degree of anxiety relating to prostate cancer and to prostate-specific antigen testing.
Measured: 1 year after study inclusion is completed.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2026
- Study start1 Mar 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, within patient non-inferiority study comparing upfront risk assessments by MRI and risk calculator
- Masking
- None (open label)
- Enrolment
- 1,016 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian Cancer Society
- Responsible party
- Sponsor
- Investigators
- Petter Davik, MD, PhD, Principal investigator, Norwegian University of Science and Technology (NTNU)Magnus Steigedal, PhD, Study chair, Norwegian University of Science and Technology, Head of Department (IKOM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07422597
- Sponsor's protocol ID
- REK KULMU 927238
- Acronym
- PRORAND
- Status last verified
- Oct 2026
- First submitted
- 30 Dec 2025
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Sharing of anonmous data for scientific purposeswill be considered upon reasonable request
Publications
Straat KRV, Hagens MJ, Cools Paulino Pereira LJ, van den Bergh RCN, Mazel JW, Noordzij MA, Rynja SP. Risk Calculator Strategy Before Magnetic Resonance Imaging Stratification for Biopsy-naive Men with Suspicion for Prostate Cancer: A Cost-effectiveness Analysis. Eur Urol Open Sci. 2024 Oct 14;70:52-57. doi: 10.1016/j.euros.2024.08.017. eCollection 2024 Dec.
PubMed 39483520Sharp L, Morgan E, Drummond FJ, Gavin A. The psychological impact of prostate biopsy: Prevalence and predictors of procedure-related distress. Psychooncology. 2018 Feb;27(2):500-507. doi: 10.1002/pon.4521. Epub 2017 Oct 11.
PubMed 28766309Coyle C, Morgan E, Drummond FJ, Sharp L, Gavin A. Do men regret prostate biopsy: Results from the PiCTure study. BMC Urol. 2017 Jan 26;17(1):11. doi: 10.1186/s12894-016-0194-y.
PubMed 28125998Reesink DJ, Schilham MGM, van der Hoeven EJRJ, Schoots IG, van Melick HHE, van den Bergh RCN. Comparison of risk-calculator and MRI and consecutive pathways as upfront stratification for prostate biopsy. World J Urol. 2021 Jul;39(7):2453-2461. doi: 10.1007/s00345-020-03488-2. Epub 2020 Oct 22.
PubMed 33090259Davik P, Remmers S, Elschot M, Roobol MJ, Bathen TF, Bertilsson H. Reducing prostate biopsies and magnetic resonance imaging with prostate cancer risk stratification. BJUI Compass. 2022 Apr 22;3(5):344-353. doi: 10.1002/bco2.146. eCollection 2022 Sep.
PubMed 35950035Davik P, Elschot M, Frost Bathen T, Bertilsson H. Repeat Prostate-specific Antigen Testing Improves Risk-based Selection of Men for Prostate Biopsy After Magnetic Resonance Imaging. Eur Urol Open Sci. 2024 Jun 13;65:21-28. doi: 10.1016/j.euros.2024.05.011. eCollection 2024 Jul.
PubMed 38974460Patel HD, Remmers S, Ellis JL, Li EV, Roobol MJ, Fang AM, Davik P, Rais-Bahrami S, Murphy AB, Ross AE, Gupta GN. Comparison of Magnetic Resonance Imaging-Based Risk Calculators to Predict Prostate Cancer Risk. JAMA Netw Open. 2024 Mar 4;7(3):e241516. doi: 10.1001/jamanetworkopen.2024.1516.
PubMed 38451522Davik P, Remmers S, Elschot M, Roobol MJ, Bathen TF, Bertilsson H. Performance of magnetic resonance imaging-based prostate cancer risk calculators and decision strategies in two large European medical centres. BJU Int. 2024 Mar;133(3):278-288. doi: 10.1111/bju.16163. Epub 2023 Sep 12.
PubMed 37607322Hofmann B, Haug ES, Andersen ER, Kjelle E. Increased magnetic resonance imaging in prostate cancer management-What are the outcomes? J Eval Clin Pract. 2023 Sep;29(6):893-902. doi: 10.1111/jep.13791. Epub 2022 Nov 14.
PubMed 36374190Thompson IM, Ankerst DP, Chi C, Goodman PJ, Tangen CM, Lucia MS, Feng Z, Parnes HL, Coltman CA Jr. Assessing prostate cancer risk: results from the Prostate Cancer Prevention Trial. J Natl Cancer Inst. 2006 Apr 19;98(8):529-34. doi: 10.1093/jnci/djj131.
PubMed 16622122
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PRORAND - Prostate Risk or Radiology Assessment Non-inferiority Design, a Comparison of Upfront MRI vs Risk Calculator in Men With Suspected Prostate Cancer
- ClinicalTrials.gov ID
- NCT07422597
- Acronym / sponsor ID
- PRORAND / REK KULMU 927238
- Conditions
- Prostate Cancer
- Keywords
- Suspected prostate cancer, Elevated PSA
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,016 participants (estimated)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- Norwegian Cancer Society
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 20 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background Prostate cancer (PCa) is the most common non-skin cancer among men. Most PCa cases are identified after an elevated prostate-specific antigen (PSA) level has been identified on blood testing. In most men this leads to a hospital referral, magnetic resonance imaging (MRI) of the prostate, and biopsy (tissue sampling) of the prostate in men where MRI is suggestive of a prostate cancer.
