An open label phase I/randomised, double-blind phase II study in metastatic castration resistant Prostate Cancer of AZD5363 in combination with Docetaxel and prednisolone chemotherapy (ProCAID)

INTERVENTION: IMP, AZD5363 CONDITION: Topic: National Cancer Research Network; Subtopic: Prostate Cancer; Disease: Prostate ; Cancer ; Malignant neoplasm of prostate PRIMARY OUTCOME: Determination of a suitable dose of AZD5363; Timepoint(s): Phase I SECONDARY OUTCOME: 1. AZD5363 pharmacokinetics in combination with DP; Timepoint(s): Phase I; 2. Biochemical (PSA) response rates according to PCWG2 criteria; Timepoint(s): Phase II; 3. Bone pain changes using the BPI Questionnaire; Timepoint(s): Phase II; 4. Overall survival; Timepoint(s): Phase II; 5. PFS excluding biochemical (PSA) alone progression; Timepoint(s): Phase II; 6. Progression Free Survival from start of study treatment; Timepoint(s): Phase II ‐ Primary outcome; 7. Safety and tolerability profiles; Timepoint(s): Phase I and II INCLUSION CRITERIA: 1.Histologically or cytologically proven mCRPC with documented metastases (measurable or evaluable disease is acceptable) now eligible for treatment with docetaxel chemotherapy 2.Disease progression since the last change in therapy defined by one or more of the following according to the Prostate Cancer Working Group (PCWG2) criteria (J Clin Oncol 2008¿26:11481159): 2.1. PSA progression as defined by the prostate cancer working group (2) (PCWG2) criteria (Scher et al. 2008 J Clin Oncol. 26¿ 1148). This must be based on a series of at least 3 readings at least 7 days apart. The 3rd reading must be >= 2ng/ml. In the event where an intermediate reading is lower than a previous reading, then the patient will still be eligible (ie. the 3 readings do not need to be consecutive). The first of the three readings must have been obtained after commencing the previous systemic therapy, or, in the case of androgen receptor antagonists, after discontinuing. 2.2. Radiogr