A prospective study to compare immediate with deferred treatment in advanced, localised and asymptomatic metastatic newly diagnosed prostatic carcinoma
| ISRCTN | ISRCTN14557194 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14557194 |
| Protocol serial number | PR03 |
| Sponsor | Medical Research Council (MRC) (UK) |
| Funder | Medical Research Council |
- Submission date
- 19/08/2002
- Registration date
- 19/08/2002
- Last edited
- 15/11/2019
- 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
Not provided at time of registration
Contact information
Dr - -
Scientific
Scientific
UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | A prospective study to compare immediate with deferred treatment in advanced, localised and asymptomatic metastatic newly diagnosed prostatic carcinoma |
| Study objectives | Not provided at time of registration. |
| Ethics approval(s) | Not provided at time of registration. |
| Health condition(s) or problem(s) studied | Prostate cancer |
| Intervention | 1. Immediate Group: Total or subcapsular orchidectomy or administration of a Lutenizing Hormone Releasing Hormone (LHRH) analogue. Suggested LHRH analogues are goserelin acetate (Zoladex) 3.6 mg monthly or leuprorelin (Prostap SR) 3.75 mg monthly. LHRH treatment to start within 6 weeks of randomisation. 2. Deferred Group: No hormone treatment until disease progression. The original protocol specified orchidectomy only as the method of androgen deprivation. The protocol was later modified to allow the use of LHRH analogues. |
| Intervention type | Mixed |
| Primary outcome measure(s) |
Not provided at time of registration. |
| Key secondary outcome measure(s) |
Not provided at time of registration. |
| Completion date | 01/08/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Male |
| Target sample size at registration | 938 |
| Total final enrolment | 938 |
| Key inclusion criteria | 1. Histologically proven adenocarcinoma of the prostate 2. Stage T2-T4 M0 or T1-T4 M1 (provided metastases are asymptomatic) 3. World Health Organisation (WHO) performance status 0-2 4. Life expectancy of >1 year 5. No previous or coexisting non prostatic malignancy except basal cell carcinoma 6. No previous treatment for prostatic carcinoma other than transurethral resection (TUR) 7. Patients in whom a deferred policy is inappropriate should not be entered into this study |
| Key exclusion criteria | Not provided at time of registration. |
| Date of first enrolment | 01/08/2000 |
| Date of final enrolment | 01/08/2005 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom
NW1 2DA
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/02/1997 | 15/11/2019 | Yes | No |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
15/11/2019: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
