Table 1 Effect of apalutamide treatment on PSA kinetics by age in TITAN (N = 1052) and SPARTAN (N = 1207) intent-to-treat populations.

From: Apalutamide efficacy, safety and wellbeing in older patients with advanced prostate cancer from Phase 3 randomised clinical studies TITAN and SPARTAN

 

TITAN (mCSPC)

SPARTAN (nmCRPC)

<65 yr (n = 331)

65–79 yr (n = 628)

≥80 yr (n = 93)

<65 yr (n = 149)

65–79 yr (n = 741)

≥80 yr (n = 317)

APA (n = 149)

PBO (n = 182)

APA (n = 324)

PBO (n = 304)

APA (n = 52)

PBO (n = 41)

APA (n = 106)

PBO (n = 43)

APA (n = 492)

PBO (n = 249)

APA (n = 208)

PBO (n = 109)

PSA nadira

 Median (range), ng/ml

0.04b (0–133)

0.93c (0–408)

0.02d (0–498)

0.68e (0–1408)

0.04 (0–83.7)

0.73 (0–1180)

0.20 (0–48.9)

7.11 (1.5–67.2)

0.32f (0–32.2)

7.18g (0.3–146)

0.75h (0–150)

9.0i (1.0–292)

 Median time (range), mo

5.6 (0.1–40.6)

2.8 (0.7–50.6)

5.6 (0.1–47.9)

4.7 (0.8–50.0)

6.4 (1.0–36.8)

3.7 (0.7–40.4)

8.7 (0.9–29.5)

1.0 (0.9–35.7)

7.4f (0.9–44.2)

1.0g (0.2–24.4)

6.5h (0.7–29.4)

1.0i (0.8–8.3)

Confirmed PSA decline ≥50% from baselinej

 n (%)

132 (89)

86 (47)

292 (90)

180 (59)

49 (94)

24 (59)

98 (93)

1 (2.3)

451 (92)

5 (2.0)

175 (84)

3 (2.8)

 Median timek (range), mo

0.95 (0.9–8.3)

0.97 (0.1–30.7)

0.95 (0.3–11.1)

0.99 (0.1–35.4)

0.95 (0.9–9.2)

1.4 (0.9–23.5)

0.95 (0.7–5.2)

20.3 (20.3–20.3)

0.95 (0.5–10.2)

1.9 (1.0–11.2)

0.95 (0.3–6.5)

1.9 (1.8–4.6)

Confirmed PSA decline to ≤0.2 ng/mlj

 n (%)

90 (60)

52 (29)

231 (71)

101 (33)

35 (67)

13 (32)

51 (48)

0

197 (40)

0

55 (26)

0

 Median timel (range), mo

1.9 (0.9–29.4)

1.0 (0.8–39.6)

1.9 (0.1–33.2)

2.8 (0.7–42.0)

1.9 (0.9–25.8)

4.7 (0.9–33.1)

2.8 (0.9–14.9)

NA

2.8 (0.9–25.8)

NA

2.8 (0.3–22.1)

NA

  1. APA apalutamide, mCSPC metastatic castration-sensitive prostate cancer, nmCRPC non-metastatic castration-resistant prostate cancer, PBO placebo, PSA prostate-specific antigen, NA not available due to lack of response.
  2. aPatients with available PSA data are included.
  3. bn = 148.
  4. cn = 181.
  5. dn = 321.
  6. en = 303.
  7. fn = 488.
  8. gn = 246.
  9. hn = 205.
  10. In = 106.
  11. jConfirmed by a subsequent measurement ≥4 weeks later.
  12. kAssessed in patients with achieved ≥50% PSA decline from baseline.
  13. lAssessed in patients with achieved PSA decline to ≤0.2 ng/ml.
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