Prostate Cancer Cancer Prostate cancer
Conditions
Interventions
Group one will be hormonally treated with bicalutamide 150 mg/day monotherapy.
Group two will be hormonally treated with bicalutamide 150 mg/day and 0.5 mg dutasteride/day.
Sponsors
Foundation for the Promotion of Urological Scientific Research (STIWU) (The Netherlands)
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Patients aged 18 years and above 2. Patients with histologically proven prostate cancer 3. Patients with locally advanced carcinoma of the prostate (T3-4, N0-x) or (T0-x, N1-3; N category should be confirmed histologically or cytologically) or metastatic carcinoma of the prostate (M1) 4. Patients with a high (more than 10 ng/ml) PSA level at baseline 5. Written informed consent to participate in the study 6. Life expectancy is at least 12 months
Exclusion criteria
Exclusion criteria: 1. Patients simultaneously participating in another study 2. Previous or concurrent chemotherapy, 5-alpha reductase inhibitor therapy or hormonal therapy specifically for the treatment of prostate cancer other than temporary neo-adjuvant hormonal therapy administered longer than one year prior to study entry 3. Development of another invasive neoplastic disease during the previous five years, or concomitant presence of another invasive neoplastic disease, except basal cell carcinoma or squamous cell carcinoma of the skin 4. Patients with a history or presence of hepatic or renal disease or other condition known to interfere with metabolism or excretion of drugs 5. Patients with a history of alcohol or drug abuse
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| 1. Quality of life 2. Performance Status 3. Disease progression 4. Survival 5. Nature and number of Adverse Events (AEs) | — |
Primary
| Measure | Time frame |
|---|---|
| PSA progression after three years of study treatment. | — |
Countries
Netherlands
Outcome results
None listed