Table A1.
Indications and Regulatory Labels for the Currently Approved Drugs for CRPC, Aligned With the PCWG3 Manifestation-Specific Outcome Framework
| Early manifestations (response): control, relieve, or eliminate |
| Approved to control pain or indicated for patients with symptoms |
| Mitoxantrone plus prednisone for the treatment of patients with pain related to advanced hormone-refractory prostate cancer |
| 89Sr for the relief of bone pain in patients with painful skeletal metastases |
| 153Sm for relief of pain in patients with osteoblastic metastatic bone lesions that enhance on radionuclide bone scan |
| Radium-223* (symptoms from bone metastases with no involvement of other organs) |
| No FDA drug approvals on the basis of: |
| PSA declines |
| Tumor shrinkage |
| Bone scan improvement |
| Changes in circulating tumor cell number |
| Later manifestations (progression): delay or prevent |
| Approved or shown to delay SREs or SSEs |
| Zoledronic acid (SRE) |
| Denosumab (SRE) |
| Abiraterone acetate (SRE)*,† |
| Enzalutamide (SRE)*,† |
| Radium-223 (SSE)*,‡ |
| Approved for delay of death (survival) |
| Docetaxel |
| Sipuleucel-T |
| Cabazitaxel |
| Abiraterone acetate plus prednisone |
| Enzalutamide |
| Radium-223 |
| Delay of radiographic progression using PCWG2-based criteria, coprimary with survival |
| Abiraterone acetate plus prednisone |
| Enzalutamide |
Abbreviations: CRPC, castration-resistant prostate cancer; FDA, United States Food & Drug Administration; PCWG2, Prostate Cancer Clinical Trials Working Group 2; PCWG3, Prostate Cancer Clinical Trials Working Group 3; PSA, prostate-specific antigen; SREs, skeletal-related events; SSEs, symptomatic skeletal events.
*
Indicated for patients with symptoms.
†
Shown to delay SREs.
‡
Shown to delay SSEs.