Localising Occult Prostate Cancer Metastases With Advanced Imaging TEchniques

Prostate Cancer Clinical Trial

— LOCATE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02935816
• Other study ID #: 15/0047
• Status: Recruiting
• Phase: N/A
• First received: December 1, 2015
• Last updated: October 13, 2016
• Start date: January 2015
• Est. completion date: January 2018

Study information

• Verified date: December 2015
• Source: University College, London
• Contact: Joey J Clemente
• Phone: 02034479094
• Email: joey.clemente[@]uclh.nhs.uk
• Is FDA regulated: No
• Health authority: United Kingdom: National Institute for Social Care and Health ResearchUnited Kingdom: Research Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 130
• Est. completion date: January 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Radiation:
• 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

Locations

Country	Name	City	State
United Kingdom	Centre for Medical Imaging	London

Sponsors (1)

Lead Sponsor	Collaborator
University College, London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	The investigator will investigate whether there would be any significant correlation between MRI quantitative parameters and the response following treatment.		3 years	No
Secondary	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	No
Secondary	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	No
Secondary	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	No