Prostate CancerPROSOVINCT03819751
MRI-targeted Biopsy of the Prostate: Software Versus Visual Registration in the Accuracy of Prostate Cancer Detection
A study testing MRI-targeted prostate biopsy in people with Prostate Cancer and Prostate Neoplasm, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
With the general acceptance of MRI and technical advances in biopsy technique of the prostate, new questions arise concerning the selection of patients, the approach, the appropriate technique, the lesions to target and the number of biopsies. Read more about this study
- Who is it for?
- Ages 50 to 75 years, men only
- Conditions the study is for
- Prostate Cancer, Prostate Neoplasm
- What is being tested?
- MRI-targeted prostate biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteBelgium
- Study dates
- 18 Mar 2019to Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- willing to participate in the study by giving written informed consent.
- male subjects aged between 50 to 75 years.
- with a clinical suspicion of PCa: elevated prostate specific antigen (PSA) levels in blood and/or abnormal digital rectal examination (DRE).
- good health condition based on medical history, physical examination and vital sign measurements.
- with target lesion on dedicated MRI of the prostate (PI-RADS 3 to 5).
Who cannot join
- has a prior history of prostate cancer.
- had prior prostate biopsy.
- has a contra-indication for MRI (claustrophobia, non-compatible metallic implants).
- has evidence of lymph nodes involvement on prostate MRI or abdominal CT
- has evidence of bone metastasis on bone scan.
- has a prior history of hip prosthesis, pelvic radiation therapy or androgen deprivation therapy
- unable to perform transrectal ultrasound due to prior rectal surgery or active rectal diseases (rectitis, …)
- has any condition, physical, mental, familial or sociological, that could impede compliance with the study protocol and further follow-up. This is not an absolute contra-indication, but should be discussed with patient prior to registration in the trial.
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
UZ Leuven
Leuven, Vlaams-brabant, 3000
Cindy Mai, MD, 003216345032, cindy.mai@uzleuven.be
Hilde Vandenhout, 003216343636, hilde.vandenhout@uzleuven.be
About this study
Official title: MRI-targeted Biopsy of the Prostate: a Prospective Comparison of Software-based Fusion Versus Visual (Cognitive) Registration in the Accuracy of Clinically Significant Prostate Cancer Detection
With the general acceptance of MRI and technical advances in biopsy technique of the prostate, new questions arise concerning the selection of patients, the approach, the appropriate technique, the lesions to target and the number of biopsies. The purpose of this study is to address these issues in men suspicious of having prostate cancer and without prior biopsies.
Read the detailed description
Trial Design: This is a prospective, single center, comparative, diagnostic study of two biopsy techniques. All men aged 50 to 75 years with clinical suspicion of PCa (elevated prostate specific antigen (PSA) levels in blood and/or abnormal digital rectal examination) and an MRI with suspicious lesion(s) (presence of PI-RADS 3-5 lesion) will be included. Participants receive both types of biopsy, but will be randomized concerning the order of the biopsy. All men will also receive traditional systematic biopsies. Treatment and further follow-up is according to EAU guidelines. Data of treatment and follow-up will be retrieved till 2 years after initial MRI-visit.
Sample Size: Based on McNemar test for the comparison between the accuracy of the two biopsy techniques, the required sample size is estimated on 96 patients.
Assessment of efficacy: Efficacy of software and visual registration biopsy will be determined by histopathology: cancer core length (actual length and percentage) and comparison with systematic biopsy as reference standard.
Direct access to source data and documents: The investigator(s) and the institution(s) will permit trial-related monitoring, audits, EC review, and regulatory inspections (where appropriate) by providing direct access to source data and other documents (i.e. patients' case sheets, blood test reports, X-ray reports, histology reports, etc.).
Data handling and management: All data collected during the study remain confidential and according to the GDPR regulation. Data of the participants will be retrieved from their electronic patient files. Each participant will be given a unique identification number. When data are coded, there continues to be a link between the data and the individual who provided it. The research team is obligated to protect the data from disclosure outside the research according to the terms of the research protocol and the informed consent document. The subject's name or other identifiers should be stored separately (site file) from their research data and replaced with a unique code to create a new identity for the subject. Note that coded data are not anonymous. All data is collected and stored electronically by the principal investigator and co-investigators.
