Table 1.
Recently completed phase 3 trials of ARAT in the hormone-sensitive and nmCRPC settings
| Trial | Patient population | Treatment arms | Outcomes |
|---|---|---|---|
| Hormone-sensitive | |||
| CHAARTED [17] (for comparison) | mHSPC (high volume [visceral metastases or ≥ 4 bone lesions with ≥>1 beyond the vertebral bodies and pelvis] vs. low volume). | • ADT (n = 393) • ADT plus docetaxel (n = 397) |
• Significant improvement in OS with the addition of chemotherapy of 57.6 vs 44months with HR of 0.61 and p < 0.001 |
| LATITUDE [20] | High-risk mHSPC (2/3 criteria: Gleason score of ≥8), at least three bone lesions, and the presence of measurable visceral metastasis) | • ADT (n = 602) • ADT plus abiraterone (n = 597) |
• Significant improvement in OS with the addition of abiraterone to ADT (NR vs. 34.7 mo; HR 0.62; 95% CI 0.51–0.76; p <0.001). |
| STAMPEDE G [21] | nmHSPC (high-risk locally advanced with 2/3 features: i)T3 or T4, ii) Gleason score of ≥8 iii) a PSA level ≥ 40 ng/ml and high-risk relapsed with i)PSA ≥4 ng/ml with PSADT<6 months or ii) PSA ≥ 20 ng/ml) and mHSPC | • ADT (n = 957) • ADT plus abiraterone (n = 960) |
• Significant improvement in three-year OS with the addition of abiraterone to ADT (83 vs. 76%; HR 0.63; 95% CI 0.52–0.76; p <0.001). • OS significantly improved in the mHSPC but not in the nmHSPC patients |
| Nonmetastatic CRPC | |||
| PROSPER [2] | nmCRPC (PSADT<10 months) | • ADT(n = 468) • ADT plus enzalutamide(n =933) |
• Median MFS improved 36.6 months vs 14.7 months with HR of 0.29, p <0.0001 • Median PFS 33.3 months versus 3.9 months |
| SPARTAN [3] | nmCRPC (PSADT<10 months) | • ADT(n =401) • ADT plus apalutamide (n = 806) |
• Median MFS improved 40.5 vs. 16.2 months, respectively, with HR of 0.28 and p <0.001 • Median PFS 40.5 vs. 14.7 months |
| STRIVE [26] | mCRPC and nmCRPC | • ADT plus bicalutamide in nmCRPC (n = 69) • ADT plus enzalutamide in nmCRPC (n =70) |
• Median PFS and median time to PSA progression were not reached with enzalutamide and were 8.6 months and 11.1 months with bicalutamide, respectively, in nmCRPC patients • p < 0.001 for both endpoints, • HR = 0.24 for PFS and 0.19 for PSA progression |
ADT, androgen deprivation therapy; ARAT, androgen-receptor-axis targeted therapy; mHSPC, metastatic hormone sensitive prostate cancer; nmCRPC, nonmetastatic castration resistant prostate cancer