TITAN Study Design

TITAN: A phase 3, multicenter, randomized, double-blind, placebo-controlled trial of ERLEADA® + ADT vs placebo + ADT in patients with diverse clinical characteristics1,2

Patients in TITAN had newly diagnosed mCSPC or relapsed metastatic disease after an initial diagnosis of localized disease. Patients with visceral (ie, liver or lung) metastases as the only sites of metastases were excluded.2

 

Selected baseline patient characteristics1,2

Median age 68 years (range: 43 to 94 years)
Prior prostatectomy or radiation therapy of the prostate, or both 16%
Prior docetaxel* 11%
Gleason score at diagnosis ≥8 67%
Volume of disease  
High-volume disease 63%
Low-volume disease 37%
Visceral metastasis 12%

*Patients who received prior docetaxel must have met the following criteria: (1) received a maximum of 6 cycles of docetaxel therapy for mCSPC; (2) received the last dose of docetaxel ≤2 months prior to randomization; (3) maintained a response to docetaxel of stable disease or better prior to randomization.2

High volume of disease was defined as metastases involving the viscera with 1 bone lesion or the presence of 4 or more bone lesions, at least 1 of which must be in a bony structure beyond the vertebral column and pelvic bones.1

 

Dual primary endpoints in TITAN2

  • Overall survival
  • Radiographic progression-free survival (rPFS)

Selected secondary endpoint in TITAN2

  • Time to cytotoxic chemotherapy

Selected exploratory endpoint in TITAN2,3

  • Health-related quality of life based on patient-reported outcomes (FACT-P and EQ-5D-5L)

ADT = androgen deprivation therapy; EQ-5D-5L = EuroQol 5-dimension, 5-level questionnaire; FACT-P = Functional Assessment of Cancer Therapy–Prostate; GnRH = gonadotropin-releasing hormone; mCSPC = metastatic castration-sensitive prostate cancer; TITAN = Targeted Investigational Treatment Analysis of Novel Antiandrogen.

References

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

2. Chi KN, Agarwal N, Bjartell A, et al; for the TITAN Investigators. Apalutamide for metastatic, castration-sensitive prostate cancer. N Engl J Med. 2019;381(1):13-24.

3. Agarwal N, McQuarrie K, Bjartell A, et al; TITAN Investigators. Health-related quality of life after apalutamide treatment in patients with metastatic castration-sensitive prostate cancer (TITAN): a randomised, placebo-controlled, phase 3 study. Lancet Oncol. 2019;20(11):1518-1530.