Localising Occult Prostate Cancer Metastases With Advanced Imaging TEchniques

NCT02935816 | Unknown

• 1 other identifier: 15/0047
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• The investigator will measure and analyse sensitivity and specificity of WB-MRI compared to conventional multi-modality imaging for detection of regional lymph node distant metastasis.T

  3 years

Secondary Outcomes (5)

• Interobserver agreement for WB-MRI: Per-site and per-nodal staging assessment will be done by two radiologists separately and then in consensus. Kappa agreement statistic will be tested for the level of agreement for per-site and per-patient assessments.

  3 years

• The investigator will investigate whether there would be any significant correlation between MRI quantitative parameters and the response following treatment.

  3 years

• The investigator will evaluate using blood test differences between two groups

  3 years

• The investigator will asses the Cost-effectiveness by comparing the direct and indirect costs of multi-modality imaging path versus WB-MRI path

  3 years

• The investagator will measure sensitivity and specificity of WB-MRI compared to choline PET-CT for detection of regional lymph node distant metastasis. Analysis of sensitivity and specificity will be investigated on per-site basis and per-patient basis

  3 years

Interventions

Whole body MRI RADIATION

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

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Prostaete cancer patients with biochemical relapse following external beam radiotherapy or brachytherapy of locally advanced prostate cancer.

You may qualify if:

• 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)

You may not qualify if:

• Men unable to have MRI scan, or in whom artefact would significantly reduce quality of MRI
• Men unable to give informed consent

Sponsors & Collaborators

• University College, London: lead

Study Sites (1)

Centre for Medical Imaging

London, NW1 2PG, United Kingdom

RECRUITING

Related Publications (1)

• 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.

  PMID: 31730466 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

100 ml of blood sample for exosome analysis

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Shonit Punwani

  Centre for Medical Imaging

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joey J Clemente

CONTACT

02034479094; joey.clemente@uclh.nhs.uk

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2015
• First Posted: October 18, 2016
• Study Start: January 1, 2015
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2018
• Last Updated: October 18, 2016

Record last verified: 2015-12

Data Sharing

• IPD Sharing: Will share

Locations

GB (1)