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. Exclusion Criteria: Previous prostate cancer treatment with oestrogens or steroid hormones. Previous chemotherapy. Previous treatment with systemic radioactive isotopes. Bisphosphonate treatment (concomitant). Radiation therapy covering more than 25% of the bone marrow producing area. Other serious coincidental and/or concomitant medical condition. Symptomatic cerebral metastases. Other previous or current malignant disease, excluding *adequately treated and cured planocellular skin carcinoma; or *other cancer assessed to carry minimal risk of recurrence. ECOG performance status > 2.