Although the PSA-test is the main method for identifying men who have prostate cancer, the test has low specificity, meaning that many men with an elevated PSA-level do not harbour PCa that will cause the man harm within his lifetime. In current clinical practice, such "false" PSA elevations can be difficult to distinguish from the "true" elevations found in men with clinically significant PCa (csPCa, Gleason >3+3) and therefore still lead to an MRI, and in many cases even a biopsy procedure is necessary to exclude csPCa.
Multivariable risk stratification uses the statistical methods of machine learning to quantify a man's probability of having prostate cancer based on other information that is available about the patient, which is known to affect the likelihood of him having prostate cancer. The aim of such stratification is to improve the identification of men who are likely to have prostate cancer, beyond the capacity of the unspecific PSA test, with its many false positives. This in order to improve identification of men who actually need further diagnostic testing, and to better distinguish these men from those men where the probability of significant disease is so low that further investigations can safely be omitted, without missing cases of significant disease.
Although such risk stratification tools have previously been developed, are readily available, and in retrospective studies have been demonstrated to reduce unnecessary MRIs and biopsies considerably, clinical uptake continues to be low due to the lack of prospective trials demonstrating efficacy and safety. As a result, at present, almost all men referred with a suspicion of prostate cancer undergo MRI and subsequent clinical assessment for biopsy. In health care settings where PCa-screening is implemented, as is a stated goal in the EU Council cancer screening guidelines, the number of men requiring diagnostic work-up will likely increase dramatically in ensuing years.
Knowledge gaps The risk calculators (RCs) stemming from the European Randomised Study of Screening for Prostate Cancer (ERSPC) are the currently best known and most utilised multivariable risk stratification tools. Their use has been retrospectively validated in multiple studies. All presently available development, and almost all validating studies are, however, hampered by their retrospective design and varying size which presently hinder widespread clinical implementation of this promising new method. In the only prospective study known to us, 47% of MRI investigations could be avoided compared with today's practice of performing an MRI in all men referred with an elevated PSA (>3ng/ml). However, this study was not designed to answer the primary research question of the present proposal, namely whether this RC approach gives csPCa detection that is non-inferior to performing an MRI in all referred men. As a result, although multivariable risk stratification of men with suspected PCa holds promise, whether the method gives non-inferior cancer detection to current practice represents a key knowledge gap which presently limits its implementation.
Study aims The primary objective of the current proposal is to perform the first prospective, adequately powered investigation of whether risk stratification using the risk stratification calculators from the European Randomised Study of Screening for Prostate Cancer study gives non-inferior detection of clinically significant prostate cancer compared with performing an MRI in all men referred with a suspicion of prostate cancer.
How clinical decision-making in men suspected of harbouring PCa affects men's health-related quality of life also has not been thoroughly investigated. And similarly, whether multivariable risk stratification is in fact cost-efficient compared with an MRI-all approach has not been conclusively determined in a prospective, clinical trial. The secondary aims of the study are to examine how the decision of whether to perform biopsy affects the health-related quality of life of men who undergo such consideration, and to prospectively determine the cost-efficiency of performing multivariable risk stratification, compared with performing an MRI in all men referred with a suspicion of prostate cancer.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, within patient non-inferiority study comparing upfront risk assessments by MRI and risk calculator
| Arm | Type | Receives |
|---|---|---|
| Upfront MRI and Multivariable risk assessment in all men | Experimental | Device: European Study of screening for prostate cancer risk calculatorSingle group |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- more than 10 years remaining life expectancy
- Suspected localized prostate cancer
- Suspicious DRE (cT2)
- PSA 3-20 ng/ml
Key exclusion criteria (5 listed)
- cT3 and/or cT4 (on DRE)
- PSA >20 ng/ml
- Prior diagnosis of prostate cancer
- Contraindications to MRI or to prostate biopsy
- Medications known to affect serum PSA levels
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| European Study of screening for prostate cancer risk calculatorAlso: https://www.prostatecancer-riskcalculator.com/, Rotterdam prostate cancer risk calculatorThe 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. | Device | Upfront MRI and Multivariable risk assessment in all men |
Primary outcome
Detection of clinically significant prostate cancer
Time frame: During the initial diagnostic work-up (up to 6 weeks)
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.
