Prostate CancerINNOVATENCT02689271
CombIning advaNces in imagiNg With biOmarkers for improVed Diagnosis of Aggressive prosTate cancEr
An observational study of Prostate Cancer, run by University College, London at 1 site in United Kingdom.
Trial summary
To enable the paradigm of mp-MRI before biopsy in all patients with suspected prostate cancer by better selecting patients who will benefit from diagnostic MRI and by improving the performance of the mp-MRI itself Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- MRI
- How many people
- 365 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2016to Dec 2019
- Phase
- Observational
- 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
Study population: Men with suspected prostate cancer
Who may be able to join
- Men referred to University College London Hospital (UCLH) for prostate mp-MRI following biopsy elsewhere and biopsy naive men presenting to UCLH with a clinical suspicion of prostate cancer.
Who cannot join
- Men unable to have a MRI scan, or in whom artefact would reduce quality of MRI
- Men unable to given informed consent
- Previous treatment (prostatectomy, radiotherapy, brachytherapy) of prostate cancer
- On-going hormonal treatment for prostate cancer
- Previous biopsy within 6 months of scheduled mp-MRI
Trial locations and contacts
1 site in 1 country.
About this study
To enable the paradigm of mp-MRI before biopsy in all patients with suspected prostate cancer by better selecting patients who will benefit from diagnostic MRI and by improving the performance of the mp-MRI itself
Read the detailed description
Patients will undergo an advanced diffusion-weighted MRI sequence called VERDICT with the intention of better characterising prostate cancer. A panel of serum and urine biomarkers will also be analysed, which we hope will predict those patients who go on have a positive MRI.
OBJECTIVES:
- To establish a fluidic marker - prostate MRI paradigm which: (i) utilises fluidic markers to rationalise selection of patients with significant prostate cancer; and (ii) improves the diagnostic accuracy of imaging over and above standard multiparametric (mp) MRI
- Enable a pathway for rapid clinical evaluation of emerging fluidic markers and exosomes
- Assess the repeatability of VERDICT MRI
- Ascertain whether VERDICT derived quantitative parameters correlate with quantitative histological parameters
- Develop a database of fluidic marker and VERDICT characterised, mp-MRI, histologically validated patients for subsequent exploratory and longitudinal outcome analysis
- Conditions
- Prostate Cancer
- Being tested
- MRI
- Keywords
- MRI, Magnetic resonance imaging, Biomarkers, Fluidics, Diffusion MRI
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIOther
VERDICT diffusion-weighted microstructure imaging sequence
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy of VERDICT MRI
Radiological assessment with added VERDICT MRI improves the specificity of mp-MRI for detection of significant prostate cancer by >10% above standard multi-parametric MRI alone.
Measured: 3 - 6 months (after targeted biopsy or follow up MRI)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2016 (estimated)
- Study startApr 2016
- Primary completionDec 2019
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 University College, LondonThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 365 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02689271
- Sponsor's protocol ID
- 15/0692
- Acronym
- INNOVATE
- Status last verified
- Mar 2020
- First submitted
- 12 Feb 2016
- Last updated
- 27 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Singh S, Rogers H, Kanber B, Clemente J, Pye H, Johnston EW, Parry T, Grey A, Dinneen E, Shaw G, Heavey S, Stopka-Farooqui U, Haider A, Freeman A, Giganti F, Atkinson D, Moore CM, Whitaker HC, Alexander DC, Panagiotaki E, Punwani S. Avoiding Unnecessary Biopsy after Multiparametric Prostate MRI with VERDICT Analysis: The INNOVATE Study. Radiology. 2022 Dec;305(3):623-630. doi: 10.1148/radiol.212536. Epub 2022 Aug 2.
PubMed 35916679Johnston E, Pye H, Bonet-Carne E, Panagiotaki E, Patel D, Galazi M, Heavey S, Carmona L, Freeman A, Trevisan G, Allen C, Kirkham A, Burling K, Stevens N, Hawkes D, Emberton M, Moore C, Ahmed HU, Atkinson D, Rodriguez-Justo M, Ng T, Alexander D, Whitaker H, Punwani S. INNOVATE: A prospective cohort study combining serum and urinary biomarkers with novel diffusion-weighted magnetic resonance imaging for the prediction and characterization of prostate cancer. BMC Cancer. 2016 Oct 21;16(1):816. doi: 10.1186/s12885-016-2856-2.
