Condition category
Cancer
Date applied
30/08/2007
Date assigned
03/07/2008
Last edited
08/09/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Mr Mark Emberton

ORCID ID

Contact details

University College London Hospitals NHS Foundation Trust
235 Euston Road
London
NW1 2BU
United Kingdom
+44 (0)20 7380 9194
mark.emberton@uclh.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

An evaluation of Focal ablation therapy using High-Intensity Focused Ultrasound in the treatment of localised adenocarcinoma of the prostate

Acronym

Focal-HIFU

Study hypothesis

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

Ethics approval received from the Joint University College London (UCL)/University College London Hospitals (UCLH) Committees on the Ethics of Human Research (Committee A) (ref: 07/Q0505/37)

Study design

Interventional, phase II, single-arm, proof of concept, single-centre trial

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Phase II

Drug names

Primary outcome measures

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 trial start date

01/06/2007

Overall trial end date

30/05/2009

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Male

Target number of participants

33

Participant 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)

Recruitment start date

01/06/2007

Recruitment end date

30/05/2009

Locations

Countries of recruitment

United Kingdom

Trial participating centre

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

Sponsor information

Organisation

University College London Hospitals NHS Foundation Trust (UK)

Sponsor details

Research and Development Office
Institute of Child Health
30 Guilford Street
London
WC1N 1EH
United Kingdom
+44 (0)20 7380 9995
nick.mcnally@uclh.nhs.uk

Sponsor type

University/education

Website

http://www.uclh.nhs.uk/Researchers/RandD+Directorate/

Funders

Funder type

Charity

Funder name

St Peter's Research Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Pelican Cancer Foundation (UK)

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes