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Improving Diagnosis and Treatment of Metastatic Advanced Prostate Cancer

NCT ID: NCT04984395

Last Updated: 2021-07-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-07-30

Study Completion Date

2024-05-31

Brief Summary

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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

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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

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Advanced Prostate Carcinoma

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Royal Marsden NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nina Tunariu

Role: PRINCIPAL_INVESTIGATOR

The Royal Marsden NHS FT

Locations

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The Royal Marsden NHS Foundation Trust

Sutton, Surrey, United Kingdom

Site Status

Countries

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United Kingdom

Central Contacts

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Ana Ribeiro

Role: CONTACT

Phone: 02089156499

Email: [email protected]

Tiaan Jacobs

Role: CONTACT

Phone: 02089156499

Email: [email protected]

Facility Contacts

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Ana Ribeiro

Role: primary

Tiaan Jacobs

Role: backup

Other Identifiers

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CCR5459

Identifier Type: -

Identifier Source: org_study_id