A comparison of the accuracy of ultrasound scanning and MRI in the detection significant prostate cancer.

ISRCTN	ISRCTN38541912
DOI	https://doi.org/10.1186/ISRCTN38541912
ClinicalTrials.gov number	NCT02712684
Secondary identifying numbers	UCL reference 15/0473

Submission date: 09/03/2016
Registration date: 23/06/2016
Last edited: 24/11/2022

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-study-using-ultrasound-scans-to-diagnose-prostate-cancer-camdus

Contact information

Mr Alistair Grey
Public

Room 4.23
132 Hampstead Rd
London
NW1 2PS
United Kingdom

Phone	+44 (0)20 7679 9092
Email	alistair.grey@ucl.ac.uk

Study information

Study design	Prospective multi-centre cohort diagnostic utility study
Primary study design	Observational
Secondary study design	Cohort study
Study setting(s)	Hospital
Study type	Diagnostic
Participant information sheet	Not currently available in web format. The PIS may be requested from CADMUS@uclh.nhs.uk
Scientific title	Multi-parametric ultrasound targeted biopsies compared to multi-parametric MRI targeted biopsies in the diagnosis of clinically significant prostate cancer
Study objectives	Multiparametric ultrasound has a comparable performance to multiparametric MRI in the detection and risk stratification of prostate lesions that warrant biopsy.
Ethics approval(s)	London (Brent East), 08/10/2015, ref: 15/LO/1331
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase
Drug / device / biological / vaccine name(s)
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 study start date	01/12/2014
Completion date	30/04/2019

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Male
Target number of participants	500 approx.
Total final enrolment	370
Key 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
Key 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
Date of first enrolment	01/03/2016
Date of final enrolment	01/01/2018

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

University College Hospital London

235, Euston Rd
Fitzrovia
London
NW1 2BU
United Kingdom

Sponsor information

UCL Comprehensive Clinical Trials unit
University/education

c/o Susan Tebbs
Comprehensive Clinical Trials Unit
UCL
Gower Street
London
WC1E 6BT
England
United Kingdom

Phone	+44 (0)20 7679 1975
Email	CCTU-enquiries@ucl.ac.uk
"ROR"	https://ror.org/02jx3x895

Funders

Funder type

Charity

Prostate Cancer UK
Private sector organisation / Other non-profit organizations

Alternative name(s): Prostate Cancer, Prostate Action, ProstateUK, prostatecanceruk
Location: United Kingdom

Moulton Foundation

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Data sharing statement to be made available at a later date
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan	Not provided at time of registration

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	protocol	01/03/2018	30/11/2020	Yes	No
Results article		01/03/2022	04/03/2022	Yes	No
Plain English results			24/11/2022	No	Yes
HRA research summary			28/06/2023	No	No

Editorial Notes

24/11/2022: Added link to plain English results.
04/03/2022: The following changes have been made:
1. Publication reference added.
2. The total final enrolment number has been added from the reference.
3. The ClinicalTrials.gov number has been added from the reference.
04/06/2021: The contact details were updated.
30/11/2020: Publication reference added.
18/02/2019: The overall trial end date was changed from 01/02/2018 to 30/04/2019.
18/10/2017: Internal review.
24/11/2016: Cancer Help UK Lay summary link added.