10 secondary outcomes
Detection of clinically insignificant prostate cancer
Time frame: During the initial diagnostic work-up (up to 6 weeks)
Numbers of prostate biopsy sessions required
Time frame: 1 year after completion of inclusion
Numbers of prostate MRIs required
Time frame: 1 year after completion of inclusion
Quality of life effect of decision to perfrom prostate biopsy
Time frame: 1 year after study inclusion is completed
Quality of life effect of decision to perfrom prostate biopsy
Time frame: 1 year after study inclusion is completed
Quality of life effect of decision to perfrom prostate biopsy
Time frame: 1 year after study inclusion is completed
Quality of life effect of decision to perfrom prostate biopsy
Time frame: 1 year after study inclusion is completed
Cost-effectiveness assessment
Time frame: 1 year after completion of inclusion
Perilesional biopsy results
Time frame: During the initial diagnostic work up (up to 6 weeks)
Quality of life effect of decision to perfrom prostate biopsy
Time frame: 1 year after study inclusion is completed.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Background: PubMed 39483520Straat KRV, Hagens MJ, Cools Paulino Pereira LJ, van den Bergh RCN, Mazel JW, Noordzij MA, Rynja SP. Risk Calculator Strategy Before Magnetic Resonance Imaging Stratification for Biopsy-naive Men with Suspicion for Prostate Cancer: A Cost-effectiveness Analysis. Eur Urol Open Sci. 2024 Oct 14;70:52-57. doi: 10.1016/j.euros.2024.08.017. eCollection 2024 Dec.
- Background: PubMed 28766309Sharp L, Morgan E, Drummond FJ, Gavin A. The psychological impact of prostate biopsy: Prevalence and predictors of procedure-related distress. Psychooncology. 2018 Feb;27(2):500-507. doi: 10.1002/pon.4521. Epub 2017 Oct 11.
- Background: PubMed 28125998Coyle C, Morgan E, Drummond FJ, Sharp L, Gavin A. Do men regret prostate biopsy: Results from the PiCTure study. BMC Urol. 2017 Jan 26;17(1):11. doi: 10.1186/s12894-016-0194-y.
- Background: PubMed 33090259Reesink DJ, Schilham MGM, van der Hoeven EJRJ, Schoots IG, van Melick HHE, van den Bergh RCN. Comparison of risk-calculator and MRI and consecutive pathways as upfront stratification for prostate biopsy. World J Urol. 2021 Jul;39(7):2453-2461. doi: 10.1007/s00345-020-03488-2. Epub 2020 Oct 22.
- Background: PubMed 35950035Davik P, Remmers S, Elschot M, Roobol MJ, Bathen TF, Bertilsson H. Reducing prostate biopsies and magnetic resonance imaging with prostate cancer risk stratification. BJUI Compass. 2022 Apr 22;3(5):344-353. doi: 10.1002/bco2.146. eCollection 2022 Sep.
- Background: PubMed 38974460Davik P, Elschot M, Frost Bathen T, Bertilsson H. Repeat Prostate-specific Antigen Testing Improves Risk-based Selection of Men for Prostate Biopsy After Magnetic Resonance Imaging. Eur Urol Open Sci. 2024 Jun 13;65:21-28. doi: 10.1016/j.euros.2024.05.011. eCollection 2024 Jul.
- Background: PubMed 38451522Patel HD, Remmers S, Ellis JL, Li EV, Roobol MJ, Fang AM, Davik P, Rais-Bahrami S, Murphy AB, Ross AE, Gupta GN. Comparison of Magnetic Resonance Imaging-Based Risk Calculators to Predict Prostate Cancer Risk. JAMA Netw Open. 2024 Mar 4;7(3):e241516. doi: 10.1001/jamanetworkopen.2024.1516.
- Background: PubMed 37607322Davik P, Remmers S, Elschot M, Roobol MJ, Bathen TF, Bertilsson H. Performance of magnetic resonance imaging-based prostate cancer risk calculators and decision strategies in two large European medical centres. BJU Int. 2024 Mar;133(3):278-288. doi: 10.1111/bju.16163. Epub 2023 Sep 12.
- Background: PubMed 36374190Hofmann B, Haug ES, Andersen ER, Kjelle E. Increased magnetic resonance imaging in prostate cancer management-What are the outcomes? J Eval Clin Pract. 2023 Sep;29(6):893-902. doi: 10.1111/jep.13791. Epub 2022 Nov 14.
- Background: PubMed 16622122Thompson IM, Ankerst DP, Chi C, Goodman PJ, Tangen CM, Lucia MS, Feng Z, Parnes HL, Coltman CA Jr. Assessing prostate cancer risk: results from the Prostate Cancer Prevention Trial. J Natl Cancer Inst. 2006 Apr 19;98(8):529-34. doi: 10.1093/jnci/djj131.
- Individual participant dataSharing planned: Yes. Sharing of anonmous data for scientific purposeswill be considered upon reasonable request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Petter Davik, MD, PhD principal investigator
Norwegian University of Science and Technology (NTNU)
Magnus Steigedal, PhD study chair
Norwegian University of Science and Technology, Head of Department (IKOM)
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing European Study of screening for prostate cancer risk calculator in people with Prostate Cancer, run by Norwegian University of Science and Technology at 3 sites in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Petter Davik, MD, PhD (+47 72829919, petter.davik@ntnu.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of clinically significant prostate cancer (time frame: During the initial diagnostic work-up (up to 6 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07422597, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.