- Conditions
- Prostate Cancer, Prostate Neoplasm
- Being tested
- MRI-targeted prostate biopsy
- Keywords
- prostatic neoplasms, biopsy, Multimodal Imaging, prostate
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI-targeted prostate biopsyProcedure or surgery
Also called MRI/TRUS fusion biopsy with Philips Percunav
All participants receive traditional cognitive/visual registration biopsy and the above mentioned MRI/TRUS fusion biopsy (also known as software registration biopsy)
| Study group | Role | What they receive |
|---|---|---|
| MRI-targeted prostate biopsy | Other | Participants receive both type of MRI-targeted biopsy. Patients are randomized with one half having visual registration first and the other half having software registration first. Receives: Procedure: MRI-targeted prostate biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of the two MR-guided registration techniques (visual and software-based) in the detection of clinically significant prostate cancer
Assessment of the detection rate of clinically significant prostate cancer of software registration biopsy and visual registration biopsy, using traditional TRUS-guided systematic biopsy, whole mount radical prostatectomy specimen and follow-up as reference.
Measured: From MRI-visit till results of radical prostatectomy is known or till up to 2 years after MRI-visit
Secondary outcomes (4)
Analysis of the performance of software versus visual registration biopsy in subgroups
Assessment of the performance of software registration biopsy and visual registration biopsy in the detection of clinically significant cancer in :
- lesions in small volume prostates (<50 gram) versus large volume prostates (>50 gram).
- transitional zone versus peripheral zone lesions
- basal versus apical lesions
- small (max. diameter < or = 10 mm) versus large lesions (max. diameter > 10 mm)
- intermediate suspicious lesions (PI-RADS 3) versus highly suspicious lesions (PI-RADS 4-5).
Measured: From MRI-visit till results of radical prostatectomy is known or till up to 2 years after MRI-visit
Added value of systematic biopsies
Assessment of the added value of systematic biopsies on top of MRI-targeted biopsy of PI-RADS 3, 4 and 5 lesions. Compare MRI-targeted + systematic biopsies versus MRI-targeted biopsies alone in T-staging and therapy options.
Measured: From MRI-visit till results of radical prostatectomy is known or till up to 2 years after MRI-visit
Discriminative features of PI-RADS 3 lesions on MRI
Lesion diameters, shape, intensity on T2 and aspect, ADC-values on ADC-map will be measured to identify possible discriminative features of 'malignant' s "benigne" PI-RADS 3 lesions.
Measured: From MRI-visit till results of radical prostatectomy is known or till up to 2 years after MRI-visit
Features of prostate cancer differentiation grade on MRI
Measure ADC-value to differentiate prostate cancer differentiation grade.
Measured: From MRI-visit till results of radical prostatectomy is known or till up to 2 years after MRI-visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2019
- Study start18 Mar 2019
- Primary completionFeb 2025 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)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 Universitaire Ziekenhuizen KU LeuvenThe 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
- All patients receive both types of biopsy. Patients are randomized with one half having visual registration first and the other half having software registration first.
- Masking
- None (open label)
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cindy Mai, MD, Principal investigator, University Hospital Leuven, Department of Radiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03819751
- Sponsor's protocol ID
- s.nr
- Acronym
- PROSOVI
- Status last verified
- Jul 2024
- First submitted
- 22 Jan 2019
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mottet N, Bellmunt J, Bolla M, Briers E, Cumberbatch MG, De Santis M, Fossati N, Gross T, Henry AM, Joniau S, Lam TB, Mason MD, Matveev VB, Moldovan PC, van den Bergh RCN, Van den Broeck T, van der Poel HG, van der Kwast TH, Rouviere O, Schoots IG, Wiegel T, Cornford P. EAU-ESTRO-SIOG Guidelines on Prostate Cancer. Part 1: Screening, Diagnosis, and Local Treatment with Curative Intent. Eur Urol. 2017 Apr;71(4):618-629. doi: 10.1016/j.eururo.2016.08.003. Epub 2016 Aug 25.
PubMed 27568654Futterer JJ, Briganti A, De Visschere P, Emberton M, Giannarini G, Kirkham A, Taneja SS, Thoeny H, Villeirs G, Villers A. Can Clinically Significant Prostate Cancer Be Detected with Multiparametric Magnetic Resonance Imaging? A Systematic Review of the Literature. Eur Urol. 2015 Dec;68(6):1045-53. doi: 10.1016/j.eururo.2015.01.013. Epub 2015 Feb 2.
