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.