A randomised trial of total prostatectomy versus radiotherapy versus no immediate treatment in early prostate cancer
| ISRCTN | ISRCTN81687381 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN81687381 |
| Secondary identifying numbers | PR06 |
- Submission date
- 06/04/2000
- Registration date
- 06/04/2000
- Last edited
- 19/09/2017
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr Robert Shearer
Scientific
Scientific
Department of Urology
The Royal Marsden
Fullham Road
London
SW3 6JJ
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Not Specified |
| Scientific title | A randomised trial of total prostatectomy versus radiotherapy versus no immediate treatment in early prostate cancer |
| Study objectives | To determine whether total prostatectomy or radiotherapy confer benefit in terms of survival or development of metastases over no immediate treatment alone. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Prostate cancer |
| Intervention | 1. The first group receives total prostatectomy 2. The second receive radiotherapy 3. The third receive no immediate treatment |
| Intervention type | Other |
| Primary outcome measure | 1. Survival time to metastases 2. Morbidity 3. Local recurrence 4. Quality of life 5. Time to progression |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/06/1994 |
| Completion date | 01/06/1996 |
| Reason abandoned (if study stopped) | The overall target for recruitment was 1800 patients, but the trial accrued only 35 (mean age 69 years, median PSA level at entry 12 ng/mL). Recruitment was formally halted following the recommendation of the independent Data Monitoring Committee in October 1996. |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Male |
| Target number of participants | 1800 planned, 35 recruited at time of early closure in 1996. |
| Key inclusion criteria | 1. Newly diagnosed, biopsy-proven adenocarcinoma of the prostate 2. Stage T1b/T1c/T2, N0, M0 3. Negative bone scan 4. No previous malignancy (except skin) |
| Key exclusion criteria | Opposite of inclusion criteria |
| Date of first enrolment | 01/06/1994 |
| Date of final enrolment | 01/06/1996 |
Locations
Countries of recruitment
- Belgium
- England
- Switzerland
- United Kingdom
Study participating centre
Department of Urology
London
SW3 6JJ
United Kingdom
SW3 6JJ
United Kingdom
Sponsor information
Medical Research Council (MRC) (UK)
Research council
Research council
20 Park Crescent
London
W1B 1AL
United Kingdom
| Phone | +44 (0)20 7636 5422 |
|---|---|
| clinical.trial@headoffice.mrc.ac.uk | |
| Website | http://www.mrc.ac.uk |
Funders
Funder type
Research council
Medical Research Council (UK)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- Medical Research Council (United Kingdom), UK Medical Research Council, MRC
- Location
- United Kingdom
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Other publications | Early closure in reported in 2004 | 01/12/2004 | Yes | No |
Editorial Notes
19/09/2017: internal review.
