Prostate CancerNCT03101176
Multiparametric Ultrasound Imaging in Prostate Cancer
A study testing SonoVue in people with Prostate Cancer and Prostatic Neoplasms, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
Trial summary
Rationale: The current limitations in prostate cancer diagnostics, due to lack of accuracy of the available techniques, lead to over- and undertreatment for a significant fraction of patients with prostate cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer, Prostatic Neoplasms
- What is being tested?
- SonoVue
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteNetherlands
- Study dates
- 7 Sep 2017to 1 Sep 2022
- 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age ≥ 18 years
- biopsy proven prostate carcinoma
- planned treatment by (robot laparoscopic) radical prostatectomy
- signed informed consent
Who cannot join
- Chemotherapy, radiotherapy or focal therapy of the prostate for prostate cancer
- Hormonal therapy for prostate cancer within last six months
- History of any clinically evidence of cardiac right-to-left shunts
- Receives treatment that includes dobutamine
- Severe pulmonary hypertension (pulmonary artery pressure >90 mmHg) or uncontrolled systemic hypertension or respiratory distress syndrome
- Has any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data, achieving study objectives, or completing the study
- Is incapable of understanding the language in which the information for the patient is given
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
AMC University Hospital
Amsterdam, 1105 AZ
H. Wijkstra, Prof dr ir, +31 20 5666379, h.wijkstra@amc.uva.nl
About this study
Official title: Multiparametric Ultrasound (mpUS) as Imaging Modality for the Detection and Localization of Prostate Cancer
Rationale: The current limitations in prostate cancer diagnostics, due to lack of accuracy of the available techniques, lead to over- and undertreatment for a significant fraction of patients with prostate cancer. Multiparametric ultrasound (mpUS), a new imaging modality combining different ultrasound parameters, heralds the potential for an accurate imaging-based diagnostic approach accessible to the community at large but formal validation of mpUS against final pathology results are still lacking.
Objective: To validate mpUS as imaging modality for detection and localization of prostate cancer by direct correlation with histopathology of radical prostatectomy specimens
Read the detailed description
Systematic transrectal ultrasound (TRUS)-guided biopsies in men with a clinical suspicion of prostate cancer, based on digital rectal examination (DRE) and/or prostate-specific antigen (PSA) has been the diagnostic strategy for years. However, this method has known limited sensitivity and risks, as many men without cancer undergo unnecessary biopsies, clinically insignificant cancers are often detected while significant cancers are missed or under-graded and the biopsy procedure itself carries discomfort and morbidity. Prostate imaging capable of identifying clinically significant disease for targeted biopsy with high accuracy and efficiency is thus of importance. mpMRI (multiparametric magnetic resonance imaging) and mpMRI-targeted biopsies are being increasingly used, and they have improved the ability to detect clinically significant cancers, while reducing the diagnosis of insignificant cancers compared to TRUS-guided biopsies. Nevertheless, mpMRI has been limited by inter-reader variability, high level of expertise requirements and heterogeneity in definitions while mpMRI-targeted biopsies alone still misses clinical significant cancers revealed by TRUS-guided biopsies.
There is an ongoing search for new cost-effective, manageable imaging technologies for adequate prostate cancer diagnosis. Various ultrasound modalities are in development striving to increase cancer detection among which contrast-enhanced ultrasound (CEUS) and elastography. Preliminary results of a multiparametric ultrasound (mpUS) approach, combining these different ultrasound modalities, seem promising. The number and quality of studies available, however, is relatively low, emphasizing the need for further work to define the role of mpUS.
This is an investigator-initiated, prospective in-vivo validation study in humans to validate mpUS as imaging modality for detection and localization of prostate cancer by direct correlation with histopathology. Biopsy-proven prostate cancer patients scheduled for radical prostatectomy will be approached and consented to enter this study. Information about the study will be provided both verbally and in written form.
