A Single Stage Phase II, Multi-centre, Open Label Study of Imatinib in Combination With Pioglitazone, Etoricoxib, Dexamethasone and Low-dose Treosulfane for Anti-inflammatory and Angiostatic Treatment in Patients With Hormone-refractory Prostate Cancer
- Histologically confirmed prostate carcinoma, which has proven progression after
primary hormone therapy (surgical or medicinal castration).
- Patients must have increasing PSA levels (within 3 months prior to enrollment) with
at least two consecutively increasing PSA levels.
- PSA value before inclusion must be at least 5 ng/ml
- At least 18 years of age.
- At least capable of self care and up of at least 50% of waking hours (ECOG
performance status 0 - 2), adequate bone marrow function and lab results.
- Change of hormone therapy within 6 weeks prior inclusion
- Prior chemotherapy
- Therapy with Imatinib, or therapy with other inhibitors of tyrosinkinase.
- Second neoplasm diagnosed within 5 years before study start.
- Patients who require therapy with warfarin
- Known diagnosis of HIV, hepatitis B, or hepatitis C infection.
- Severe, unstable, or uncontrolled medical disease which would confound diagnoses or
evaluations required by the protocol, including severe cardiac insufficiency
- Surgical therapy within 4 weeks before inclusion.
- Prior therapy with isotopes strontium or rhenium.
- Radiation therapy to > 25% of bone marrow within 4 weeks before inclusion.
- Treatment with other experimental substances within 30 days before study start.
Other protocol-defined inclusion/exclusion criteria may apply