Docetaxel and Gemcitabine in Hormonal Refractory Metastatic Prostate Cancer

Inclusion Criteria

• •Histologically verified adenocarcinoma of the prostate.
• •Hormone refractory prostate cancer (HRPC) defined as progression during previous anti-hormone treatment. Patients must have been off previous anti-androgen therapy for more than 4 weeks.
• •Stage IV disease (verified by imaging or clinical examination).
• •PSA \> 10 microgram/l.
• •PSA progression defined as a \> 25% increase between two independent measurements performed with a 1-month interval or more after discontinuation of anti-androgen treatment.
• •Castrate level of testosterone (\< 50 ng).
• •No previous oestrogen or steroid as metastatic prostate cancer treatment.
• •Satisfactory hepatic function in the form of total bilirubin ≤ UNL (upper normal limit), ASAT/ALAT ≤ 2.5 x UNL, alkaline phosphatase ≤ 5 x UNL.
• •Satisfactory renal function, defined as serum creatinine ≤ 1.5 x UNL.
• •Satisfactory haematologic function defined as ANC \>1.5 x 10\^9/l, leucocytes \>3.0 x 10\^9/l, thrombocytes ≥ 100 x 10\^9/l, haemoglobin \> 7 mmol/l
• •ECOG performance status ≤ 2.
• •Life expectancy \> 3 months.
• •Patient must be able to adhere to protocol requirements.
• •Written informed consent.
• •\> 18 years of age.