Whole Body Magnetic Resonance Imaging Study

NCT04117594 | Unknown

• 1 other identifier: CCR 5035
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Advanced Prostate Cancer

Keywords

Prostate cancer; WB-MRI; Bone disease

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  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

  6 months

• Intra-observer and inter-observer agreement of ADC and TDV

  1 year

• Assess the cost-effectiveness of replacing CT and BS with WB-MRI derived measurements TDV and ADC

  1 year

Other Outcomes (4)

• Histogram parameters of ADC

  6 months

• Histogram parameters of TDV

  6 months

• Histogram parameters of fat fractions

  6 months

Interventions

WB-MRI DIAGNOSTIC_TEST

Whole body MRI with diffusion-weighted imaging (DWI)

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Male patients with advanced prostate cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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).

You may qualify if:

• Written informed consent
• Age ≥18 years
• Systemic therapy indicated for disease progression, as clinically indicated.

You may not qualify if:

• Patient is claustrophobic.
• Contraindications to MRI examination (e.g. cardiac pacemakers, cochlear implants).

Sponsors & Collaborators

• Royal Marsden NHS Foundation Trust: lead
• National Institute for Health Research, United Kingdom: collaborator
• Institute of Cancer Research, United Kingdom: collaborator

Study Sites (1)

The Royal Marsden NHS Foundation Trust

Sutton, Surrey, SM2 5PT, United Kingdom

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Bone Diseases

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Musculoskeletal Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2019
• First Posted: October 7, 2019
• Study Start: October 9, 2019
• Primary Completion: June 1, 2021
• Study Completion: June 1, 2021
• Last Updated: May 19, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: Data will be available within 1 year of study completion.

Locations

GB (1)