Open Label Prostate Cancer Study

Inclusion Criteria

• •Males aged 20 years or older.
• •Histologically or Cytologically proven diagnosis of prostate cancer for which no standard therapy is currently considered appropriate.
• •Documented evidence of metastatic prostate cancer
• •Presence of progressive disease defined as one or more:
• •Biochemical progression of the prostate cancer
• •Progression as defined by Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 guidelines
• •Two or more new metastatic bone lesions from bone scans from a previous assessment
• •Serum testosterone concentration less or equals 50 ng/dL
• •World Health Organization (WHO) performance status 0 to 1 with no deterioration over the previous 2 weeks and minimum life expectancy of 12 weeks.
• •Sexually active males should be willing to use condoms
• •For inclusion in the AZD3514 administered in combination with abiraterone acetate cohort(s), patients must:
• •Have received prior chemotherapy containing or based on docetaxel
• •Not have received prior treatment with abiraterone acetate, MDV3100, TAK700, TOK001 or other similar therapies which target the AR axis or with selective AR down-regulator-like properties
• •For inclusion in the AZD3514 administered in combination with abiraterone acetate in patients who are currently receiving abiraterone acetate cohort(s), patients must:
• a) Have been stable on abiraterone acetate abiraterone acetate for ≥ 4 months (i.e. stable PSA values) and have achieved ≥ 50% reduction in PSA while being treated with abiraterone acetate
• b) Have evidence of biochemical progression (PSA) of the prostate cancer, as defined in inclusion number 5 (except for the withdrawal of abiraterone acetate as an anti-androgen therapy)
• •For inclusion in the paired (same lesion) tumour biopsy research, patients must:
• a) Provide informed consent for paired tumour biopsy sampling
• b) Have bone or soft tissue lesions that are suitable for paired biopsy
• sampling