Condition category
Cancer
Date applied
09/03/2016
Date assigned
23/06/2016
Last edited
24/11/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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) 2076799092
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), 8/10/2015, 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 measures

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

01/02/2018

Reason abandoned

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

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
020 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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

24/11/2016: Cancer Help UK Lay summary link added