Local or locally advanced prostate cancer, pN0, M0 Cancer Malignant neoplasm of prostate
Conditions
Interventions
Sponsors
Scandinavian Prostate Cancer Group (SPCG) (Sweden)
Eligibility
Sex/Gender
Male
Inclusion criteria
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
Exclusion criteria
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Denmark, Norway, Sweden
Outcome results
None listed