Prostate CancerCADMUSNCT02712684
Cancer Diagnosis by Multiparametric UltraSound of the Prostate
An observational study of Prostate Cancer, run by University College, London at 1 site in United Kingdom.
Trial 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? Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- multiparametric MRI. Multi-parametric ultrasound
- Type of treatment
- Surgery or procedure
- How many people
- 500 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2015to Jul 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- A potential need for prostate biopsy indicated by raised PSA or other clinical parameter, the final decision over which will be taken after imaging.
- PSA </=20ng/ml measured within 6 months of screening visit
- An understanding of the English language sufficient to understand written and verbal information about the trial and consent process
- Estimated life expectancy of 5 years or more
- Signed informed consent
Who cannot join
- 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.
- Any form of hormones (except 5-alpha reductase inhibitors) within 6 months of screening visit
- Irreversible coagulopathy predisposing to bleeding
- Inability to undergo transrectal ultrasonography
- Prostate volume, measured at the time of mp-USS if previously unknown, of >60cc.
- Previous radiation therapy to the prostate
Show all 11Show fewer
- Previous HIFU, cryosurgery, thermal therapy, irreversible electroporation, photodynamic, photothermal therapy, microwave or injectable toxin therapy to the prostate.
- Transurethral resection or vaporization of the prostate for benign prostatic hyperplasia using any energy modality within 6 months of screening visit
- Nodal or metastatic prostate cancer on any form of imaging at any time-point
- Not fit for general anaesthetic
- Any other condition the investigator considers would make the patient unsuitable
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
University College London Hospitals
London, England, WIT 3AA
Bina Shah, +44 (0)20 7679 9280, SITU.CADMUS@ucl.ac.uk
Hashim U Ahmed, MD
About this study
Official title: 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?
Read the 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.
- Conditions
- Prostate Cancer
- Being tested
- multiparametric MRI. Multi-parametric ultrasound
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
multiparametric MRI. Multi-parametric ultrasoundProcedure or surgery
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).
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Clinically significant for the purpose will be defined by UCL/Ahmed definition 1:Gleason ≥4+3 and/or maximum cancer core length of ≥ 6mm
Measured: at time of surgery
Secondary outcomes (6)
To compare the overall agreement in proportion of men diagnosed with other thresholds of clinically significant prostate cancer on biopsy
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
Measured: 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
Measured: 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
clinically significant cancer (using all of the pre-specified definitions based on histology)
Measured: 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.
Measured: 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
Measured: 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.
Measured: at time of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2016 (estimated)
- Study startJul 2015
- Primary completionMay 2017 (estimated)
- Study completionJul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02712684
- Sponsor's protocol ID
- 15/0473
- Acronym
- CADMUS
- Status last verified
- Aug 2016
- First submitted
- 4 Feb 2016
- Last updated
- 9 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Velonas VM, Woo HH, dos Remedios CG, Assinder SJ. Current status of biomarkers for prostate cancer. Int J Mol Sci. 2013 May 24;14(6):11034-60. doi: 10.3390/ijms140611034.
PubMed 23708103Kirkham AP, Haslam P, Keanie JY, McCafferty I, Padhani AR, Punwani S, Richenberg J, Rottenberg G, Sohaib A, Thompson P, Turnbull LW, Kurban L, Sahdev A, Clements R, Carey BM, Allen C. Prostate MRI: who, when, and how? Report from a UK consensus meeting. Clin Radiol. 2013 Oct;68(10):1016-23. doi: 10.1016/j.crad.2013.03.030. Epub 2013 Jul 1.
PubMed 23827086Welch HG, Albertsen PC. Prostate cancer diagnosis and treatment after the introduction of prostate-specific antigen screening: 1986-2005. J Natl Cancer Inst. 2009 Oct 7;101(19):1325-9. doi: 10.1093/jnci/djp278. Epub 2009 Aug 31.
PubMed 19720969Wilt TJ, Ahmed HU. Prostate cancer screening and the management of clinically localized disease. BMJ. 2013 Jan 29;346:f325. doi: 10.1136/bmj.f325. No abstract available.
PubMed 23360718Wei JT. Limitations of a contemporary prostate biopsy: the blind march forward. Urol Oncol. 2010 Sep-Oct;28(5):546-9. doi: 10.1016/j.urolonc.2009.12.022.
PubMed 20816614Thompson IM, Ankerst DP, Tangen CM. Prostate-specific antigen, risk factors, and prostate cancer: confounders nestled in an enigma. J Natl Cancer Inst. 2010 Sep 8;102(17):1299-301. doi: 10.1093/jnci/djq313. Epub 2010 Aug 19. No abstract available.
