Condition category
Cancer
Date applied
11/03/2008
Date assigned
16/05/2008
Last edited
08/02/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Dr David Bottomley

ORCID ID

Contact details

St. James' University Hospital
68 Beckett Street
Leeds
LS9 0AB
United Kingdom
+44 (0)113 2067854
david.bottomley@leedsth.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Randomised controlled trial of brachytherapy versus radical prostatectomy in good risk prostate cancer: a feasibility 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

To be submitted to Southampton & South West Hampshire Research Ethics Committee in May 2008 – pending

Study design

Randomised controlled trial.

Primary study design

Interventional

Secondary study design

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

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

Phase

Drug names

Primary outcome measures

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 trial start date

01/06/2008

Overall trial end date

01/06/2013

Reason abandoned

Eligibility

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 type

Patient

Age group

Adult

Gender

Male

Target number of participants

400

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, United Kingdom

Trial participating centre

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

Sponsor information

Organisation

Southampton University Hospitals NHS Trust (UK)

Sponsor details

Trust Management Offices
MP18
Southampton General Hospital
Tremona Road
Southampton
SO16 6YD
United Kingdom
+44 (0)2380 794752
christine.mcgrath@suht.swest.nhs.uk

Sponsor type

Government

Website

http://www.suht.nhs.uk

Funders

Funder type

Charity

Funder name

Cancer Research UK (CRUK) (UK)

Alternative name(s)

CRUK

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

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

2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23826842

Publication citations

Additional files

Editorial Notes

RP 08/02/2016: Publication reference added. On 17/02/2011 the overall trial end date was changed from 01/06/2012 to 01/06/2013.