Advanced Prostate CancerWISENCT04117594
Whole Body Magnetic Resonance Imaging Study
An observational study of Advanced Prostate Cancer, run by Royal Marsden NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
In prostate cancer bone is the most common site for cancer spread, causing pain, fractures, nerve compression and death. New therapies are available for treating bone disease from cancer and this means that by maintaining patients on drugs that are effective and switching patients to other drugs when current treatment… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Advanced Prostate Cancer
- What is being tested?
- WB-MRI
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 9 Oct 2019to Jun 2021
- 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: Advanced prostate cancer patients with bone predominant metastases and no RECIST-measurable disease (lymph nodes <1.5cm in short axis in the pelvis are allowed) who have an indication for systemic treatment (taxane chemotherapy or AR targeted agents).
Who may be able to join
- Written informed consent
- Age ≥18 years
- Patients with APC with predominantly bone disease confirmed by bone scan (within 6 weeks) or CT (within 6 weeks), of starting treatment (Cycle 1 Day 1). Patients with local recurrence and bone metastases with an associated soft tissue component, will be allowed into the trial. Pelvic lymphadenopathy <1.5cm in short axis is not an exclusion.
- Systemic therapy indicated for disease progression, as clinically indicated.
Who cannot join
- Patient is claustrophobic.
- Contraindications to MRI examination (e.g. cardiac pacemakers, cochlear implants).
- Measurable soft tissue or lymph node metastases or any metastatic disease outside the bone that is RECIST measurable will be an exclusion (unless it is pelvic nodal disease <1.5cm in short axis). Bone metastases with associated soft tissue components will also not be an exclusion.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
The Royal Marsden NHS Foundation Trust
Sutton, Surrey, SM2 5PT
About this study
In prostate cancer bone is the most common site for cancer spread, causing pain, fractures, nerve compression and death.
New therapies are available for treating bone disease from cancer and this means that by maintaining patients on drugs that are effective and switching patients to other drugs when current treatment becomes ineffective, patients can be maintained 'better for longer'. However, to do this, it is necessary to accurately tell whether a given treatment is working or not.
In this study, the investigators will perform whole body MRI scans, which include a special scan called diffusion-weighted MRI (DWI MRI) that can provide more information about the participants extent of disease. The investigators aim to show that this test is better than the standard tests of CT and bone scan currently used in the NHS to monitor bone disease. The information from this study will be used to test a special software so that the test may more widely benefit patients across the NHS in the future.
Read the detailed description
In patients with prostate cancer the current methods to assess treatment response of bone disease such as computer tomography (CT) and bone scan (BS)are unreliable, insensitive to bone disease and have limited criteria to assess disease response confined to bones. Blood tests are inaccurate although some newer tests (e.g. circulating tumour cells tests) show promise but are still under investigation and nuclear medicine investigations such as PET/CT imaging have higher sensitivity, meaning they can detect more sites of disease who are indeed disease than CT or BS but they are more costly and less widely available compared with MRI within the NHS.
For this study the Whole body MRI (WB-MRI) includes a measurement called diffusion-weighted imaging (DWI) which is relatively new and has a high sensitivity for bone metastases. This technique can be used to measure total bone disease volume (TDV) and the disease apparent diffusion coefficient (ADC) which reflects the tumour tissue cell density. Previous studies have shown good reproducibility of both these measurements and a significant increase in the mean tumour ADC is observed in patients who are responding to effective treatment.
However WB-MRI application across the NHS is ad-hoc, CT and BS techniques are entrenched within clinical practice despite their known limitations. Another factor that limits wider adoption of WB-MRI is the lack of sophisticated analysis software to enable disease across the body to be quickly evaluated.
This multi-centre imaging study will provide the opportunity to evaluate the performance of WB-MRI with a novel software diagnostics for evaluating the treatment response of advanced prostate cancer patients.
This prototype can used to evaluate WB-MRI data from different scanners and address a current major unmet need for the treatment and follow-up of patients with bone disease from cancers, so that the test may more widely benefit patients across the NHS in the future.
