Localising Occult Prostate Cancer Metastases With Advanced Imaging TEchniques (LOCATE)

Whole Body Multi---Parametric MRI: Accuracy in Staging of Biochemically Relapsed Prostate Cancer

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.

Study Overview

• Status: Unknown
• Conditions: Prostate Cancer
• Intervention / Treatment: Radiation: Whole body MRI

Detailed Description

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.

• Study Type: Observational
• Enrollment (Anticipated): 130

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, NW1 2PG
    • Recruiting
    • Centre for Medical Imaging
    • Principal Investigator: Shonit Punwani

Participation Criteria

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

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

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	The investigator will evaluate using blood test, differences between Human Epidermal growth factor Receptor analysis in patients with castrate-resistant metastatic prostate cancer and non-metastatic patient to explore any significant 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

Collaborators and Investigators

• Sponsor: University College, London
• Investigators: Principal Investigator: Shonit Punwani, Centre for Medical Imaging

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Anticipated): January 1, 2018
• Study Completion (Anticipated): January 1, 2018

Study Registration Dates

• First Submitted: December 1, 2015
• First Submitted That Met QC Criteria: October 13, 2016
• First Posted (Estimate): October 18, 2016

Study Record Updates

• Last Update Posted (Estimate): October 18, 2016
• Last Update Submitted That Met QC Criteria: October 13, 2016
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: 15/0047

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES