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

University College London (UCL)

Status: Unknown

Conditions: Prostate Cancer

Treatments: Radiation: Whole body MRI

Study type: Observational

Funder types: Other

Identifiers

NCT02935816

15/0047

Details and patient eligibility

About

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.

Full 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.

Enrollment: 130 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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