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
Contact information
Dr Peter Hoskin
Scientific
Scientific
Marie Curie Research Wing
Mount Vernon Hospital
Rickmansworth Road
Northwood
HA6 2RN
United Kingdom
| Phone | +44 (0)1923 826111 |
|---|---|
| a@b.com |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 | 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 study start date | 07/07/1997 |
| Completion date | 07/07/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Male |
| Target number of participants | Not provided at time of registration |
| 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
- England
- United Kingdom
Study participating centre
Marie Curie Research Wing
Northwood
HA6 2RN
United Kingdom
HA6 2RN
United Kingdom
Sponsor information
NHS R&D Regional Programme Register - Department of Health (UK)
Government
Government
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| 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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
| 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.
