Locally advanced or metastatic carcinoma of the prostate.
Conditions
Interventions
Group 1 will be hormonally treated with bicalutamide 150 mg/day monotherapy.
Group 2 will be hormonally treated with bicalutamide 150 mg/day + 0.5 mg dutasteride/day
Sponsors
STIWU: Stichting ter bevordering van het Wetenschappelijk Urologisch onderzoek
(Foundation for the stimulation of Scientific Urological Research.)
Eligibility
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 (> 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 1 year prior to study entry. 3. Development of another invasive neoplastic disease during the previous 5 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
Primary
| Measure | Time frame |
|---|---|
| PSA progression after 3 years of study treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Quality of life 2. Performance Status 3. Disease progression 4. Survival 5. Nature and number of Adverse Events | — |
Contacts
Public ContactW.J. Bruijn, de
CuraTria P.O. Box 30016l
Outcome results
None listed