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

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ClinicalTrials.gov Identifier: NCT02935816
Recruitment Status : Unknown
Verified December 2015 by University College, London.
Recruitment status was:  Recruiting
First Posted : October 18, 2016
Last Update Posted : October 18, 2016
Sponsor:
Information provided by (Responsible Party):
University College, London

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.

Condition or disease Intervention/treatment
Prostate Cancer 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.

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Study Type : Observational
Estimated Enrollment : 130 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Whole Body Multi--‐Parametric MRI: Accuracy in Staging of Biochemically Relapsed Prostate Cancer
Study Start Date : January 2015
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : January 2018

Resource links provided by the National Library of Medicine



Intervention Details:
  • 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


Primary Outcome Measures :
  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 [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. 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. [ Time Frame: 3 years ]
  2. The investigator will investigate whether there would be any significant correlation between MRI quantitative parameters and the response following treatment. [ Time Frame: 3 years ]
  3. The investigator will evaluate using blood test differences between two groups [ Time Frame: 3 years ]
    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

  4. The investigator will asses the Cost-effectiveness by comparing the direct and indirect costs of multi-modality imaging path versus WB-MRI path [ Time Frame: 3 years ]
  5. 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 [ Time Frame: 3 years ]

Biospecimen Retention:   Samples With DNA
100 ml of blood sample for exosome analysis


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Prostaete cancer patients with biochemical relapse following external beam radiotherapy or brachytherapy of locally advanced prostate cancer.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02935816


Contacts
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Contact: Joey J Clemente 02034479094 ext 79094 joey.clemente@uclh.nhs.uk

Locations
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United Kingdom
Centre for Medical Imaging Recruiting
London, United Kingdom, NW1 2PG
Contact: Joey J Clemente    02034479094 ext 79094    joey.clemente@uclh.nhs.uk   
Principal Investigator: Shonit Punwani         
Sponsors and Collaborators
University College, London
Investigators
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Principal Investigator: Shonit Punwani Centre for Medical Imaging

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Responsible Party: University College, London
ClinicalTrials.gov Identifier: NCT02935816     History of Changes
Other Study ID Numbers: 15/0047
First Posted: October 18, 2016    Key Record Dates
Last Update Posted: October 18, 2016
Last Verified: December 2015
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases