Condition category
Cancer
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
28/08/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Dr Peter Hoskin

ORCID ID

Contact details

Marie Curie Research Wing
Mount Vernon Hospital
Rickmansworth Road
Northwood
HA6 2RN
United Kingdom
+44 (0)1923 826111

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 measures

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

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

http://www.doh.gov.uk

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

Results - basic reporting

Publication summary

1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22341794

Publication citations

  1. 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.

Additional files

Editorial Notes