- Conditions
- Advanced Prostate Cancer
- Being tested
- WB-MRI
- Keywords
- Prostate cancer, WB-MRI, Bone disease
- Medical subject headings
- Prostatic Neoplasms, Bone Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WB-MRIDiagnostic test
Whole body MRI with diffusion-weighted imaging (DWI)
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic performance of WB MRI at post treatment by quantification of bone disease
To establish the diagnostic performance of whole body MRI (WB MRI) using total bone disease volume (TDV) and disease apparent diffusion coefficient (ADC) at Cycle 3 (within 2 weeks before treatment on C4 Day1, each cycle being 28 days or 21 days depending on the type of standard therapy) using new software diagnostics for assessing treatment response to standard therapy (taxane chemotherapy or AR targeted agents)) in patients with bone predominant metastatic disease in prostate cancer using a construct reference standard.
Measured: End of Cycle 3 of treatment (each cycle being 28 days or 21 days depending on the type of standard therapy)
Secondary outcomes (4)
Compare diagnostic performance of WB-MRI at Cycle 3 versus standard imaging CT and bone scan by quantification of bone disease
Compare the diagnostic performance of WB-MRI using TDV and ADC at Cycle 3 (within 2 weeks before treatment on C4 Day1, each cycle being 28 or 21 days depending on the type of standard therapy) with the diagnostic performance of standard imaging CT and BS (when available).
Measured: End of Cycle 3 of treatment (each cycle being 28 days or 21 days depending on the type of standard therapy)
Time to progression of responders and non-responders
Determine the time to progression of responders and non-responders to therapy as defined by WB MRI, versus CT and BS.
Measured: 6 months
Intra-observer and inter-observer agreement of ADC and TDV
Assess the intra-observer and inter-observer agreement of the apparent diffusion coefficient (ADC) and total diffusion volume (TDV) of bone disease assessed by WB-MRI.
Measured: 1 year
Assess the cost-effectiveness of replacing CT and BS with WB-MRI derived measurements TDV and ADC
Determine the cost-effectiveness of replacing CT and BS with WB-MRI derived TDV and ADC measurements for disease management in patients with prostate bone disease using QALYs.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2019
- Study start9 Oct 2019
- Primary completionJun 2021 (estimated)
- Study completionJun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Prostate CancerStudies of the same condition, open and under way.
- More trials run by Royal Marsden NHS Foundation TrustThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal Marsden NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom, Institute of Cancer Research, United Kingdom
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04117594
- Sponsor's protocol ID
- CCR 5035
- Acronym
- WISE
- Status last verified
- May 2021
- First submitted
- 26 Sep 2019
- Last updated
- 19 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Fully anonymised trial data will be made available
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Whole Body Magnetic Resonance Imaging Study
- ClinicalTrials.gov ID
- NCT04117594
- Acronym / sponsor ID
- WISE / CCR 5035
- Conditions
- Advanced Prostate Cancer
- Keywords
- Prostate cancer, WB-MRI, Bone disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Royal Marsden NHS Foundation TrustUniversity, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom, Institute of Cancer Research, United Kingdom
- Study start
- 9 Oct 2019 (actual)
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 7 Oct 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.
In prostate cancer bone is the most common site for cancer spread, causing pain, fractures, nerve compression and death.
New therapies are available for treating bone disease from cancer and this means that by maintaining patients on drugs that are effective and switching patients to other drugs when current treatment becomes ineffective, patients can be maintained 'better for longer'. However, to do this, it is necessary to accurately tell whether a given treatment is working or not.
In this study, the investigators will perform whole body MRI scans, which include a special scan called diffusion-weighted MRI (DWI MRI) that can provide more information about the participants extent of disease. The investigators aim to show that this test is better than the standard tests of CT and bone scan currently used in the NHS to monitor bone disease. The information from this study will be used to test a special software so that the test may more widely benefit patients across the NHS in the future.
Detailed description
In patients with prostate cancer the current methods to assess treatment response of bone disease such as computer tomography (CT) and bone scan (BS)are unreliable, insensitive to bone disease and have limited criteria to assess disease response confined to bones. Blood tests are inaccurate although some newer tests (e.g. circulating tumour cells tests) show promise but are still under investigation and nuclear medicine investigations such as PET/CT imaging have higher sensitivity, meaning they can detect more sites of disease who are indeed disease than CT or BS but they are more costly and less widely available compared with MRI within the NHS.
