Prostate cancer Cancer
Conditions
Interventions
This study will ask patients who have already agreed to undergo focal therapy at our hospital to take part. These patients will be identified from our prostate multidisciplinary meeting, outpatient cl
Sponsors
Imperial College London
Eligibility
Sex/Gender
Male
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Age 18 years or above (no upper limit) 2. Patients with localised prostate cancer defined as a T-stage of T1-T3a and PSA < = 20 ng/mL, either newly-diagnosed or on active surveillance 3. Patients suitable for and booked to undergo focal HIFU, cryotherapy, or irreversible electroporation for localised prostate cancer, with or without neoadjuvant androgen-deprivation therapy. ‘Focal’ is defined as ablation delivered to a maximum of three quarters of the prostate
Exclusion criteria
Exclusion criteria: 1. Unable to give consent 2. Patients undergoing surgery for symptoms of bladder outlet obstruction, for example transurethral resection of the prostate, at time of focal therapy 3. Any previous local therapy for prostate cancer, including radiotherapy (external-beam radiotherapy or brachytherapy), radical prostatectomy, and ablative treatments 4. Any surgery for benign prostatic obstruction within the previous 6 months 5. Any contraindication to receiving the sulphur hexafluoride ultrasound contrast agent including evolving or ongoing myocardial infarction, typical angina at rest, significant worsening of cardiac symptoms, recent coronary artery intervention, acute cardiac failure, class III/IV cardiac failure, severe cardiac arrhythmias, right-to-left shunts, severe pulmonary hypertension (pulmonary artery pressure > 90 mmHg), uncontrolled systemic hypertension, and adult respiratory distress syndrome 6. Unable to undergo MRI, including intravenous administration of gadolinium-based contrast
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with clinically-significant prostate cancer within the treatment zone on biopsy at 12 months, defined as cancer that is grade group 2 or higher, in those patients who undergo prostate biopsy. Timepoint: 12 months post-operatively | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Recruitment rate: the percentage of approached patients who consent to participate per month. Timepoint: baseline 2. Biopsy rate: the number of patients who agree and disagree to undergo prostate biopsy at 12 months, with reasons if disagreement. Timepoint: 12 months post-operatively 3. Proportion of patients with clinically-insignificant prostate cancer within the treatment zone on biopsy at 12 months, defined as cancer that is grade group 1, in those patients having a biopsy. Timepoint: 12 months post-operatively 4. Proportion determined by the treating urologist that the CEUS performed after focal therapy is negative, equivocal, or suspicious for residual tumour. Timepoint: day 0 (intra-operatively) 5. Proportion undergoing further ablation by the treating urologist after performing intra-operative CEUS. Timepoint: day 0 (intra-operatively) 6. The time in minutes required to set up and perform CEUS intra-operatively pre-focal therapy. Timepoint: day 0 (intra-operatively) 7. The time in minutes required to set up and perform CEUS intra-operatively post-focal therapy. Timepoint: day 0 (intra-operatively) 8. The time in minutes required to deliver further ablation, if performed. Timepoint: day 0 (intra-operatively) 9. Temporal changes in time required to set up and perform intra-operative CEUS, measured on a per-urologist basis. Timepoint: day 0 (intra-operatively) 10. Agreement over CEUS image interpretation score between the treating urologist and an expert user, measured on a per-urologist basis. Timepoint: day 0 (intra-operatively) 11. Proportion of individual CEUS steps performed to completion, assessed by an expert user. Timepoint: day 0 (intra-operatively) 12. Proportion of individual CEUS steps performed to optimal quality, assessed by an expert user. Timepoint: day 0 (intra-operatively) 13. Proportion of CEUS images with suspicion score concordant with a score given by an expert user. Timepoint: day 0 (intra-operatively) 14. Pro | — |
Countries
United Kingdom
Contacts
Public ContactAlexander Light
Outcome results
None listed