Plain English Summary
Trial website
Contact information
Type
Public
Primary contact
Mr Alistair Grey
ORCID ID
Contact details
Room 4.23
132 Hampstead Rd
London
NW1 2PS
United Kingdom
+44 (0)20 7679 9092
cadmus@uclh.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
UCL reference 15/0473
Study information
Scientific title
Multi-parametric ultrasound targeted biopsies compared to multi-parametric MRI targeted biopsies in the diagnosis of clinically significant prostate cancer
Acronym
Study hypothesis
Multiparametric ultrasound has a comparable performance to multiparametric MRI in the detection and risk stratification of prostate lesions that warrant biopsy.
Ethics approval
London (Brent East), 08/10/2015, ref: 15/LO/1331
Study design
Prospective multi-centre cohort diagnostic utility study
Primary study design
Observational
Secondary study design
Cohort study
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Not currently available in web format. The PIS may be requested from CADMUS@uclh.nhs.uk
Condition
Prostate cancer
Intervention
Men who require a prostate biopsy will be approached and consented to enter this study. Participants will all undergo pre-biopsy mp-MRI (reference test) and mp-USS (index test) 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. The first 20 patients recruited will comprise an internal pilot to ensure we are carrying out high quality mp-USS studies.
Intervention type
Device
Phase
Drug names
Primary outcome measure
The proportion of men with a lesion detected using each diagnostic strategy and the proportion of men subsequently diagnosed with clinically significant prostate cancer as defined histologically as UCL/Ahmed definition 1 (Gleason 4+3 or greater and/or maximum cancer core length of 6mm or greater).
Secondary outcome measures
1. The proportion of men diagnosed with clinically significant prostate cancer by each diagnostic strategy as defined histologically using other thresholds for clinical significance, namely:
1.1. UCL/Ahmed definition 2: Gleason >3+4 and/or Maximum cancer core length >4mm
1,2. Gleason >3+4 and/or MCCL >6mm
1.3. Any length of Gleason >3+4
1.4. Any length of Gleason >4+3
2. The proportion of men diagnosed with 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.
3. The proportion of men diagnosed with clinically significant prostate cancer (using all of the pre-specified definitions based on histology) when:
3.1. mp-USS targeted biopsies are carried out first compared to being carried out second and when order in which the targeted biopsies are carried out
3.2. mp-MRI targeted biopsies are carried out first compared to being carried out second
4. The proportion of men from the cohort who progress to radical prostatectomy, and have whole mount histology that matches the results of the mp-USS, mp-MRI and targeted biopsy.
5. Proportions of adverse events, log of resource utilization and health-related quality-of-life measures on the EQ-5D-5L questionnaire
6. A cohort of men, consented for long-term follow-up and linkage, providing the potential for further translational and clinical studies
Overall trial start date
01/12/2014
Overall trial end date
30/04/2019
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Male
Target number of participants
500 approx.
Participant exclusion criteria
1. Any contraindication to the ultrasound contrast agent including right to left shunt, pulmonary hypertension and uncontrolled hypertension. Also patients with an acute coronary syndrome within the last 6 months or ischaemic heart disease that’s not well controlled by medication.
2. Any form of androgen deprivation or 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. Unable to give informed consent
12. Any other condition the investigator considers would make the patient unsuitable
Recruitment start date
01/03/2016
Recruitment end date
01/01/2018
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University College Hospital London
235, Euston Rd
Fitzrovia
London
NW1 2BU
United Kingdom
Sponsor information
Organisation
UCL Comprehensive Clinical Trials unit
Sponsor details
c/o Susan Tebbs
Comprehensive Clinical Trials Unit
UCL
Gower Street
London
WC1E 6BT
United Kingdom
+44 (0)20 7679 1975
CCTU-enquiries@ucl.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
Prostate Cancer UK
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
United Kingdom
Funder name
Moulton Foundation
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
To be made available at a later date
Basic results (scientific)
Publication list