Safety in mCSPC

Established safety profile1

Adverse reactions (all grades) with ≥10% incidence in the ERLEADA® + ADT arm that occurred with at least 2% greater frequency than in the placebo + ADT arm in the TITAN study1

Adverse Reactions ERLEADA® + ADT
Placebo + ADT
Rash 28% 9%
Hot flush 23% 16%
Hypertension 18% 16%
Arthralgia 17% 15%
Pruritus 11% 5%

Grades 3 and 4 adverse reactions in the TITAN study1

Adverse Reactions ERLEADA® + ADT
Placebo + ADT
Hypertension 8% 9%
Rash 6% 0.6%
Pruritus <1% <1%
Arthralgia 0.4% 0.9%
Hot flush 0% 0%

Serious adverse reactions occurred in 20% of patients in the ERLEADA® + ADT arm and 20% of patients in the placebo + ADT arm.1

The discontinuation rate due to adverse reactions was 8% in the ERLEADA® + ADT arm.1

In the combined data of 2 randomized, placebo-controlled clinical studies, rash associated with ERLEADA® was most commonly described as macular or maculopapular. The onset of rash occurred at a median of 83 days of ERLEADA® treatment. Rash resolved in 78% of patients within a median of 78 days from onset of rash.1

Consistent safety profile after long-term follow-up

After nearly 4 years of median follow-up, the safety profile of ERLEADA® was consistent with the initial analysis of the TITAN study.2

ERLEADA® is the AR inhibitor with the longest follow-up reported in registration trials of mCSPC2,3

  • 44 months of median follow-up in TITAN*2

*TITAN final analysis data are not currently reported in the ERLEADA® Prescribing Information.

ADT = androgen deprivation therapy; mCSPC = metastatic castration-sensitive prostate cancer; TITAN = Targeted Investigational Treatment Analysis of Novel Antiandrogen.


1. ERLEADA® [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc.

2. Chi KN, Chowdhury S, Bjartell A, et al. Apalutamide in patients with metastatic castration-sensitive prostate cancer: final survival analysis of the randomized, double-blind, phase III TITAN study [published online April 29, 2021]. J Clin Oncol.

3. Armstrong AJ, Szmulewitz RZ, Petrylak DP, et al. ARCHES: a randomized, phase III study of androgen deprivation therapy with enzalutamide or placebo in men with metastatic hormone-sensitive prostate cancer. J Clin Oncol. 2019;37(32):2974-2986.