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Cancer Diagnosis by Multiparametric UltraSound of the Prostate (CADMUS)

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ClinicalTrials.gov Identifier: NCT02712684
Recruitment Status : Unknown
Verified August 2016 by University College, London.
Recruitment status was:  Recruiting
First Posted : March 18, 2016
Last Update Posted : August 9, 2016
Sponsor:
Information provided by (Responsible Party):
University College, London

Brief Summary:
In men who require a prostate biopsy does a multi-parametric ultrasound based diagnostic strategy compared to a multi-parametric MRI based diagnostic strategy lead to similar detection of clinically significant prostate cancer?

Condition or disease Intervention/treatment
Prostate Cancer Procedure: multiparametric MRI. Multi-parametric ultrasound

Detailed Description:
Men who require prostate biopsy will be approached and consented to enter this study. Participants will all undergo pre-biopsy mp-MRI and mp-USS of the prostate. Only men with positive scans will undergo prostate biopsy. The order in which lesions discovered on mp-MRI or on mp-USS are sampled will be randomised. All biopsies will be taken via the transperineal route in a single procedure. Comparison will be drawn between biopsy results of lesions detected by mp-USS with those lesions detected by mp-MRI. Consideration will be given as to whether a lesion detected by one imaging modality is the same abnormality as one detected by the other imaging modality, in the same patient. Analysis will be carried out at both the level of the lesion and the whole prostate. Men without suspicious lesions on either imaging modality will not proceed to biopsy.

Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Multi-parametric Ultrasound Targeted Biopsies Compared to Multi-parametric MRI Targeted Biopsies in the Diagnosis of Clinically Significant Prostate Cancer
Study Start Date : July 2015
Estimated Primary Completion Date : May 2017
Estimated Study Completion Date : July 2017

Resource links provided by the National Library of Medicine



Intervention Details:
  • Procedure: multiparametric MRI. Multi-parametric ultrasound
    The investigators aim to test the hypothesis that multiparametric ultrasound is able to detect clinically significant prostate cancer with an accuracy that is similar to multiparametric MRI. Multi-parametric ultrasound uses different types of ultrasound images to visualise different aspects of the tissue. In other words, the standard grey-scale images shows the gross anatomy, Power Doppler and Contrast enhanced Ultrasound image blood supply (cancers have more blood supply), and Real-Time Elastography images the density of tissue (cancers are more dense).


Primary Outcome Measures :
  1. To determine the overall agreement in identifying lesions to biopsy between mp-USS and mp-MRI in men who require a prostate biopsy. Then compare agreement in proportion of men diagnosed with clinically significant prostate cancer on biopsy. [ Time Frame: at time of surgery ]
    Clinically significant for the purpose will be defined by UCL/Ahmed definition 1:Gleason ≥4+3 and/or maximum cancer core length of ≥ 6mm


Secondary Outcome Measures :
  1. To compare the overall agreement in proportion of men diagnosed with other thresholds of clinically significant prostate cancer on biopsy [ Time Frame: at time of surgery ]
    Thresholds for clinical significance namely UCL/Ahmed definition 2 (a) Gleason ≥ 3+4 and/or Maximum cancer core length ≥ 4mm, (b) Gleason ≥ 3+4 and or MCCL ≥ 6mm (c) Any length of Gleason ≥ 3+4 (d) Any length of Gleason ≥4+3

  2. To determine the detection of clinically significant cancer (using all of the pre-specified definitions based on histology) by using the combination of these two imaging techniques versus either modality alone [ Time Frame: at time of surgery ]
  3. To determine whether the order in which the targeted biopsies are carried out, either to the same target (present on both scans) or different targets impacts on detection of clinically significant cancer [ Time Frame: at time of surgery ]
    clinically significant cancer (using all of the pre-specified definitions based on histology)

  4. To compare, in those men who go on to radical prostatectomy, the mp-MRI, mp-USS and histology from targeted biopsy with the whole mount specimen obtained at surgery. [ Time Frame: at time of surgery ]
  5. To create an inception cohort of men, consented for long-term follow-up and linkage, providing the potential for further translational and clinical studies [ Time Frame: at time of surgery ]
  6. To determine rates of adverse events, resource utilization and impact of each test on health-related quality-of-life (using EQ-5D-5L questionnaire) which would allow modelling of overall cost-effectiveness of one strategy compared to the other. [ Time Frame: at time of surgery ]


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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:   Probability Sample
Study Population
Men at or referred to the participating centres who may require a prostate biopsy. Referrals will be screened and potential participants contacted by telephone, post or email. These men will be given the patient information sheet at least 24 hours before their clinic visit, allowing adequate time to consider their desire for involvement
Criteria

Inclusion Criteria:

  1. A potential need for prostate biopsy indicated by raised PSA or other clinical parameter, the final decision over which will be taken after imaging.
  2. PSA </=20ng/ml measured within 6 months of screening visit
  3. An understanding of the English language sufficient to understand written and verbal information about the trial and consent process
  4. Estimated life expectancy of 5 years or more
  5. Signed informed consent

Exclusion Criteria:

  1. Any contraindication to the ultrasound contrast agent including right to left shunt, pulmonary hypertension, uncontrolled hypertension and adult respiratory distress syndrome. Also patients with a recent acute coronary syndrome or unstable ischaemic heart disease.
  2. Any form of hormones (except 5-alpha reductase inhibitors) within 6 months of screening visit
  3. Irreversible coagulopathy predisposing to bleeding
  4. Inability to undergo transrectal ultrasonography
  5. Prostate volume, measured at the time of mp-USS if previously unknown, of >60cc.
  6. Previous radiation therapy to the prostate
  7. Previous HIFU, cryosurgery, thermal therapy, irreversible electroporation, photodynamic, photothermal therapy, microwave or injectable toxin therapy to the prostate.
  8. Transurethral resection or vaporization of the prostate for benign prostatic hyperplasia using any energy modality within 6 months of screening visit
  9. Nodal or metastatic prostate cancer on any form of imaging at any time-point
  10. Not fit for general anaesthetic
  11. Any other condition the investigator considers would make the patient unsuitable

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): NCT02712684


Contacts
Contact: Bina Shah +44 (0)20 7679 9280 SITU.CADMUS@ucl.ac.uk

Locations
United Kingdom
University College London Hospitals Recruiting
London,, England, United Kingdom, WIT 3AA
Contact: Bina Shah    +44 (0)20 7679 9280    SITU.CADMUS@ucl.ac.uk   
Principal Investigator: Hashim U Ahmed, MD         
Sub-Investigator: Alistair Grey         
Sponsors and Collaborators
University College, London

Publications of Results:
Responsible Party: University College, London
ClinicalTrials.gov Identifier: NCT02712684     History of Changes
Other Study ID Numbers: 15/0473
First Posted: March 18, 2016    Key Record Dates
Last Update Posted: August 9, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases