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

ISRCTN	ISRCTN98241100
DOI	https://doi.org/10.1186/ISRCTN98241100
Protocol serial number	RDC00707
Sponsor	NHS R&D Regional Programme Register - Department of Health (UK)
Funder	NHS Executive London (UK)

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Randomised trial of interstitial brachytherapy as a component of radical radiotherapy for localised prostatic carcinoma
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Prostate cancer
Intervention	Standard external beam radiotherapy 55 Gy (control) versus external beam 34 Gy plus brachytherapy 17 Gy
Intervention type	Other
Primary outcome measure(s)	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
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	07/07/2004

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Male
Total final enrolment	218
Key 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.
Key exclusion criteria	1. Prostate specific antigen (PSA) over 50 2. Previous Transurethral Resection of the Prostate (TURP) 3. Radiological evidence of distant metastasis
Date of first enrolment	07/07/1997
Date of final enrolment	07/07/2004

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Marie Curie Research Wing

Northwood
HA6 2RN
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan	Not 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
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
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.