A randomised trial comparing hormonal treatment versus combination of hormonal treatment and radiotherapy in locally advanced prostate cancer
| ISRCTN | ISRCTN01534787 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN01534787 |
| Secondary identifying numbers | Version 1996 01 09 |
- Submission date
- 29/05/2008
- Registration date
- 13/06/2008
- Last edited
- 08/04/2009
- 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
Not provided at time of registration
Contact information
Prof Anders Widmark
Scientific
Scientific
Department of Radiation Sciences, Oncology
Umeå University, Hospital
Umeå
90185
Sweden
| Anders.Widmark@onkologi.umu.se |
Study information
| Study design | A randomised open, comparative, parallel design 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 (only in Swedish, Norwegian and Danish) |
| Scientific title | Randomised trial of locally advanced/aggressive prostatic cancer: T3 diff grad 1-3, T1b - T2 diff grad 2-3 (optional), NO, MO antiandrogen treatment with or without radiotherapy |
| Study acronym | SPCG-7/SFUO-3 |
| Study hypothesis | To evaluate if the addition of radiotherapy improves the outcome in hormonally-treated, locally advanced/aggressive, node-negative and non-metastasised prostatic cancer. |
| Ethics approval(s) | Ethics approval received from Umeå University, Medical Faculty Ethical Committee in 1995 (ref: paragraph 247/95; diary no. 95-179). |
| Condition | Local or locally advanced prostate cancer, pN0, M0 |
| Intervention | After randomisation all patients were treated with total androgen blockade (TAB) with an LHRH-agonist (Procren Depot; Abbott), for three months in combination with an oral anti-androgen (AA) Eulexin (Schering-Plough) 250 mg x 3. Thereafter all patients continued on the anti-androgen alone, T Eulexin 250 mg x 3 daily, continuously until progression. After three months patients in the Radiotherapy+Hormone arm started radiotherapy whereas patients in the Hormone-only arm had no local treatment. Minimal radiation dose to the prostate will be 70 Gy and the seminal vesicles will be included up to a minimum dose of 50 Gy. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Leuprolide (Procren Depot), flutamide (Eulexin) |
| Primary outcome measure | To evaluate if cause-specific seven-year survival can be improved in patients treated with a combination of radiotherapy and anti-androgen as compared to anti-androgen therapy only. Primary and secondary endpoints were planned to be analysed after seven years. |
| Secondary outcome measures | 1. To evaluate: 1.1. Time to biochemical progression (PSA) 1.2. Time to symptoms related to local progression 1.3. Time to symptoms related to distant progression 2. To evaluate quality of life (QOL) with special focus on sexual function, urinary and gastrointestinal morbidity Primary and secondary endpoints were planned to be analysed after seven years. |
| Overall study start date | 27/02/1996 |
| Overall study end date | 30/12/2002 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Male |
| Target number of participants | Initilly 660, later enlarged to 880, due to fewer events than expected |
| Participant inclusion criteria | 1. Men less than 76 years of age and, as judged by the doctor, a life expectancy of less than 10 years (except for cancer) at time of randomisation with performance status World Health Organization (WHO) 0 - 2 2. Patients with histologically/cytologically verified prostatic cancer 3. Patients with prostatic cancer of clinical category T1b-T2; G2-G3 and T3; G1-G3 according to the TNM classification system of 1992. Inclusion of patients with T1b-T2; G3 and T2; G2 is optional. 4. The patients should have no evidence of metastases by clinical investigation, bone scan or pulmonary x-ray 5. Patients should be lymph node negative 6. Patients should be suitable for radiotherapy and anti-androgen treatment |
| Participant exclusion criteria | 1. Patients who earlier have undergone any other treatment against prostatic cancer except transurethral resection of the prostate (TUR-P) 2. Patients with a prostate specific antigen (PSA) greater than 70 ng/ml 3. Patients unable to cooperate or suffering from any other form of disease that would interfere with the planned treatment (e.g. colitis) 4. Liver function that would interfere with the anti-androgen treatment (a bilirubin and/or alanine aminotransferase [ALAT] value above the upper normal limit) 5. Patients with previous diagnosis of other malignant disease. Exceptions could be made for basal cell carcinoma of the skin or progression free survival at least 10 years after any previous tumour (this requires discussion with the study co-ordinator). |
| Recruitment start date | 27/02/1996 |
| Recruitment end date | 30/12/2002 |
Locations
Countries of recruitment
- Denmark
- Norway
- Sweden
Study participating centre
Department of Radiation Sciences, Oncology
Umeå
90185
Sweden
90185
Sweden
Sponsor information
Scandinavian Prostate Cancer Group (SPCG) (Sweden)
Research organisation
Research organisation
c/o P.O.Hedlund
Skogsstigen 22
131 42 Nacka
Stockholm
103 42
Sweden
| Website | http://www.spcg.se |
|---|
Funders
Funder type
Research organisation
Scandinavian Prostate Cancer Group (SPCG) (Sweden) - after receiving an unrestricted grant from Schering-Plough Inc. and Abbott Scandinavia Inc.
No information available
Nordic Cancer Union (Norway)
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 24/01/2009 | Yes | No | |
| Results article | four-year follow-up results | 01/04/2009 | Yes | No |