PubMed 27769214
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CombIning advaNces in imagiNg With biOmarkers for improVed Diagnosis of Aggressive prosTate cancEr
- ClinicalTrials.gov ID
- NCT02689271
- Acronym / sponsor ID
- INNOVATE / 15/0692
- Conditions
- Prostate Cancer
- Keywords
- MRI, Magnetic resonance imaging, Biomarkers, Fluidics, Diffusion MRI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 365 participants (actual)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Study start
- Apr 2016 (actual)
- Primary completion
- Dec 2019 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 23 Feb 2016 (estimated)
- 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.
To enable the paradigm of mp-MRI before biopsy in all patients with suspected prostate cancer by better selecting patients who will benefit from diagnostic MRI and by improving the performance of the mp-MRI itself
Detailed description
Patients will undergo an advanced diffusion-weighted MRI sequence called VERDICT with the intention of better characterising prostate cancer. A panel of serum and urine biomarkers will also be analysed, which we hope will predict those patients who go on have a positive MRI.
OBJECTIVES:
- To establish a fluidic marker - prostate MRI paradigm which: (i) utilises fluidic markers to rationalise selection of patients with significant prostate cancer; and (ii) improves the diagnostic accuracy of imaging over and above standard multiparametric (mp) MRI
- Enable a pathway for rapid clinical evaluation of emerging fluidic markers and exosomes
- Assess the repeatability of VERDICT MRI
- Ascertain whether VERDICT derived quantitative parameters correlate with quantitative histological parameters
- Develop a database of fluidic marker and VERDICT characterised, mp-MRI, histologically validated patients for subsequent exploratory and longitudinal outcome analysis
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Men with suspected prostate cancer
Key inclusion criteria (1 listed)
- Men referred to University College London Hospital (UCLH) for prostate mp-MRI following biopsy elsewhere and biopsy naive men presenting to UCLH with a clinical suspicion of prostate cancer.
Key exclusion criteria (5 listed)
- Men unable to have a MRI scan, or in whom artefact would reduce quality of MRI
- Men unable to given informed consent
- Previous treatment (prostatectomy, radiotherapy, brachytherapy) of prostate cancer
- On-going hormonal treatment for prostate cancer
- Previous biopsy within 6 months of scheduled mp-MRI
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 |
|---|---|---|
| MRIVERDICT diffusion-weighted microstructure imaging sequence | Other | – |
Primary outcome
Diagnostic accuracy of VERDICT MRI
Time frame: 3 - 6 months (after targeted biopsy or follow up MRI)
Radiological assessment with added VERDICT MRI improves the specificity of mp-MRI for detection of significant prostate cancer by >10% above standard multi-parametric MRI alone.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2020.
- Derived from this study: PubMed 35916679Singh S, Rogers H, Kanber B, Clemente J, Pye H, Johnston EW, Parry T, Grey A, Dinneen E, Shaw G, Heavey S, Stopka-Farooqui U, Haider A, Freeman A, Giganti F, Atkinson D, Moore CM, Whitaker HC, Alexander DC, Panagiotaki E, Punwani S. Avoiding Unnecessary Biopsy after Multiparametric Prostate MRI with VERDICT Analysis: The INNOVATE Study. Radiology. 2022 Dec;305(3):623-630. doi: 10.1148/radiol.212536. Epub 2022 Aug 2.
- Derived from this study: PubMed 27769214Johnston E, Pye H, Bonet-Carne E, Panagiotaki E, Patel D, Galazi M, Heavey S, Carmona L, Freeman A, Trevisan G, Allen C, Kirkham A, Burling K, Stevens N, Hawkes D, Emberton M, Moore C, Ahmed HU, Atkinson D, Rodriguez-Justo M, Ng T, Alexander D, Whitaker H, Punwani S. INNOVATE: A prospective cohort study combining serum and urinary biomarkers with novel diffusion-weighted magnetic resonance imaging for the prediction and characterization of prostate cancer. BMC Cancer. 2016 Oct 21;16(1):816. doi: 10.1186/s12885-016-2856-2.
- Individual participant dataSharing planned: No
Related trials for Prostate Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Active, not recruitingObservational study
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
Prostate Cancer
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by University College, London at 1 site in United Kingdom.
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 1 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: finished, as of the sponsor's last update on 27 Mar 2020. 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 United Kingdom. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy of VERDICT MRI (time frame: 3 - 6 months (after targeted biopsy or follow up MRI)). 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 NCT02689271, which also lists 2 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 27 Mar 2020.