PubMed 25656808Ahmed HU, El-Shater Bosaily A, Brown LC, Gabe R, Kaplan R, Parmar MK, Collaco-Moraes Y, Ward K, Hindley RG, Freeman A, Kirkham AP, Oldroyd R, Parker C, Emberton M; PROMIS study group. Diagnostic accuracy of multi-parametric MRI and TRUS biopsy in prostate cancer (PROMIS): a paired validating confirmatory study. Lancet. 2017 Feb 25;389(10071):815-822. doi: 10.1016/S0140-6736(16)32401-1. Epub 2017 Jan 20.
PubMed 28110982Kasivisvanathan V, Emberton M, Moore CM. MRI-Targeted Biopsy for Prostate-Cancer Diagnosis. N Engl J Med. 2018 Aug 9;379(6):589-590. doi: 10.1056/NEJMc1807507. No abstract available.
PubMed 30089067Moore CM, Robertson NL, Arsanious N, Middleton T, Villers A, Klotz L, Taneja SS, Emberton M. Image-guided prostate biopsy using magnetic resonance imaging-derived targets: a systematic review. Eur Urol. 2013 Jan;63(1):125-40. doi: 10.1016/j.eururo.2012.06.004. Epub 2012 Jun 13.
PubMed 22743165Logan JK, Rais-Bahrami S, Turkbey B, Gomella A, Amalou H, Choyke PL, Wood BJ, Pinto PA. Current status of magnetic resonance imaging (MRI) and ultrasonography fusion software platforms for guidance of prostate biopsies. BJU Int. 2014 Nov;114(5):641-52. doi: 10.1111/bju.12593. Epub 2014 May 22.
PubMed 24298917Wysock JS, Rosenkrantz AB, Huang WC, Stifelman MD, Lepor H, Deng FM, Melamed J, Taneja SS. A prospective, blinded comparison of magnetic resonance (MR) imaging-ultrasound fusion and visual estimation in the performance of MR-targeted prostate biopsy: the PROFUS trial. Eur Urol. 2014 Aug;66(2):343-51. doi: 10.1016/j.eururo.2013.10.048. Epub 2013 Nov 8.
PubMed 24262102Puech P, Rouviere O, Renard-Penna R, Villers A, Devos P, Colombel M, Bitker MO, Leroy X, Mege-Lechevallier F, Comperat E, Ouzzane A, Lemaitre L. Prostate cancer diagnosis: multiparametric MR-targeted biopsy with cognitive and transrectal US-MR fusion guidance versus systematic biopsy--prospective multicenter study. Radiology. 2013 Aug;268(2):461-9. doi: 10.1148/radiol.13121501. Epub 2013 Apr 11.
PubMed 23579051Moore CM, Kasivisvanathan V, Eggener S, Emberton M, Futterer JJ, Gill IS, Grubb Iii RL, Hadaschik B, Klotz L, Margolis DJ, Marks LS, Melamed J, Oto A, Palmer SL, Pinto P, Puech P, Punwani S, Rosenkrantz AB, Schoots IG, Simon R, Taneja SS, Turkbey B, Ukimura O, van der Meulen J, Villers A, Watanabe Y; START Consortium. Standards of reporting for MRI-targeted biopsy studies (START) of the prostate: recommendations from an International Working Group. Eur Urol. 2013 Oct;64(4):544-52. doi: 10.1016/j.eururo.2013.03.030. Epub 2013 Mar 20.
PubMed 23537686
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MRI-targeted Biopsy of the Prostate: a Prospective Comparison of Software-based Fusion Versus Visual (Cognitive) Registration in the Accuracy of Clinically Significant Prostate Cancer Detection
- ClinicalTrials.gov ID
- NCT03819751
- Acronym / sponsor ID
- PROSOVI / s.nr
- Conditions
- Prostate Cancer, Prostate Neoplasm
- Keywords
- prostatic neoplasms, biopsy, Multimodal Imaging, prostate
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 18 Mar 2019 (actual)
- Primary completion
- Feb 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 28 Jan 2019 (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.
With the general acceptance of MRI and technical advances in biopsy technique of the prostate, new questions arise concerning the selection of patients, the approach, the appropriate technique, the lesions to target and the number of biopsies. The purpose of this study is to address these issues in men suspicious of having prostate cancer and without prior biopsies.
Detailed description
Trial Design: This is a prospective, single center, comparative, diagnostic study of two biopsy techniques. All men aged 50 to 75 years with clinical suspicion of PCa (elevated prostate specific antigen (PSA) levels in blood and/or abnormal digital rectal examination) and an MRI with suspicious lesion(s) (presence of PI-RADS 3-5 lesion) will be included. Participants receive both types of biopsy, but will be randomized concerning the order of the biopsy. All men will also receive traditional systematic biopsies. Treatment and further follow-up is according to EAU guidelines. Data of treatment and follow-up will be retrieved till 2 years after initial MRI-visit.
