Prostate cancer Cancer Malignant neoplasm of prostate
Conditions
Interventions
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 m
Sponsors
UCL Comprehensive Clinical Trials unit
Eligibility
Sex/Gender
Male
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
England, United Kingdom
Contacts
Public ContactAlistair Grey
Outcome results
None listed