PubMed 20724727Grey ADR, Scott R, Shah B, Acher P, Liyanage S, Pavlou M, Omar R, Chinegwundoh F, Patki P, Shah TT, Hamid S, Ghei M, Gilbert K, Campbell D, Brew-Graves C, Arumainayagam N, Chapman A, McLeavy L, Karatziou A, Alsaadi Z, Collins T, Freeman A, Eldred-Evans D, Bertoncelli-Tanaka M, Tam H, Ramachandran N, Madaan S, Winkler M, Arya M, Emberton M, Ahmed HU. Multiparametric ultrasound versus multiparametric MRI to diagnose prostate cancer (CADMUS): a prospective, multicentre, paired-cohort, confirmatory study. Lancet Oncol. 2022 Mar;23(3):428-438. doi: 10.1016/S1470-2045(22)00016-X.
PubMed 35240084
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-parametric Ultrasound Targeted Biopsies Compared to Multi-parametric MRI Targeted Biopsies in the Diagnosis of Clinically Significant Prostate Cancer
- ClinicalTrials.gov ID
- NCT02712684
- Acronym / sponsor ID
- CADMUS / 15/0473
- Conditions
- Prostate Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- May 2017 (estimated)
- Study completion
- Jul 2017 (estimated)
- First posted
- 18 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (5 listed)
- A potential need for prostate biopsy indicated by raised PSA or other clinical parameter, the final decision over which will be taken after imaging.
- PSA </=20ng/ml measured within 6 months of screening visit
- An understanding of the English language sufficient to understand written and verbal information about the trial and consent process
- Estimated life expectancy of 5 years or more
- Signed informed consent
Key exclusion criteria (11 listed)
- 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.
- Any form of hormones (except 5-alpha reductase inhibitors) within 6 months of screening visit
- Irreversible coagulopathy predisposing to bleeding
- Inability to undergo transrectal ultrasonography
- Prostate volume, measured at the time of mp-USS if previously unknown, of >60cc.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| multiparametric MRI. Multi-parametric ultrasoundThe 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). | Procedure or surgery | – |
Primary outcome
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
6 secondary outcomes
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
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
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
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2016.
- Results publication: PubMed 23708103Velonas VM, Woo HH, dos Remedios CG, Assinder SJ. Current status of biomarkers for prostate cancer. Int J Mol Sci. 2013 May 24;14(6):11034-60. doi: 10.3390/ijms140611034.
- Results publication: PubMed 23827086Kirkham AP, Haslam P, Keanie JY, McCafferty I, Padhani AR, Punwani S, Richenberg J, Rottenberg G, Sohaib A, Thompson P, Turnbull LW, Kurban L, Sahdev A, Clements R, Carey BM, Allen C. Prostate MRI: who, when, and how? Report from a UK consensus meeting. Clin Radiol. 2013 Oct;68(10):1016-23. doi: 10.1016/j.crad.2013.03.030. Epub 2013 Jul 1.
- Results publication: PubMed 19720969Welch HG, Albertsen PC. Prostate cancer diagnosis and treatment after the introduction of prostate-specific antigen screening: 1986-2005. J Natl Cancer Inst. 2009 Oct 7;101(19):1325-9. doi: 10.1093/jnci/djp278. Epub 2009 Aug 31.
- Results publication: PubMed 23360718Wilt TJ, Ahmed HU. Prostate cancer screening and the management of clinically localized disease. BMJ. 2013 Jan 29;346:f325. doi: 10.1136/bmj.f325. No abstract available.
- Results publication: PubMed 20816614Wei JT. Limitations of a contemporary prostate biopsy: the blind march forward. Urol Oncol. 2010 Sep-Oct;28(5):546-9. doi: 10.1016/j.urolonc.2009.12.022.
- Results publication: PubMed 20724727Thompson IM, Ankerst DP, Tangen CM. Prostate-specific antigen, risk factors, and prostate cancer: confounders nestled in an enigma. J Natl Cancer Inst. 2010 Sep 8;102(17):1299-301. doi: 10.1093/jnci/djq313. Epub 2010 Aug 19. No abstract available.
- Derived from this study: PubMed 35240084Grey ADR, Scott R, Shah B, Acher P, Liyanage S, Pavlou M, Omar R, Chinegwundoh F, Patki P, Shah TT, Hamid S, Ghei M, Gilbert K, Campbell D, Brew-Graves C, Arumainayagam N, Chapman A, McLeavy L, Karatziou A, Alsaadi Z, Collins T, Freeman A, Eldred-Evans D, Bertoncelli-Tanaka M, Tam H, Ramachandran N, Madaan S, Winkler M, Arya M, Emberton M, Ahmed HU. Multiparametric ultrasound versus multiparametric MRI to diagnose prostate cancer (CADMUS): a prospective, multicentre, paired-cohort, confirmatory study. Lancet Oncol. 2022 Mar;23(3):428-438. doi: 10.1016/S1470-2045(22)00016-X.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by University College, London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bina Shah (+44 (0)20 7679 9280, SITU.CADMUS@ucl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02712684, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2016.