Cancer Diagnosis by Multiparametric UltraSound of the Prostate (CADMUS)

August 8, 2016 updated by: University College, London

Multi-parametric Ultrasound Targeted Biopsies Compared to Multi-parametric MRI Targeted Biopsies in the Diagnosis of Clinically Significant Prostate Cancer

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?

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • England
      • London,, England, United Kingdom, WIT 3AA
        • Recruiting
        • University College London Hospitals
        • Contact:
        • Principal Investigator:
          • Hashim U Ahmed, MD
        • Sub-Investigator:
          • Alistair Grey

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
at time of surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
at time of surgery
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
at time of surgery
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)
at time of surgery
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
at time of surgery
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
at time of surgery
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
at time of surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University College, London

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2015

Primary Completion (ANTICIPATED)

May 1, 2017

Study Completion (ANTICIPATED)

July 1, 2017

Study Registration Dates

First Submitted

February 4, 2016

First Submitted That Met QC Criteria

March 14, 2016

First Posted (ESTIMATE)

March 18, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

August 9, 2016

Last Update Submitted That Met QC Criteria

August 8, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15/0473

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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