A Study Evaluating the Pain Palliation Benefit of Adding Custirsen to Docetaxel Retreatment or Cabazitaxel as Second Line Therapy in Men With Metastatic Castrate Resistant Prostate Cancer (mCRPC)

1. Age ≥ 18 years on the date of consent.

2. Histological or cytological diagnosis of adenocarcinoma of the prostate.

3. Metastatic disease at screening on a chest, abdomen or pelvic CT or bone scan.

4. Concurrent pain and analgesic use that is viewed by the Investigator to be related to prostate cancer.

5. Received at least 4 cycles of prior docetaxel-based first-line chemotherapy for metastatic disease based on a q3 week schedule of docetaxel. Patients treated on a weekly or alternate schedule for first-line docetaxel must have received an accumulated dose of docetaxel of at least 300 mg/M2.

6. Current progressive disease during or after completing first-line docetaxel treatment.

7. Baseline laboratory values at screening visit within protocol defined limits.

8. Must be willing to continue primary androgen suppression with luteinizing hormone releasing hormone (LHRH) analogues throughout the study, if not treated with bilateral orchiectomy.

9. Adequate bone marrow function.

10. Karnofsky score ≥ 70% at screening visit.

11. At least 21 days have passed since completing radiotherapy at the time of randomization.

12. At least 21 days have passed since completing any cytotoxic agent or investigational agent given in combination with the docetaxel-based first-line therapy, including ASOs (except custirsen which is an exclusion criterion), at the time of randomization.

13. Has recovered from all therapy related toxicity to ≤ grade 2 (except alopecia, anemia and any signs or symptoms of androgen deprivation therapy).

14. Patient can tolerate a starting dose of docetaxel of 75 mg/M2 or cabazitaxel at 25 mg/M2.

15. Patient must have remained on the same bisphosphonate or denosumab usage for a minimum of 12 weeks prior to randomization.

16. Written informed consent must be obtained prior to any protocol-specific procedures being performed.

What this study is about