Table 1.
Ongoing phase II and phase III trials of novel therapies in mCRPC*
| Agent | Clinicaltrials.gov ID | Randomization | Primary endpoint | Patient population | Trial status (planned accrual) |
| Epithelial | |||||
| Cabazitaxel | NCT00417079 | Cabazitaxel + prednisone vs mitoxantrone + prednisone | OS | Post-docetaxel | Completed (755 patients) |
| OGX-011 (Custirsen) | NCT01188187 | Docetaxel + prednisone + custirsen vs docetaxel + prednisone | OS | Chemo naive | Recruiting (800 patients) |
| NCT01083615 | Custirsen vs placebo | Pain | Post-docetaxel | Recruiting (292 patients) | |
| Stromal | |||||
| Atrasentan | NCT00134056 | Docetaxel + prednisone + atrasentan vs Docetaxel + prednisone | OS and PFS | Chemo naive | Ongoing, not recruiting (930 patients) |
| NCT00036556 | Atrasentan vs placebo | TTP | CRPC, nonmetastatic | Completed (941 patients) | |
| NCT00036543 | Atrasentan vs placebo | TTP | Chemo naive | Completed (1000 patients) | |
| Antiangiogenesis | |||||
| Bevacizumab | NCT00110214 | Docetaxel + prednisone + bevacizumab vs docetaxel + prednisone | OS | Chemo naive | Ongoing, not recruiting (1020 patients) |
| Thalidomide (phase II) | NCT00004635 | Thalidomide vs placebo | TTPF | Androgen dependent | Completed (101 patients) |
| NCT00089609 | Docetaxel + thalidomide + bevacizumab | TTPF immunologic changes | Chemo naive | Ongoing, not recruiting (73 patients) | |
| Sunitinib | NCT00676650 | Sunitinib + prednisone vs prednisone | OS | Post-docetaxel | Expected 873 patients, prematurely discontinued |
| Antiandrogens | |||||
| Abiraterone acetate | NCT00887198 | AA + prednisone vs prednisone | OS and PFS | Chemo naive | Ongoing, not recruiting (1000 patients) |
| NCT00638690 | AA + prednisone vs prednisone | OS | Post-docetaxel | Ongoing, not recruiting (1158 patients) | |
| TAK-700 (phase I/II) (phase III) | NCT00569153 | TAK-700 | RR | Chemo naive | Ongoing, not recruiting (123 patients) |
| NCT01193244 | TAK-700 + prednisone vs prednisone | OS and PFS | Chemo naive | Recruiting (1454 patients) | |
| NCT01193257 | TAK-700 + prednisone vs prednisone | OS and PFS | Post-docetaxel | Recruiting (1083 patients) | |
| MDV3100 | NCT00974311 | MDV3100 vs placebo | OS | Post-docetaxel | Ongoing, not recruiting |
| NCT01212991 | MDV3100 vs placebo | OS and PFS | Chemo naive | Recruiting (1680 patients) | |
| Targeted | |||||
| Dasatinib | NCT00744497 | Docetaxel + prednisone + dasatinib vs docetaxel + prednisone | OS | Chemo naive | Recruiting (1500 patients) |
| Dovitinib (TKI258) (Phase II) | NCT00831792 | Dovitinib | OS and TTPF | CRPC | Ongoing, not recruiting (40 patients) |
| XL-184 (Cabozantinib) (phase II) | NCT00940225 | XL-184 | RR | Solid tumors | Recruiting (1300 patients) |
| Immunotherapy | |||||
| Provenge (Sipuleucel-T) | NCT00779402 | Provenge vs placebo | TTPF | Hormone-sensitive PSA increase | Ongoing, not recruiting (159 patients) |
| NCT01133704 | Provenge vs placebo | TTP | Chemo naive | Completed (98 patients) | |
| NCT00065442 | Provenge vs Placebo | OS | Chemo naive | Completed (512 patients) | |
| NCT00005947 | Provenge vs placebo | TTP | Chemo naive | Completed (127 patients) | |
| PROSTVAC-F/TRICOM | NCT01322490 | PROSTVAC-F/TRICOM ± GM-CSF vs placebo | OS | Chemo naive | Not recruiting (1200 patients) |
| Ipilimumab | NCT00861614 | Ipilimumab vs placebo | OS | Post-docetaxel | Recruiting (800 patients) |
| NCT01057810 | Ipilimumab vs placebo | OS | Chemo naive | Recruiting (600 patients) | |
*
AA = Abiraterone acetate; CRPC = castrate-resistant prostate cancer; GM-CSF = granulocyte-macrophage colony-stimulating factor; OS = overall survival; PFS = progression-free survival; RR = response rate; PSA = prostate-specific antigen; TTP = time to disease progression; TTPF = time to PSA failure.