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
Secondary identifying numbers	N/A

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

https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-trial-looking-at-high-intensity-focused-ultrasound-to-treat-areas-of-prostate-cancer-contained-in-the-prostate-gland

Contact information

Mr Mark Emberton
Scientific

University College London Hospitals NHS Foundation Trust
235 Euston Road
London
NW1 2BU
United Kingdom

Phone	+44 (0)20 7380 9194
Email	mark.emberton@uclh.nhs.uk

Study information

Study design	Interventional phase II single-arm proof of concept single-centre trial
Primary study design	Interventional
Secondary study design	Non randomised study
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details to request a patient 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	To determine patient acceptability, feasibility, and side-effect profile by evaluating: 1. Recording of adverse events 2. Urinary symptoms and erectile function will be assessed at each visit with the following questionnaires: 2.1. International Index of Erectile Function-15 [IIEF-15] 2.2. International Prostate Symptom Score [IPSS] and IPSS - Quality of Life (IPSS-QoL) 2.3. Functional Assessment of Cancer Therapy - Prostate (FACT-P) 2.4. Continence questionnaires
Secondary outcome measures	To determine the effectiveness of therapy by: 1. Post-treatment biopsies of treated areas at 6 months 2. Post-treatment MRI to evaluate area of necrosis within two weeks and at 6 months 3. Measurement of PSA at each follow-up visit and estimated measurement of time to PSA nadir 4. Recording the need for secondary or adjuvant treatment following therapy
Overall study start date	01/06/2007
Completion date	30/05/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Male
Target number of participants	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

England
United Kingdom

Study participating centre

University College London Hospitals NHS Foundation Trust

London
NW1 2BU
United Kingdom

Sponsor information

University College London Hospitals NHS Foundation Trust (UK)
University/education

Research and Development Office
Institute of Child Health
30 Guilford Street
London
WC1N 1EH
England
United Kingdom

Phone	+44 (0)20 7380 9995
Email	nick.mcnally@uclh.nhs.uk
Website	http://www.uclh.nhs.uk/Researchers/RandD+Directorate/
"ROR"	https://ror.org/042fqyp44

Funders

Funder type

Charity

St Peter's Research Trust (UK)

No information available

Pelican Cancer Foundation (UK)
Private sector organisation / Trusts, charities, foundations (both public and private)

Location: United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan	Not provided at time of registration

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
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.