Participants will undergo a mpUS imaging prior to their surgery. For the contrast enhanced mode of the mpUS an additional infusion of an ultrasound contrast agent through an intravenous cannula will be used during transrectal ultrasound scanning for the purpose of the study.
The mpUS imaging data will be evaluated qualitatively and semi-quantitatively using parametric maps by prostate ultrasound experts blinded for radical prostatectomy histopathology. Histopathology will be evaluated qualitatively by an uro-pathologist blinded for mpUS imaging results. Hence, imaging data will be correlated with histopathology in a blinded fashion using a 3D registration system and 3D reconstruction model. Predictive accuracy of mpUS imaging for detection and localization of prostate cancer on histopathology will be analyzed.
At a later stage, a mpUS classifier, most optimally combining the most relevant ultrasound parameters of each modality in one single resulting mpUS parameter will be developed. Furthermore, the additional clinical value of mpUS imaging in prostate cancer diagnostics will be determined by comparing mpUS results with that of available mpMRI data. mpMRI imaging data will be evaluated by an uro-radiologist using the PI-RADS (Prostate Imaging Reporting and Data System) criteria blinded for radical prostatectomy results.
- Conditions
- Prostate Cancer, Prostatic Neoplasms
- Being tested
- SonoVue
- Keywords
- multiparametric ultrasound, prostate cancer, contrast ultrasound, CEUS, radical prostatectomy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SonoVueDrug
Also called sulphur hexafluoride
The ultrasound contrast agent used for the CEUS specific ultrasound mode
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Single Arm | Experimental | All consenting patients will undergo mpUS imaging prior to surgery with the ultrasound contrast agent Sonovue for the CEUS specific mode. Receives: Drug: SonoVue |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validation of mpUS
Predictive accuracy in terms of sensitivity and specificity of mpUS imaging in the detection and localization of prostate cancer by qualitatively and semi-quantitatively correlation of mpUS imaging to corresponding radical prostatectomy histopathology
Measured: 5 years
Secondary outcomes (2)
Differences in mpUS parameters between benign and malignant (low-grade and high-grade) prostate tissue
Parameters of mpUS (echogenicity, contrast-agent perfusion, contrast-agent dispersion, contrast-agent velocity, tissuedensity) will be assessed
Measured: 5 years
mpUS and mpMRI comparison
Comparison of predictive accuracy in terms of sensitivity and specificity of mpMRI imaging and mpUS imaging
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2017
- Study start7 Sep 2017
- Primary completion1 Sep 2022 (estimated)
- Study completion1 Sep 2022 (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 Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The 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
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Amsterdam UMC, location VUmc
- Responsible party
- Principal investigator, Prof. dr. ir. H. Wijkstra, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- H. Wijkstra, Prof dr ir, Principal investigator, AMC University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03101176
- Sponsor's protocol ID
- NL58710.018.07
- Status last verified
- Jan 2019
- First submitted
- 23 Mar 2017
- Last updated
- 17 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bjurlin MA, Carter HB, Schellhammer P, Cookson MS, Gomella LG, Troyer D, Wheeler TM, Schlossberg S, Penson DF, Taneja SS. Optimization of initial prostate biopsy in clinical practice: sampling, labeling and specimen processing. J Urol. 2013 Jun;189(6):2039-46. doi: 10.1016/j.juro.2013.02.072. Epub 2013 Feb 26.
PubMed 23485507Ukimura O, Coleman JA, de la Taille A, Emberton M, Epstein JI, Freedland SJ, Giannarini G, Kibel AS, Montironi R, Ploussard G, Roobol MJ, Scattoni V, Jones JS. Contemporary role of systematic prostate biopsies: indications, techniques, and implications for patient care. Eur Urol. 2013 Feb;63(2):214-30. doi: 10.1016/j.eururo.2012.09.033. Epub 2012 Sep 25.
