Patient-Reported Outcomes in mCSPC

Exploratory Analysis From the TITAN Study

Patients reported that there was NO NEGATIVE IMPACT to their health-related quality of life (HRQoL) after initiation of treatment with ERLEADA®*†1

Patients reported that there was no negative impact

Analysis of change from baseline in the FACT-P score showed that HRQoL was maintained with ERLEADA® + ADT, with no substantial between-group difference.2

Mean Change From Baseline in FACT-P Total Score1

*The FACT-P patient-reported outcome questionnaire was used to assess prostate cancer symptoms, pain-related symptoms, and overall HRQoL in the TITAN study. The FACT-P is a 39-item questionnaire developed and validated specifically in patients with prostate cancer. The scores for 5 FACT-P subscales (physical well-being, social and family well-being, emotional well-being, functional well-being, and prostate cancer subscale) can be added together to make a single overall score that ranges from 0-156. Higher values of FACT-P total and all subscales indicate a higher HRQoL. In the TITAN study, the FACT-P was completed during Cycles 1 to 7, then every other cycle until the end of treatment, and at months 4, 8, and 12 in follow-up. Each treatment cycle was 28 days.1,3

Study Design: TITAN was a phase 3, multicenter, randomized, double-blind, placebo-controlled trial of patients with mCSPC (N=1052). Patients 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. Patients were randomized 1:1 to receive ERLEADA® 240 mg orally once daily or placebo orally once daily. All patients in the TITAN trial received a concomitant GnRH analog or had a prior bilateral orchiectomy. The dual primary endpoints were overall survival and rPFS. Overall survival was defined as the time from randomization to the date of death from any cause. rPFS was based on investigator assessment and was defined as time from randomization to radiographic disease progression or death. Radiographic disease progression was defined by identification of 2 or more new bone lesions on a bone scan with confirmation (Prostate Cancer Working Group 2 criteria) and/or progression in soft tissue disease.2,4

Learn more about the TITAN study design

HRQoL based on patient-reported outcomes is not reported in the ERLEADA® Prescribing Information. HRQoL should be viewed in the context of patient management and the overall physical condition and clinical course of the patient.

ADT = androgen deprivation therapy; FACT-P = Functional Assessment of Cancer Therapy–Prostate; GnRH = gonadotropin-releasing hormone; mCSPC = metastatic castration-sensitive prostate cancer; rPFS = radiographic progression-free survival; TITAN = Targeted Investigational Treatment Analysis of Novel Antiandrogen.