| ADT = androgen deprivation therapy; ECOG = Eastern Cooperative Oncology Group; FU = follow-up; HR = hazard ratio; ISUP = International Society for Urological Pathology; mo = month; n = number of patients; OS = overall survival; P = prednisone; PSA-DT = prostate-specific antigen-doubling time. | ||||||
| STAMPEDE «James ND, Sydes MR, Clarke NW ym. Addition of doce...»1, «Clarke NW, Ali A, Ingleby FC ym. Addition of docet...»2 | GETUG «Gravis G, Fizazi K, Joly F ym. Androgen-deprivatio...»3 | CHAARTED «Sweeney CJ, Chen YH, Carducci M ym. Chemohormonal ...»4, «Kyriakopoulos CE, Chen YH, Carducci MA ym. Chemoho...»5 | ||||
|---|---|---|---|---|---|---|
| ADT | ADT + Docetaxel + P | ADT | ADT + Docetaxel | ADT | ADT + Docetaxel | |
| N | 1,184 | 592 | 193 | 192 | 393 | 397 |
| Newly diagnosed M+ |
58% | 59% | 75% | 67% | 73% | 73% |
| Key inclusion Criteria |
Patients scheduled for long-term ADT newly diagnosed M1 or N+ situations locally advanced (at least two of cT3 cT4, ISUP grade ≥ 4, PSA ≥ 40 ng/mL) relapsing locally treated disease with a PSA > 4 ng/mL and a PSA-DT < 6 mo. or PSA > 20 ng/mL, or nodal or metastatic relapse |
Metastatic disease Karnofsky score ≥ 70% |
Metastatic disease ECOG PS 0, 1 or 2 |
|||
| Primary objective |
OS | OS | OS | |||
| Median follow up (mo) |
43; 78.2 (update M1) | 50 | 54 (update) | |||
| HR (95% CI) | 0.78 (0.66–0.93) | 1.01 (0.75–1.36) | 0.72 (0.59–0.89) | |||
| M1 only | ||||||
| N | 1,086 | - | - | |||
| HR (95% CI) | 0.81 (0.69–0.95) | - | - | |||