Improving Diagnosis and Treatment of Metastatic Advanced Prostate Cancer (IDT)

July 21, 2021 updated by: Royal Marsden NHS Foundation Trust

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United Kingdom
    • Surrey
      • Sutton, Surrey, United Kingdom, SM2 5PT
        • The Royal Marsden NHS Foundation Trust
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Dow-Mu Koh, Professor
        • Principal Investigator:
          • Nina Tunariu, Consultant
        • Sub-Investigator:
          • Johann DeBono, Professor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

Patients with metastatic, advanced prostate cancer.

Description

Inclusion Criteria:

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.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Month 1-26
Retrospective analysis: Diagnostic performance of MET-RADS-P
Time Frame: Month 1-26
Accuracy of MET-RADS-P to assess response to systemic treatment.
Month 1-26
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.
Month 6-38

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Retrospective analysis: WBMRI parameters
Time Frame: Month 1-26
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).
Month 1-26
Retrospective analysis: Diagnostic performance of MET-RADS-P
Time Frame: Month 1-26
Inter-observer agreement - determine prognostic association of MET-RADS-P response for prediction of overall survival.
Month 1-26
Single centre prospective observational imaging study
Time Frame: Month 6-38
Fraction of bone biopsies with sufficient tumour yield for genomic sequencing.
Month 6-38

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Royal Marsden NHS Foundation Trust

Investigators

  • Principal Investigator: Nina Tunariu, The Royal Marsden NHS FT

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

July 30, 2021

Primary Completion (Anticipated)

May 31, 2024

Study Completion (Anticipated)

May 31, 2024

Study Registration Dates

First Submitted

July 21, 2021

First Submitted That Met QC Criteria

July 21, 2021

First Posted (Actual)

July 30, 2021

Study Record Updates

Last Update Posted (Actual)

July 30, 2021

Last Update Submitted That Met QC Criteria

July 21, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCR5459

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

Fully anonymised trial data will be made available.

IPD Sharing Access Criteria

Data Sharing / Transfer Agreements to be in place.

IPD Sharing Supporting Information Type

  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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