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. Exclusion criteria: 1. Dose expansion part only: Secondary hormonal manipulation of prostate cancer (other than GnRH agonist or antagonist) for more than 6 weeks, including concomitant anti-androgens. 2. Prior cytotoxic therapy e.g. with docetaxel, mitoxantrone. 3. Patients who have received radiotherapy of target lesions. Patients who have received local radiotherapy of non-target lesions for local symptom control within the last 4 weeks must have recovered from any adverse effects of radiotherapy before recording baseline symptoms. Lesions treated with locoregional therapies within the last 3 months before study inclusion do not qualify as target lesions. Additional protocol-defined inclusion/exclusion criteria apply.