Localising Occult Prostate Cancer Metastases With Advanced Imaging TEchniques

NCT ID: NCT02935816

Last Updated: 2016-10-18

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

130 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-01-31

Study Completion Date

2018-01-31

Brief Summary

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The investigator prospectively compare diagnostic concordance of whole body multi---parametric Magnetic Resonance Imaging (MRI) with current conventional multi---modality reference standard imaging (CT scan, isotope bone scan +/--- PET---CT scan) for staging of prostate cancer patients with biochemical relapse following external beam radiotherapy or brachytherapy of locally advanced prostate cancer.

Detailed Description

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The investigators have developed and assessed the feasibility of performing whole---body multi---parametric MRI for staging metastatic disease. The investigators hypothesize that a whole body multi---parametric MRI will be more sensitive and specific than conventional imaging staging for detection of metastatic disease in patients with biochemical failure following local therapies. Investigators therefore propose a comparative trial of conventional imaging verses whole---body multi---parametric MRI within this population of men. The investigators would further like to explore whether heterogeneity between metastases of multi---parametric MRI signals can predict men unlikely to respond to ADT. The investigators aim to enhance the main study by exploratory work on exosome, pathway and genomic analysis, the results of which could lead to complimentary imaging / non---imaging biomarker combinations of clinical utility for patient stratification. Finally the investigators will perform a health economic analysis to assess the cost---effectiveness of whole---body multi---parametric MRI for metastatic disease staging compared with conventional staging with computed tomography and bone---scans.

Conditions

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Prostate Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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Whole body MRI

We have developed and assessed the feasibility of performing whole---body multi---parametric MRI for staging metastatic disease. We hypothesize that a whole body multi---parametric MRI will be more sensitive and specific than conventional imaging staging for detection of metastatic disease in patients with biochemical failure following local therapies. We therefore propose a comparative trial of conventional imaging verses whole---body multi---parametric MRI within this population of men

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

* Men who have undergone previous external beam radiotherapy or brachytherapy with or without neo---adjuvant/adjuvant hormone therapy
* Men who have radiorecurrent disease defined by biochemical failure - Phoenix definition (PSA nadir + 2 ng/mL)

Exclusion Criteria

* Men unable to have MRI scan, or in whom artefact would significantly reduce quality of MRI
* Men unable to give informed consent
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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University College, London

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Shonit Punwani

Role: PRINCIPAL_INVESTIGATOR

Centre for Medical Imaging

Locations

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Centre for Medical Imaging

London, , United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Joey J Clemente

Role: CONTACT

02034479094 ext. 79094

Facility Contacts

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Joey J Clemente

Role: primary

02034479094 ext. 79094

References

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Adeleke S, Latifoltojar A, Sidhu H, Galazi M, Shah TT, Clemente J, Davda R, Payne HA, Chouhan MD, Lioumi M, Chua S, Freeman A, Rodriguez-Justo M, Coolen A, Vadgama S, Morris S, Cook GJ, Bomanji J, Arya M, Chowdhury S, Wan S, Haroon A, Ng T, Ahmed HU, Punwani S. Localising occult prostate cancer metastasis with advanced imaging techniques (LOCATE trial): a prospective cohort, observational diagnostic accuracy trial investigating whole-body magnetic resonance imaging in radio-recurrent prostate cancer. BMC Med Imaging. 2019 Nov 15;19(1):90. doi: 10.1186/s12880-019-0380-y.

Reference Type DERIVED
PMID: 31730466 (View on PubMed)

Other Identifiers

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15/0047

Identifier Type: -

Identifier Source: org_study_id

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