Plain English Summary
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
RDC00707
Study information
Scientific title
Acronym
Study hypothesis
Interstitial 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
Not provided at time of registration
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
Standard external beam radiotherapy 55 Gy (control) versus external beam 34 Gy plus brachytherapy 17 Gy
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
1. 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 measures
Not provided at time of registration
Overall trial start date
07/07/1997
Overall trial end date
07/07/2004
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Patients 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.
Participant type
Patient
Age group
Adult
Gender
Male
Target number of participants
Not provided at time of registration
Participant exclusion criteria
1. Prostate specific antigen (PSA) over 50
2. Previous Transurethral Resection of the Prostate (TURP)
3. Radiological evidence of distant metastasis
Recruitment start date
07/07/1997
Recruitment end date
07/07/2004
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Marie Curie Research Wing
Northwood
HA6 2RN
United Kingdom
Sponsor information
Organisation
NHS R&D Regional Programme Register - Department of Health (UK)
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
NHS Executive London (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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
Basic results (scientific)
Publication list
1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22341794
Publication citations
-
Results
Hoskin PJ, Rojas AM, Bownes PJ, Lowe GJ, Ostler PJ, Bryant L, Randomised trial of external beam radiotherapy alone or combined with high-dose-rate brachytherapy boost for localised prostate cancer., Radiother Oncol, 2012, 103, 2, 217-222, doi: 10.1016/j.radonc.2012.01.007.