Advanced Prostate CarcinomaIDTNCT04984395
Improving Diagnosis and Treatment of Metastatic Advanced Prostate Cancer
An observational study of Advanced Prostate Carcinoma, run by Royal Marsden NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
The aim of this study is to provide clinical evidence to determine if Whole Body Magnetic Resonance Imaging (WBMRI) with a novel technique called diffusion-weighted imaging (DWI) can improve current treatment for APC patients, allowing for early identification of disease progression or treatment response, hence… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Advanced Prostate Carcinoma
- What is being tested?
- Post-treatment CT-guided bone marrow biopsy
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 30 Jul 2021to 31 May 2024
- 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: Patients with metastatic, advanced prostate cancer.
Who may be able to join
- Retrospective study A Baseline WBMRI scans in metastatic APC patients acquired up to 8 weeks prior to the initiation of a new line of therapy.
- Retrospective study B Paired WBMRI scans in metastatic APC patients at baseline within 8 weeks prior to treatment and at 12 ± 3 weeks after systemic treatment
- Prospective study C Written informed consent. Age ≥18 years. Advanced prostate cancer patients with indication for systemic anti-cancer therapy to be enrolled in a clinical study.
- Participants must have a baseline WBMRI and CT-guided bone marrow biopsy.
Who cannot join
- Prospective Study C Patient is claustrophobic. Contraindications to MRI examination (e.g., cardiac pacemakers, cochlear implants).
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
The Royal Marsden NHS Foundation Trust
Sutton, Surrey, SM2 5PT
Ana Ribeiro, 02089156499, ana.ribeiro@rmh.nhs.uk
Tiaan Jacobs, tiaan.jacobs@rmh.nhs.uk
About this study
Official title: Improving Diagnosis and Treatment of Metastatic Advanced Prostate Cancer Through Better Imaging With Whole-Body Magnetic Resonance Imaging With Diffusion Weighted Imaging
The aim of this study is to provide clinical evidence to determine if Whole Body Magnetic Resonance Imaging (WBMRI) with a novel technique called diffusion-weighted imaging (DWI) can improve current treatment for APC patients, allowing for early identification of disease progression or treatment response, hence facilitating clinical decision-making and leading to improvement in patient care. The IDT study includes two retrospective analyses and a single centre prospective observational study for APC patients.
Read the detailed description
Metastatic Advanced Prostate Cancer occurs when cancer spreads from the prostate to other parts of the body (bones, lymph nodes or other organs), with bones being the commonest site of spread in prostate cancer. These cancer growths are called metastases. APC metastases are diverse (heterogeneous) in their growth pattern, such that not all metastases will respond to the same treatment.
- Conditions
- Advanced Prostate Carcinoma
- Being tested
- Post-treatment CT-guided bone marrow biopsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Post-treatment CT-guided bone marrow biopsyDiagnostic test
At post-treatment, 12 +/- 3 weeks after initiating treatment, patients will undergo a CT guided bone marrow biopsy of the same lesion as baseline.
What is being measured
The primary outcome is the main question the study is designed to answer.
Retrospective analysis: WBMRI parameters
Prognostic association of derived pre-treatment WBMRI parameters, total disease volume (tDV) and apparent diffusion coefficient (ADC) for prediction of overall survival.
Measured: Month 1-26
Retrospective analysis: Diagnostic performance of MET-RADS-P
Accuracy of MET-RADS-P to assess response to systemic treatment.
Measured: Month 1-26
Single centre prospective observational imaging study
Pairwise correlations of percentage of ADC change with:
- Tumour regression grading according to the international system of Salzer-Kuntschnik
- Changes in biopsy tumour content and tumour/necrosis ratio
- Fat fraction percentage with bone marrow adipose tissue/fibrosis reported by histopathology analysis.
Measured: Month 6-38
Secondary outcomes (3)
Retrospective analysis: WBMRI parameters
Prognostic association of baseline tDV and ADC for prediction of radiographic Progression Free Survival (rPFS) using Prostate Cancer Working Group 3 criteria (PCWG3) and Skeletal Related Events (SREs).
Measured: Month 1-26
Retrospective analysis: Diagnostic performance of MET-RADS-P
Inter-observer agreement - determine prognostic association of MET-RADS-P response for prediction of overall survival.
Measured: Month 1-26
Single centre prospective observational imaging study
Fraction of bone biopsies with sufficient tumour yield for genomic sequencing.