For this study the Whole body MRI (WB-MRI) includes a measurement called diffusion-weighted imaging (DWI) which is relatively new and has a high sensitivity for bone metastases. This technique can be used to measure total bone disease volume (TDV) and the disease apparent diffusion coefficient (ADC) which reflects the tumour tissue cell density. Previous studies have shown good reproducibility of both these measurements and a significant increase in the mean tumour ADC is observed in patients who are responding to effective treatment.
However WB-MRI application across the NHS is ad-hoc, CT and BS techniques are entrenched within clinical practice despite their known limitations. Another factor that limits wider adoption of WB-MRI is the lack of sophisticated analysis software to enable disease across the body to be quickly evaluated.
This multi-centre imaging study will provide the opportunity to evaluate the performance of WB-MRI with a novel software diagnostics for evaluating the treatment response of advanced prostate cancer patients.
This prototype can used to evaluate WB-MRI data from different scanners and address a current major unmet need for the treatment and follow-up of patients with bone disease from cancers, so that the test may more widely benefit patients across the NHS in the future.
Study design
- Observational model
- Other
- 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
- Advanced prostate cancer patients with bone predominant metastases and no RECIST-measurable disease (lymph nodes <1.5cm in short axis in the pelvis are allowed) who have an indication for systemic treatment (taxane chemotherapy or AR targeted agents).
Key inclusion criteria (4 listed)
- Written informed consent
- Age ≥18 years
- Patients with APC with predominantly bone disease confirmed by bone scan (within 6 weeks) or CT (within 6 weeks), of starting treatment (Cycle 1 Day 1). Patients with local recurrence and bone metastases with an associated soft tissue component, will be allowed into the trial. Pelvic lymphadenopathy <1.5cm in short axis is not an exclusion.
- Systemic therapy indicated for disease progression, as clinically indicated.
Key exclusion criteria (3 listed)
- Patient is claustrophobic.
- Contraindications to MRI examination (e.g. cardiac pacemakers, cochlear implants).
- Measurable soft tissue or lymph node metastases or any metastatic disease outside the bone that is RECIST measurable will be an exclusion (unless it is pelvic nodal disease <1.5cm in short axis). Bone metastases with associated soft tissue components will also not be an exclusion.
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 |
|---|---|---|
| WB-MRIWhole body MRI with diffusion-weighted imaging (DWI) | Diagnostic test | – |
Primary outcome
Diagnostic performance of WB MRI at post treatment by quantification of bone disease
Time frame: End of Cycle 3 of treatment (each cycle being 28 days or 21 days depending on the type of standard therapy)
To establish the diagnostic performance of whole body MRI (WB MRI) using total bone disease volume (TDV) and disease apparent diffusion coefficient (ADC) at Cycle 3 (within 2 weeks before treatment on C4 Day1, each cycle being 28 days or 21 days depending on the type of standard therapy) using new software diagnostics for assessing treatment response to standard therapy (taxane chemotherapy or AR targeted agents)) in patients with bone predominant metastatic disease in prostate cancer using a construct reference standard.
4 secondary outcomes
Compare diagnostic performance of WB-MRI at Cycle 3 versus standard imaging CT and bone scan by quantification of bone disease
Time frame: End of Cycle 3 of treatment (each cycle being 28 days or 21 days depending on the type of standard therapy)
Time to progression of responders and non-responders
Time frame: 6 months
Intra-observer and inter-observer agreement of ADC and TDV
Time frame: 1 year
Assess the cost-effectiveness of replacing CT and BS with WB-MRI derived measurements TDV and ADC
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2021.
- Individual participant dataSharing planned: Yes. Fully anonymised trial data will be made available
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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.
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 Advanced Prostate Cancer, run by Royal Marsden NHS Foundation Trust 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 4 inclusion and 3 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 19 May 2021. 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?
Results are not available in the source record.
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 performance of WB MRI at post treatment by quantification of bone disease (time frame: End of Cycle 3 of treatment (each cycle being 28 days or 21 days depending on the type of standard therapy)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 May 2021.