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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04984395
Recruitment Status : Not yet recruiting
First Posted : July 30, 2021
Last Update Posted : July 30, 2021
Sponsor:
Information provided by (Responsible Party):
Royal Marsden NHS Foundation Trust

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.

Condition or disease Intervention/treatment
Advanced Prostate Carcinoma Diagnostic Test: Post-treatment CT-guided bone marrow biopsy

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.

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Improving Diagnosis and Treatment of Metastatic Advanced Prostate Cancer Through Better Imaging With Whole-Body Magnetic Resonance Imaging With Diffusion Weighted Imaging
Estimated Study Start Date : July 30, 2021
Estimated Primary Completion Date : May 31, 2024
Estimated Study Completion Date : May 31, 2024

Resource links provided by the National Library of Medicine



Intervention Details:
  • Diagnostic Test: Post-treatment CT-guided bone marrow biopsy
    At post-treatment, 12 +/- 3 weeks after initiating treatment, patients will undergo a CT guided bone marrow biopsy of the same lesion as baseline.


Primary Outcome Measures :
  1. 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.

  2. Retrospective analysis: Diagnostic performance of MET-RADS-P [ Time Frame: Month 1-26 ]
    Accuracy of MET-RADS-P to assess response to systemic treatment.

  3. 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.


Secondary Outcome Measures :
  1. 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).

  2. 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.

  3. Single centre prospective observational imaging study [ Time Frame: Month 6-38 ]
    Fraction of bone biopsies with sufficient tumour yield for genomic sequencing.


Biospecimen Retention:   Samples With DNA
Bone marrow biopsy.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Male with prostate cancer.
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with metastatic, advanced prostate cancer.
Criteria

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).


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04984395


Contacts
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Contact: Ana Ribeiro 02089156499 ana.ribeiro@rmh.nhs.uk
Contact: Tiaan Jacobs 02089156499 tiaan.jacobs@rmh.nhs.uk

Locations
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United Kingdom
The Royal Marsden NHS Foundation Trust
Sutton, Surrey, United Kingdom, SM2 5PT
Contact: Ana Ribeiro    02089156499    ana.ribeiro@rmh.nhs.uk   
Contact: Tiaan Jacobs       tiaan.jacobs@rmh.nhs.uk   
Sub-Investigator: Dow-Mu Koh, Professor         
Principal Investigator: Nina Tunariu, Consultant         
Sub-Investigator: Johann DeBono, Professor         
Sponsors and Collaborators
Royal Marsden NHS Foundation Trust
Investigators
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Principal Investigator: Nina Tunariu The Royal Marsden NHS FT
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Responsible Party: Royal Marsden NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT04984395    
Other Study ID Numbers: CCR5459
First Posted: July 30, 2021    Key Record Dates
Last Update Posted: July 30, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Clinical Study Report (CSR)
Time Frame: Fully anonymised trial data will be made available.
Access Criteria: Data Sharing / Transfer Agreements to be in place.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases