An evaluation of Focal ablation therapy using High-Intensity Focused Ultrasound in the treatment of localised adenocarcinoma of the prostate
| ISRCTN | ISRCTN69304414 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN69304414 |
| Protocol serial number | N/A |
| Sponsor | University College London Hospitals NHS Foundation Trust (UK) |
| Funders | St Peter's Research Trust (UK), Pelican Cancer Foundation (UK) |
- Submission date
- 30/08/2007
- Registration date
- 03/07/2008
- Last edited
- 26/10/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Contact information
Mr Mark Emberton
Scientific
Scientific
University College London Hospitals NHS Foundation Trust
235 Euston Road
London
NW1 2BU
United Kingdom
| Phone | +44 (0)20 7380 9194 |
|---|---|
| mark.emberton@uclh.nhs.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Interventional phase II single-arm proof of concept single-centre trial |
| Secondary study design | Non randomised study |
| Study type | Participant information sheet |
| Scientific title | An evaluation of Focal ablation therapy using High-Intensity Focused Ultrasound in the treatment of localised adenocarcinoma of the prostate |
| Study acronym | Focal-HIFU |
| Study objectives | Do men with early localised prostate cancer (T2c N0 M0 or less), when treated with focal ablation of all cancer foci and a margin of 5 mm normal tissue, using the high-intensity focused ultrasound (HIFU) Sonablate® 500, experience less harm (fewer treatment related toxicities) when compared to conventional whole gland therapies (either radical radiation therapy or surgery)? In addition, is treatment in a focal manner feasible (as laid out in the treatment protocol below) in a manner that allows destruction of those cancer areas? |
| Ethics approval(s) | Joint University College London (UCL)/University College London Hospitals (UCLH) Committees on the Ethics of Human Research (Committee A), ref: 07/Q0505/37 |
| Health condition(s) or problem(s) studied | Localised prostate cancer |
| Intervention | All participants will be treated with HIFU using the Sonablate 500® (Focused Surgery, USA) under general anaesthesia. Only areas of cancer as identified by template biopsies will be treated with a margin of 5 mm normal tissue. Follow-up: 1. MRI at 2 weeks and 6 months 2. Transrectal biopsy at 6 months 3. Clinic visits at 1 month, 3, 6, 9 and 12 months 4. PSA at all clinic visits |
| Intervention type | Other |
| Primary outcome measure(s) |
To determine patient acceptability, feasibility, and side-effect profile by evaluating: |
| Key secondary outcome measure(s) |
To determine the effectiveness of therapy by: |
| Completion date | 30/05/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Male |
| Target sample size at registration | 33 |
| Total final enrolment | 42 |
| Key inclusion criteria | 1. Men aged 45 - 80 years 2. Histological diagnosis of prostate adenocarcinoma 3. Gleason grade total 7 or less (patterns 3+4 or 4+3 or less acceptable) 4. Cancer prostate-confined only (bilateral or unilateral) 5. Serum prostate specific antigen (PSA) less than or equal to 15 ng/mL 6. A life expectancy of 5 years or more 7. Prostate volume less than or equal to 40 cc or maximum anterior-posterior length less than or equal to 40 mm 8. Has had multi-sequence magnetic resonance imaging (ms-MRI) and transperineal template 5 mm spaced biopsies in the 6 months prior to recruitment 9. All malignant areas are treatable by focal ablation so that approximately 50% of prostate tissue is destroyed and at least one neurovascular bundle is preserved 10. Signed informed consent form by patient |
| Key exclusion criteria | 1. Men who have received androgen suppression within previous 6 months 2. Men who have had previous radiation therapy for prostate cancer 3. Men treated with chemotherapy for prostate cancer 4. Men with evidence of metastatic disease 5. Men with latex allergies 6. Men who have undergone prior significant rectal surgery preventing insertion of transrectal probe 7. Men with intraprostatic calcifications making HIFU of focal areas of cancer untreatable 8. Men who have undergone previous transurethral resection of the prostate or laser prostatectomy in the 5 years prior to recruitment 9. Men who have undergone previous HIFU, cryosurgery, thermal or microwave therapy to the prostate at any point prior to recruitment 10. American Society of Anaesthesiology grades III - IV 11. Men not fit for general anaesthesia or regional anaesthesia as assessed by Consultant Anaesthetist 12. Men unable to have MRI scanning (e.g., severe claustrophobia, permanent cardiac pacemaker, metallic implant likely to contribute significant artifact to images) |
| Date of first enrolment | 01/06/2007 |
| Date of final enrolment | 30/05/2009 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
University College London Hospitals NHS Foundation Trust
London
NW1 2BU
United Kingdom
NW1 2BU
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Plain English results | 26/10/2022 | No | Yes |
Editorial Notes
25/10/2022: Cancer Research UK plain English results link and total final enrolment added.
12/10/2017: No publications found, verifying study status with principal investigator.
