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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2015

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2017

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 4, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 14, 2016

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 18, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 9, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 8, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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