NCT04984395

Brief 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 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 21, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 30, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

July 30, 2021

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2024

Completed
Last Updated

July 30, 2021

Status Verified

May 1, 2021

Enrollment Period

2.8 years

First QC Date

July 21, 2021

Last Update Submit

July 21, 2021

Conditions

Advanced Prostate Carcinoma

Outcome Measures

Primary Outcomes (3)

  • 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.

    Month 1-26

  • Retrospective analysis: Diagnostic performance of MET-RADS-P

    Accuracy of MET-RADS-P to assess response to systemic treatment.

    Month 1-26

  • Single centre prospective observational imaging study

    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.

    Month 6-38

Secondary Outcomes (3)

  • Retrospective analysis: WBMRI parameters

    Month 1-26

  • Retrospective analysis: Diagnostic performance of MET-RADS-P

    Month 1-26

  • Single centre prospective observational imaging study

    Month 6-38

Interventions

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.

Eligibility Criteria

Age18 Years+
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsMale with prostate cancer.
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with metastatic, advanced prostate cancer.

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Royal Marsden NHS Foundation Trust

Sutton, Surrey, SM2 5PT, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

Bone marrow biopsy.

Study Officials

  • Nina Tunariu

    The Royal Marsden NHS FT

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ana Ribeiro

CONTACT

02089156499ana.ribeiro@rmh.nhs.uk

Tiaan Jacobs

CONTACT

02089156499tiaan.jacobs@rmh.nhs.uk

Study Design

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

Study Record Dates

First Submitted

July 21, 2021

First Posted

July 30, 2021

Study Start

July 30, 2021

Primary Completion

May 31, 2024

Study Completion

May 31, 2024

Last Updated

July 30, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
CSR
Time Frame
Fully anonymised trial data will be made available.
Access Criteria
Data Sharing / Transfer Agreements to be in place.

Locations

GB(1)