Sample Size: Based on McNemar test for the comparison between the accuracy of the two biopsy techniques, the required sample size is estimated on 96 patients.
Assessment of efficacy: Efficacy of software and visual registration biopsy will be determined by histopathology: cancer core length (actual length and percentage) and comparison with systematic biopsy as reference standard.
Direct access to source data and documents: The investigator(s) and the institution(s) will permit trial-related monitoring, audits, EC review, and regulatory inspections (where appropriate) by providing direct access to source data and other documents (i.e. patients' case sheets, blood test reports, X-ray reports, histology reports, etc.).
Data handling and management: All data collected during the study remain confidential and according to the GDPR regulation. Data of the participants will be retrieved from their electronic patient files. Each participant will be given a unique identification number. When data are coded, there continues to be a link between the data and the individual who provided it. The research team is obligated to protect the data from disclosure outside the research according to the terms of the research protocol and the informed consent document. The subject's name or other identifiers should be stored separately (site file) from their research data and replaced with a unique code to create a new identity for the subject. Note that coded data are not anonymous. All data is collected and stored electronically by the principal investigator and co-investigators.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All patients receive both types of biopsy. Patients are randomized with one half having visual registration first and the other half having software registration first.
| Arm | Type | Receives |
|---|---|---|
| MRI-targeted prostate biopsy | Other | Procedure: MRI-targeted prostate biopsyParticipants receive both type of MRI-targeted biopsy. Patients are randomized with one half having visual registration first and the other half having software registration first. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- willing to participate in the study by giving written informed consent.
- male subjects aged between 50 to 75 years.
- with a clinical suspicion of PCa: elevated prostate specific antigen (PSA) levels in blood and/or abnormal digital rectal examination (DRE).
- good health condition based on medical history, physical examination and vital sign measurements.
- with target lesion on dedicated MRI of the prostate (PI-RADS 3 to 5).
Key exclusion criteria (8 listed)
- has a prior history of prostate cancer.
- had prior prostate biopsy.
- has a contra-indication for MRI (claustrophobia, non-compatible metallic implants).
- has evidence of lymph nodes involvement on prostate MRI or abdominal CT
- has evidence of bone metastasis on bone scan.
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 |
|---|---|---|
| MRI-targeted prostate biopsyAlso: MRI/TRUS fusion biopsy with Philips PercunavAll participants receive traditional cognitive/visual registration biopsy and the above mentioned MRI/TRUS fusion biopsy (also known as software registration biopsy) | Procedure or surgery | MRI-targeted prostate biopsy |
Primary outcome
Accuracy of the two MR-guided registration techniques (visual and software-based) in the detection of clinically significant prostate cancer
Time frame: From MRI-visit till results of radical prostatectomy is known or till up to 2 years after MRI-visit
Assessment of the detection rate of clinically significant prostate cancer of software registration biopsy and visual registration biopsy, using traditional TRUS-guided systematic biopsy, whole mount radical prostatectomy specimen and follow-up as reference.
4 secondary outcomes
Analysis of the performance of software versus visual registration biopsy in subgroups
Time frame: From MRI-visit till results of radical prostatectomy is known or till up to 2 years after MRI-visit
Added value of systematic biopsies
Time frame: From MRI-visit till results of radical prostatectomy is known or till up to 2 years after MRI-visit
Discriminative features of PI-RADS 3 lesions on MRI
Time frame: From MRI-visit till results of radical prostatectomy is known or till up to 2 years after MRI-visit
Features of prostate cancer differentiation grade on MRI
Time frame: From MRI-visit till results of radical prostatectomy is known or till up to 2 years after MRI-visit
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Background: PubMed 27568654Mottet N, Bellmunt J, Bolla M, Briers E, Cumberbatch MG, De Santis M, Fossati N, Gross T, Henry AM, Joniau S, Lam TB, Mason MD, Matveev VB, Moldovan PC, van den Bergh RCN, Van den Broeck T, van der Poel HG, van der Kwast TH, Rouviere O, Schoots IG, Wiegel T, Cornford P. EAU-ESTRO-SIOG Guidelines on Prostate Cancer. Part 1: Screening, Diagnosis, and Local Treatment with Curative Intent. Eur Urol. 2017 Apr;71(4):618-629. doi: 10.1016/j.eururo.2016.08.003. Epub 2016 Aug 25.