PubMed 23021971Borghesi M, Ahmed H, Nam R, Schaeffer E, Schiavina R, Taneja S, Weidner W, Loeb S. Complications After Systematic, Random, and Image-guided Prostate Biopsy. Eur Urol. 2017 Mar;71(3):353-365. doi: 10.1016/j.eururo.2016.08.004. Epub 2016 Aug 17.
PubMed 27543165Schoots IG, Roobol MJ, Nieboer D, Bangma CH, Steyerberg EW, Hunink MG. Magnetic resonance imaging-targeted biopsy may enhance the diagnostic accuracy of significant prostate cancer detection compared to standard transrectal ultrasound-guided biopsy: a systematic review and meta-analysis. Eur Urol. 2015 Sep;68(3):438-50. doi: 10.1016/j.eururo.2014.11.037. Epub 2014 Dec 3.
PubMed 25480312Muller BG, Shih JH, Sankineni S, Marko J, Rais-Bahrami S, George AK, de la Rosette JJ, Merino MJ, Wood BJ, Pinto P, Choyke PL, Turkbey B. Prostate Cancer: Interobserver Agreement and Accuracy with the Revised Prostate Imaging Reporting and Data System at Multiparametric MR Imaging. Radiology. 2015 Dec;277(3):741-50. doi: 10.1148/radiol.2015142818. Epub 2015 Jun 18.
PubMed 26098458Branger N, Maubon T, Traumann M, Thomassin-Piana J, Brandone N, Taix S, Touzlian J, Brunelle S, Pignot G, Salem N, Gravis G, Walz J. Is negative multiparametric magnetic resonance imaging really able to exclude significant prostate cancer? The real-life experience. BJU Int. 2017 Mar;119(3):449-455. doi: 10.1111/bju.13657. Epub 2016 Oct 4.
PubMed 27618134Mottet 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 27568654Grey A, Ahmed HU. Multiparametric ultrasound in the diagnosis of prostate cancer. Curr Opin Urol. 2016 Jan;26(1):114-9. doi: 10.1097/MOU.0000000000000245.
PubMed 26555694Postema A, Mischi M, de la Rosette J, Wijkstra H. Multiparametric ultrasound in the detection of prostate cancer: a systematic review. World J Urol. 2015 Nov;33(11):1651-9. doi: 10.1007/s00345-015-1523-6. Epub 2015 Mar 12.
PubMed 25761736
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multiparametric Ultrasound (mpUS) as Imaging Modality for the Detection and Localization of Prostate Cancer
- ClinicalTrials.gov ID
- NCT03101176
- Acronym / sponsor ID
- NL58710.018.07
- Conditions
- Prostate Cancer, Prostatic Neoplasms
- Keywords
- multiparametric ultrasound, prostate cancer, contrast ultrasound, CEUS, radical prostatectomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Collaborators
- Amsterdam UMC, location VUmc
- Study start
- 7 Sep 2017 (actual)
- Primary completion
- 1 Sep 2022 (estimated)
- Study completion
- 1 Sep 2022 (estimated)
- First posted
- 5 Apr 2017 (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.
Rationale: The current limitations in prostate cancer diagnostics, due to lack of accuracy of the available techniques, lead to over- and undertreatment for a significant fraction of patients with prostate cancer. Multiparametric ultrasound (mpUS), a new imaging modality combining different ultrasound parameters, heralds the potential for an accurate imaging-based diagnostic approach accessible to the community at large but formal validation of mpUS against final pathology results are still lacking.