Measured: Month 6-38
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2021
- Study start30 Jul 2021 (estimated)
- Primary completion31 May 2024 (estimated)
- Study completion31 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Prostate CarcinomaStudies 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
- Responsible party
- Sponsor
- Investigators
- Nina Tunariu, Principal investigator, The Royal Marsden NHS FT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04984395
- Sponsor's protocol ID
- CCR5459
- Acronym
- IDT
- Status last verified
- May 2021
- First submitted
- 21 Jul 2021
- Last updated
- 30 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The main study results will be published in a peer-reviewed journal, on behalf of all collaborators. The manuscript will be prepared by a writing group, consisting of members of the Study Management Group.
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Diagnosis and Treatment of Metastatic Advanced Prostate Cancer Through Better Imaging With Whole-Body Magnetic Resonance Imaging With Diffusion Weighted Imaging
- ClinicalTrials.gov ID
- NCT04984395
- Acronym / sponsor ID
- IDT / CCR5459
- Conditions
- Advanced Prostate Carcinoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Royal Marsden NHS Foundation TrustUniversity, hospital or other
- Study start
- 30 Jul 2021 (estimated)
- Primary completion
- 31 May 2024 (estimated)
- Study completion
- 31 May 2024 (estimated)
- First posted
- 30 Jul 2021 (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.
The aim of this study is to provide clinical evidence to determine if Whole Body Magnetic Resonance Imaging (WBMRI) with a novel technique called diffusion-weighted imaging (DWI) can improve current treatment for APC patients, allowing for early identification of disease progression or treatment response, hence facilitating clinical decision-making and leading to improvement in patient care. The IDT study includes two retrospective analyses and a single centre prospective observational study for APC patients.
Detailed description
Metastatic Advanced Prostate Cancer occurs when cancer spreads from the prostate to other parts of the body (bones, lymph nodes or other organs), with bones being the commonest site of spread in prostate cancer. These cancer growths are called metastases. APC metastases are diverse (heterogeneous) in their growth pattern, such that not all metastases will respond to the same treatment.
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
- Patients with metastatic, advanced prostate cancer.
Key inclusion criteria (4 listed)
- Retrospective study A Baseline WBMRI scans in metastatic APC patients acquired up to 8 weeks prior to the initiation of a new line of therapy.
- Retrospective study B Paired WBMRI scans in metastatic APC patients at baseline within 8 weeks prior to treatment and at 12 ± 3 weeks after systemic treatment
- Prospective study C Written informed consent. Age ≥18 years. Advanced prostate cancer patients with indication for systemic anti-cancer therapy to be enrolled in a clinical study.
- Participants must have a baseline WBMRI and CT-guided bone marrow biopsy.
Key exclusion criteria (1 listed)
- Prospective Study C Patient is claustrophobic. Contraindications to MRI examination (e.g., cardiac pacemakers, cochlear implants).
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 |
|---|---|---|
| Post-treatment CT-guided bone marrow biopsyAt post-treatment, 12 +/- 3 weeks after initiating treatment, patients will undergo a CT guided bone marrow biopsy of the same lesion as baseline. | Diagnostic test | – |
Primary outcome
Retrospective analysis: WBMRI parameters
Time frame: Month 1-26
Prognostic association of derived pre-treatment WBMRI parameters, total disease volume (tDV) and apparent diffusion coefficient (ADC) for prediction of overall survival.
Retrospective analysis: Diagnostic performance of MET-RADS-P
Time frame: Month 1-26
Accuracy of MET-RADS-P to assess response to systemic treatment.
Single centre prospective observational imaging study
Time frame: Month 6-38
Pairwise correlations of percentage of ADC change with: 1. Tumour regression grading according to the international system of Salzer-Kuntschnik 2. Changes in biopsy tumour content and tumour/necrosis ratio 3. Fat fraction percentage with bone marrow adipose tissue/fibrosis reported by histopathology analysis.
3 secondary outcomes
Retrospective analysis: WBMRI parameters
Time frame: Month 1-26
Retrospective analysis: Diagnostic performance of MET-RADS-P
Time frame: Month 1-26
Single centre prospective observational imaging study
Time frame: Month 6-38
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2021.
- Individual participant dataSharing planned: Yes. The main study results will be published in a peer-reviewed journal, on behalf of all collaborators. The manuscript will be prepared by a writing group, consisting of members of the Study Management Group.
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Prostate Cancer
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.
Nina Tunariu principal investigator
The Royal Marsden NHS FT
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 Carcinoma, 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 1 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 30 Jul 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?
Contact Ana Ribeiro (02089156499, ana.ribeiro@rmh.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retrospective analysis: WBMRI parameters (time frame: Month 1-26). The study lists 3 primary outcomes in all. 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 30 Jul 2021.