Phase 1 Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Pasireotide LAR in Patients With Castration Resistant Prostate Cancer

Inclusion Criteria

• •1. ECOG 0 - 2
• •2. Histologically proven adenocarcinoma of the prostate.
• •3. Patients with CRPC (castration resistant prostate cancer): advanced or metastatic adenocarcinoma of the prostate.
• •4. Prior treatment with a GnRH-agonist or GnRH-antagonist for at least 6 months. The medication must not have been changed for at least 3 months prior to start of study treatment.
• •5. Prior treatment with an anti-androgen (e.g. bicalutamide, flutamide, cyproteronacetate) is allowed but not necessary. Patients treated with anti-androgen must have discontinued anti-androgen for at least 6 weeks prior to start of study treatment.
• •1. Dose escalation part only: prior treatment with an anti-androgen and GnRH agonist or antagonist is allowed.
• •2. Dose expansion part only: prior concomitant treatment with an anti-androgen and GnRH agonist or GnRH antagonist for ≤6 weeks is allowed (in order to control flare up).
• •6. Serum testosterone within castration level (\<50 ng/dl or \< 1,7 nM)
• •7. Disease progression demonstrated by a rising PSA with or without metastases. PSA ≥2 ng/mL at study entry. Rising PSA is defined as two consecutive rises over a nadir value; the individual measurements are obtained at least 1 week apart.