Objective: To validate mpUS as imaging modality for detection and localization of prostate cancer by direct correlation with histopathology of radical prostatectomy specimens
Detailed description
Systematic transrectal ultrasound (TRUS)-guided biopsies in men with a clinical suspicion of prostate cancer, based on digital rectal examination (DRE) and/or prostate-specific antigen (PSA) has been the diagnostic strategy for years. However, this method has known limited sensitivity and risks, as many men without cancer undergo unnecessary biopsies, clinically insignificant cancers are often detected while significant cancers are missed or under-graded and the biopsy procedure itself carries discomfort and morbidity. Prostate imaging capable of identifying clinically significant disease for targeted biopsy with high accuracy and efficiency is thus of importance. mpMRI (multiparametric magnetic resonance imaging) and mpMRI-targeted biopsies are being increasingly used, and they have improved the ability to detect clinically significant cancers, while reducing the diagnosis of insignificant cancers compared to TRUS-guided biopsies. Nevertheless, mpMRI has been limited by inter-reader variability, high level of expertise requirements and heterogeneity in definitions while mpMRI-targeted biopsies alone still misses clinical significant cancers revealed by TRUS-guided biopsies.
There is an ongoing search for new cost-effective, manageable imaging technologies for adequate prostate cancer diagnosis. Various ultrasound modalities are in development striving to increase cancer detection among which contrast-enhanced ultrasound (CEUS) and elastography. Preliminary results of a multiparametric ultrasound (mpUS) approach, combining these different ultrasound modalities, seem promising. The number and quality of studies available, however, is relatively low, emphasizing the need for further work to define the role of mpUS.
This is an investigator-initiated, prospective in-vivo validation study in humans to validate mpUS as imaging modality for detection and localization of prostate cancer by direct correlation with histopathology. Biopsy-proven prostate cancer patients scheduled for radical prostatectomy will be approached and consented to enter this study. Information about the study will be provided both verbally and in written form.
Participants will undergo a mpUS imaging prior to their surgery. For the contrast enhanced mode of the mpUS an additional infusion of an ultrasound contrast agent through an intravenous cannula will be used during transrectal ultrasound scanning for the purpose of the study.
The mpUS imaging data will be evaluated qualitatively and semi-quantitatively using parametric maps by prostate ultrasound experts blinded for radical prostatectomy histopathology. Histopathology will be evaluated qualitatively by an uro-pathologist blinded for mpUS imaging results. Hence, imaging data will be correlated with histopathology in a blinded fashion using a 3D registration system and 3D reconstruction model. Predictive accuracy of mpUS imaging for detection and localization of prostate cancer on histopathology will be analyzed.
At a later stage, a mpUS classifier, most optimally combining the most relevant ultrasound parameters of each modality in one single resulting mpUS parameter will be developed. Furthermore, the additional clinical value of mpUS imaging in prostate cancer diagnostics will be determined by comparing mpUS results with that of available mpMRI data. mpMRI imaging data will be evaluated by an uro-radiologist using the PI-RADS (Prostate Imaging Reporting and Data System) criteria blinded for radical prostatectomy results.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental: Single Arm | Experimental | Drug: SonoVueAll consenting patients will undergo mpUS imaging prior to surgery with the ultrasound contrast agent Sonovue for the CEUS specific mode. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age ≥ 18 years
- biopsy proven prostate carcinoma
- planned treatment by (robot laparoscopic) radical prostatectomy
- signed informed consent
Key exclusion criteria (7 listed)
- Chemotherapy, radiotherapy or focal therapy of the prostate for prostate cancer
- Hormonal therapy for prostate cancer within last six months
- History of any clinically evidence of cardiac right-to-left shunts
- Receives treatment that includes dobutamine
- Severe pulmonary hypertension (pulmonary artery pressure >90 mmHg) or uncontrolled systemic hypertension or respiratory distress syndrome
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 |
|---|---|---|
| SonoVueAlso: sulphur hexafluorideThe ultrasound contrast agent used for the CEUS specific ultrasound mode | Drug | Experimental: Single Arm |
Primary outcome
Validation of mpUS
Time frame: 5 years
Predictive accuracy in terms of sensitivity and specificity of mpUS imaging in the detection and localization of prostate cancer by qualitatively and semi-quantitatively correlation of mpUS imaging to corresponding radical prostatectomy histopathology
2 secondary outcomes
Differences in mpUS parameters between benign and malignant (low-grade and high-grade) prostate tissue
Time frame: 5 years
mpUS and mpMRI comparison
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2019.
