Cancer Diagnosis by Multiparametric UltraSound of the Prostate

• Conditions: Prostate Cancer

• Registration Number: NCT02712684
• Lead Sponsor: University College, London

Brief 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?

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 Timeline

• Study Start: 2015-07
• Study First Submitted: 2016-02-04
• Study First Submitted QC: 2016-03-14
• Study First Posted: 2016-03-18
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-08
• Last Update Posted: 2016-08-09
• Primary Completion: 2017-05
• Study Completion: 2017-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 500

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

Exclusion Criteria

1. 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.
2. Any form of 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. 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
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.	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

Secondary Outcome Measures

Name	Time	Method
To compare the overall agreement in proportion of men diagnosed with other thresholds of clinically significant prostate cancer on biopsy	at time of surgery	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
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	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	at time of surgery	clinically significant cancer (using all of the pre-specified definitions based on histology)
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.	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	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.	at time of surgery

Trial Locations

Locations (1)

University College London Hospitals; 🇬🇧 London,, England, United Kingdom