Randomised trial of interstitial brachytherapy as a component of radical radiotherapy for localised prostatic carcinoma

ISRCTN ISRCTN98241100
DOI https://doi.org/10.1186/ISRCTN98241100
Secondary identifying numbers RDC00707
Submission date
23/01/2004
Registration date
23/01/2004
Last edited
29/10/2021
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 of protocol

http://cancerhelp.cancerresearchuk.org/trials/a-trial-looking-at-external-radiotherapy-with-or-without-internal-radiotherapy-for-prostate-cancer

Contact information

Dr Peter Hoskin
Scientific

Marie Curie Research Wing
Mount Vernon Hospital
Rickmansworth Road
Northwood
HA6 2RN
United Kingdom

Phone +44 (0)1923 826111
Email a@b.com

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleRandomised trial of interstitial brachytherapy as a component of radical radiotherapy for localised prostatic carcinoma
Study objectivesInterstitial brachytherapy provides a means of delivering high dose radiation accurately localised by radio-active sources placed directly within a tumour. New techniques, in particular transrectal ultrasound allow this to be performed accurately within the prostate gland. It is not clear whether this improves the results over conventional external beam treatment alone and this randomised comparative trial is underway to assess this.
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedProstate cancer
InterventionStandard external beam radiotherapy 55 Gy (control) versus external beam 34 Gy plus brachytherapy 17 Gy
Intervention typeOther
Primary outcome measure1. An improvement in local control for prostatic carcinoma as defined by:
a. PSA response
b. Changes on digital rectal examination
c. Local symptom-free duration
d. Quality of Life (FACT-P)
2. Prolonged disease specific survival consequent upon the improved local survival
3. Reduced bowel morbidity because of the more localised nature of the interstitial component of the radiation dose delivered
Secondary outcome measuresNot provided at time of registration
Overall study start date07/07/1997
Completion date07/07/2004

Eligibility

Participant type(s)Patient
Age groupAdult
SexMale
Target number of participantsNot provided at time of registration
Total final enrolment218
Key inclusion criteriaPatients with prostatic carcinoma who after routine staging have no evidence of distant metastasis. Patients will be male and over 40 years of age. In general external beam treatment is delivered as an outpatient whilst the interstitial treatment will require two to three days inpatient care.
Key exclusion criteria1. Prostate specific antigen (PSA) over 50
2. Previous Transurethral Resection of the Prostate (TURP)
3. Radiological evidence of distant metastasis
Date of first enrolment07/07/1997
Date of final enrolment07/07/2004

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Marie Curie Research Wing
Northwood
HA6 2RN
United Kingdom

Sponsor information

NHS R&D Regional Programme Register - Department of Health (UK)
Government

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone +44 (0)20 7307 2622
Email dhmail@doh.gsi.org.uk
Website http://www.doh.gov.uk

Funders

Funder type

Government

NHS Executive London (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing planNot provided at time of registration

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/05/2012 Yes No
Results article results 01/08/2019 08/05/2019 Yes No
Plain English results 31/08/2005 29/10/2021 No Yes

Editorial Notes

29/10/2021: The Cancer Research UK lay results summary has been added.
08/05/2019: Total final enrolment and publication reference were added.