- Background: PubMed 23485507Bjurlin MA, Carter HB, Schellhammer P, Cookson MS, Gomella LG, Troyer D, Wheeler TM, Schlossberg S, Penson DF, Taneja SS. Optimization of initial prostate biopsy in clinical practice: sampling, labeling and specimen processing. J Urol. 2013 Jun;189(6):2039-46. doi: 10.1016/j.juro.2013.02.072. Epub 2013 Feb 26.
- Background: PubMed 23021971Ukimura O, Coleman JA, de la Taille A, Emberton M, Epstein JI, Freedland SJ, Giannarini G, Kibel AS, Montironi R, Ploussard G, Roobol MJ, Scattoni V, Jones JS. Contemporary role of systematic prostate biopsies: indications, techniques, and implications for patient care. Eur Urol. 2013 Feb;63(2):214-30. doi: 10.1016/j.eururo.2012.09.033. Epub 2012 Sep 25.
- Background: PubMed 27543165Borghesi M, Ahmed H, Nam R, Schaeffer E, Schiavina R, Taneja S, Weidner W, Loeb S. Complications After Systematic, Random, and Image-guided Prostate Biopsy. Eur Urol. 2017 Mar;71(3):353-365. doi: 10.1016/j.eururo.2016.08.004. Epub 2016 Aug 17.
- Background: PubMed 25480312Schoots IG, Roobol MJ, Nieboer D, Bangma CH, Steyerberg EW, Hunink MG. Magnetic resonance imaging-targeted biopsy may enhance the diagnostic accuracy of significant prostate cancer detection compared to standard transrectal ultrasound-guided biopsy: a systematic review and meta-analysis. Eur Urol. 2015 Sep;68(3):438-50. doi: 10.1016/j.eururo.2014.11.037. Epub 2014 Dec 3.
- Background: PubMed 26098458Muller BG, Shih JH, Sankineni S, Marko J, Rais-Bahrami S, George AK, de la Rosette JJ, Merino MJ, Wood BJ, Pinto P, Choyke PL, Turkbey B. Prostate Cancer: Interobserver Agreement and Accuracy with the Revised Prostate Imaging Reporting and Data System at Multiparametric MR Imaging. Radiology. 2015 Dec;277(3):741-50. doi: 10.1148/radiol.2015142818. Epub 2015 Jun 18.
- Background: PubMed 27618134Branger N, Maubon T, Traumann M, Thomassin-Piana J, Brandone N, Taix S, Touzlian J, Brunelle S, Pignot G, Salem N, Gravis G, Walz J. Is negative multiparametric magnetic resonance imaging really able to exclude significant prostate cancer? The real-life experience. BJU Int. 2017 Mar;119(3):449-455. doi: 10.1111/bju.13657. Epub 2016 Oct 4.
- 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 26555694Grey A, Ahmed HU. Multiparametric ultrasound in the diagnosis of prostate cancer. Curr Opin Urol. 2016 Jan;26(1):114-9. doi: 10.1097/MOU.0000000000000245.
- Background: PubMed 25761736Postema A, Mischi M, de la Rosette J, Wijkstra H. Multiparametric ultrasound in the detection of prostate cancer: a systematic review. World J Urol. 2015 Nov;33(11):1651-9. doi: 10.1007/s00345-015-1523-6. Epub 2015 Mar 12.
- 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.
H. Wijkstra, Prof dr ir principal investigator
AMC University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SonoVue in people with Prostate Cancer and Prostatic Neoplasms, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
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 7 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 17 Jan 2019. 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 Netherlands. 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 H. Wijkstra, Prof dr ir (+31 20 5666379, h.wijkstra@amc.uva.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validation of mpUS (time frame: 5 years). 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 NCT03101176, 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 17 Jan 2019.