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

Not Applicable

Completed

• Conditions: Prostate cancer; Cancer; Malignant neoplasm of prostate

• Registration Number: ISRCTN38541912
• Lead Sponsor: CL Comprehensive Clinical Trials unit

Brief Summary

2018 Protocol article in https://pubmed.ncbi.nlm.nih.gov/29108869/ protocol (added 30/11/2020) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35240084/ (added 04/03/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-06-23
• Study Completion: 2019-04-30
• Last Update Posted: 5 December 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 370

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 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 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

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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).