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.