SABRE 1: Surgery Against Brachytherapy - a Randomised Evaluation

ISRCTN	ISRCTN88144169
DOI	https://doi.org/10.1186/ISRCTN88144169
ClinicalTrials.gov number	NCT01098331
Secondary identifying numbers	N/A

Submission date: 11/03/2008
Registration date: 16/05/2008
Last edited: 14/02/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English Summary

http://www.cancerhelp.org.uk/trials/a-study-looking-at-giving-men-with-prostate-cancer-a-dvdvideo-on-treatment-for-prostate-cancer-and-the-possibility-of-a-study-comparing-2-different-treatments-for-prostate-cancer

Study website

Contact information

Dr David Bottomley
Scientific

St. James' University Hospital
68 Beckett Street
Leeds
LS9 0AB
United Kingdom

Phone	+44 (0)113 2067854
Email	david.bottomley@leedsth.nhs.uk

Study information

Study design	Randomised controlled trial.
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Randomised controlled trial of brachytherapy versus radical prostatectomy in good risk prostate cancer: a feasibility study
Study acronym	SABRE 1
Study hypothesis	1. In men with localised prostate cancer, will the addition of a decision aid to standard information improve accrual to a randomised trial of radical prostatectomy versus brachytherapy? 2. Is it feasible to perform a phase III randomised controlled trial of brachytherapy versus radical prostatectomy in men with localised prostate cancer?
Ethics approval(s)	To be submitted to Southampton & South West Hampshire Research Ethics Committee in May 2008 – pending
Condition	Prostate cancer
Intervention	This trial includes two stages of randomisation. Randomisation 1: Participants are initially randomised to either receive standard patient information or to receive the standard patient information plus the decision aid. The decision aid is a DVD or video that the participant is able to watch at home. Randomisation 2: Participants that then choose to enter the treatment randomisation stage will be randomised to undergo either radical prostatectomy or brachytherapy. Radical prostatectomy: The surgical technique may be either open or retropubic and will take place within 60 days of randomisation. Pelvic lymph node surgery is permitted at the discretion of the treating surgeon. Unilateral or bilateral nerve sparing techniques may also be used at the discretion of the surgeon. Brachytherapy: Will be performed within 60 days of randomisation. It will be performed under general or regional anaesthesia. Intravenous antibiotic coverage such as gentamycin is recommended at induction of anaesthetic. In addition oral ciprofloxacin 500 mg twice a day (bd) for 7 days is recommended. Transrectal ultrasound probe attached to a stabilised stepping unit should be used. Planning must be via transrectal ultrasound. The urethra should be visualised using aerated gel in a catheter. The isotope to be used is either iodine-125 or palladium-103. Seeds may be implanted using pre-loaded needles or a MICK applicator. For palladium-103 the dose will be 125.00 Gy, minimum peripheral dose. For iodine-125 the minimum peripheral dose will be 145.00 Gy. Peripheral loading is advisable to limit the dose to the urethra to less than or equal to 150% of the prescribed dose. The seed activity for palladium-103 is 1-1.6 millicuries and for iodine-125 is 0.28-0.5 millicuries per seed.
Intervention type	Mixed
Primary outcome measure	Decision aid randomisation: Proportion of patients consenting to the treatment randomisation Treatment randomisation: Feasibility of randomisation in terms of average accrual rate per centre during the last 6 months of recruitment.
Secondary outcome measures	Decision aid randomisation: Decisional quality post-treatment Treatment randomisation: 1. Compliance with allocated treatment 2. Clinical failure. Duration of follow-up: 10 years 3. PSA relapse. Duration of follow-up: 10 years 4. Patient-reported quality of life at 5 years (see below for details) 5. Toxicity. Duration of follow-up: 10 years Quality of life will be measured using a 50-question document to include the following: a. The 12-item short form health survey (SF-12; General quality of life) b. European Quality of Life questionnaires (EQ-5D; General quality of life to tie in with health economic data) c. The International Continence Society 'male short-form' (ICSmaleSF) questionnaire (urinary functioning) d. Vaizey Questionnaire (A short, validated bowel function questionnaire) e. The International Index of Erectile Function (IIEF5) The questionnaires will be amalgamated into one single 50-question document which will be administered as a single questionnaire at each assessment point. Quality of Life questionnaire compliance will be carefully monitored during this feasibility trial; this and clinical outcomes will be used as one basis for the sample size calculation for the SABRE 2 phase III trial.
Overall study start date	01/06/2008
Overall study end date	01/06/2013

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Male
Target number of participants	400
Participant inclusion criteria	1. Suspected prostate cancer that is confined to the prostate 2. Due for prostate biopsy 3. World Health Organisation performance status 0 - 1 4. Prostate-Specific Antigen (PSA) less than 15 ng/ml 5. Life expectancy more than 10 years 6. Written informed consent Inclusion criteria for treatment randomisation: 1. Participation in decision aid randomisation 2. Histologically confirmed prostate cancer 3. Clinical T stage T1/T2 4. Either Gleason score less than or equal to 6 with a PSA of less than 15 or Gleason score 3 + 4 in less than 50% of the cores with a PSA less than 10 (PSA test less than 3 months prior to treatment intervention)
Participant exclusion criteria	1. Unacceptable risk for radical prostatectomy 2. Unacceptable risk for brachytherapy 3. Prior pelvic radiotherapy 4. Other active malignancy likely to interfere with subsequent protocol treatment and follow-up 5. Previous abdominoperineal (AP) rectal excision 6. Previous transurethral resection of their prostate gland (TURP) 7. Significant obstructive urinary symptoms (peak urine flow rate less than 10 ml per second, post micturition bladder volume greater than 75 ml) 8. Severe lower urinary tract symptoms 9. Inability to attend or comply with treatment or follow-up scheduling
Recruitment start date	01/06/2008
Recruitment end date	01/06/2013

Locations

Countries of recruitment

Canada
England
United Kingdom

Study participating centre

St. James' University Hospital

Leeds
LS9 0AB
United Kingdom

Sponsor information

Southampton University Hospitals NHS Trust (UK)
Hospital/treatment centre

Trust Management Offices, MP18
Southampton General Hospital
Tremona Road
Southampton
SO16 6YD
England
United Kingdom

Phone	+44 (0)2380 794752
Email	christine.mcgrath@suht.swest.nhs.uk
Website	http://www.suht.nhs.uk
"ROR"	https://ror.org/0485axj58

Funders

Funder type

Charity

Cancer Research UK (CRUK) (UK)
Private sector organisation / Other non-profit organizations

Alternative name(s): CR_UK, Cancer Research UK - London, CRUK
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

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Plain English results				No	Yes
Results article	results	01/08/2013		Yes	No

Editorial Notes

14/02/2020: ClinicalTrials.gov number added.
26/10/2018: Cancer Research UK lay results summary link added to Results (plain English)
08/02/2016: Publication reference added.
17/02/2011: The overall trial end date was changed from 01/06/2012 to 01/06/2013.