- Background: PubMed 25656808Futterer JJ, Briganti A, De Visschere P, Emberton M, Giannarini G, Kirkham A, Taneja SS, Thoeny H, Villeirs G, Villers A. Can Clinically Significant Prostate Cancer Be Detected with Multiparametric Magnetic Resonance Imaging? A Systematic Review of the Literature. Eur Urol. 2015 Dec;68(6):1045-53. doi: 10.1016/j.eururo.2015.01.013. Epub 2015 Feb 2.
- Background: PubMed 28110982Ahmed HU, El-Shater Bosaily A, Brown LC, Gabe R, Kaplan R, Parmar MK, Collaco-Moraes Y, Ward K, Hindley RG, Freeman A, Kirkham AP, Oldroyd R, Parker C, Emberton M; PROMIS study group. Diagnostic accuracy of multi-parametric MRI and TRUS biopsy in prostate cancer (PROMIS): a paired validating confirmatory study. Lancet. 2017 Feb 25;389(10071):815-822. doi: 10.1016/S0140-6736(16)32401-1. Epub 2017 Jan 20.
- Background: PubMed 30089067Kasivisvanathan V, Emberton M, Moore CM. MRI-Targeted Biopsy for Prostate-Cancer Diagnosis. N Engl J Med. 2018 Aug 9;379(6):589-590. doi: 10.1056/NEJMc1807507. No abstract available.
- Background: PubMed 22743165Moore CM, Robertson NL, Arsanious N, Middleton T, Villers A, Klotz L, Taneja SS, Emberton M. Image-guided prostate biopsy using magnetic resonance imaging-derived targets: a systematic review. Eur Urol. 2013 Jan;63(1):125-40. doi: 10.1016/j.eururo.2012.06.004. Epub 2012 Jun 13.
- Background: PubMed 24298917Logan JK, Rais-Bahrami S, Turkbey B, Gomella A, Amalou H, Choyke PL, Wood BJ, Pinto PA. Current status of magnetic resonance imaging (MRI) and ultrasonography fusion software platforms for guidance of prostate biopsies. BJU Int. 2014 Nov;114(5):641-52. doi: 10.1111/bju.12593. Epub 2014 May 22.
- Background: PubMed 24262102Wysock JS, Rosenkrantz AB, Huang WC, Stifelman MD, Lepor H, Deng FM, Melamed J, Taneja SS. A prospective, blinded comparison of magnetic resonance (MR) imaging-ultrasound fusion and visual estimation in the performance of MR-targeted prostate biopsy: the PROFUS trial. Eur Urol. 2014 Aug;66(2):343-51. doi: 10.1016/j.eururo.2013.10.048. Epub 2013 Nov 8.
- Background: PubMed 23579051Puech P, Rouviere O, Renard-Penna R, Villers A, Devos P, Colombel M, Bitker MO, Leroy X, Mege-Lechevallier F, Comperat E, Ouzzane A, Lemaitre L. Prostate cancer diagnosis: multiparametric MR-targeted biopsy with cognitive and transrectal US-MR fusion guidance versus systematic biopsy--prospective multicenter study. Radiology. 2013 Aug;268(2):461-9. doi: 10.1148/radiol.13121501. Epub 2013 Apr 11.
- Background: PubMed 23537686Moore CM, Kasivisvanathan V, Eggener S, Emberton M, Futterer JJ, Gill IS, Grubb Iii RL, Hadaschik B, Klotz L, Margolis DJ, Marks LS, Melamed J, Oto A, Palmer SL, Pinto P, Puech P, Punwani S, Rosenkrantz AB, Schoots IG, Simon R, Taneja SS, Turkbey B, Ukimura O, van der Meulen J, Villers A, Watanabe Y; START Consortium. Standards of reporting for MRI-targeted biopsy studies (START) of the prostate: recommendations from an International Working Group. Eur Urol. 2013 Oct;64(4):544-52. doi: 10.1016/j.eururo.2013.03.030. Epub 2013 Mar 20.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Cindy Mai, MD principal investigator
University Hospital Leuven, Department of Radiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI-targeted prostate biopsy in people with Prostate Cancer and Prostate Neoplasm, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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 5 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cindy Mai, MD (016345032 ext. 016345032, cindy.mai@uzleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of the two MR-guided registration techniques (visual and software-based) in the detection of clinically significant prostate cancer (time frame: From MRI-visit till results of radical prostatectomy is known or till up to 2 years after MRI-visit). 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 NCT03819751, which also lists 9 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 3 Jul 2024.