What is the TITAN study?[1][2]
Broad patient population[1][2]
Key eligibility criteria[2]
- Castration-sensitive
- Distant metastatic disease
(≥1 lesion on bone scan) - ECOG PS 0 or 1
Permitted[2]
- Prior docetaxel
- ADT ≤6 months for mHSPC or ≤3 years for local disease
- Local treatment completed ≥1 year prior
Stratifications[2]
- Gleason score at diagnosis (≤7 or >7)
- Region (NA and EU vs. all other countries)
- Prior docetaxel (yes vs. no)
- Newly diagnosed M1 or M1 following prior treatment
On-study requirement[2]
- Continuous ADT
Study design[1][2]
.svg "TITAN study design")
Adapted from Chi KN, et al. 2021 & Chi KN, et al. 2019.
Dual primary endpoints[1]
- rPFS
- OS
Secondary endpoints[1]
- Time to initiation of cytotoxic chemotherapy
- Time to pain progression
- Time to chronic opioid use
- Time to skeletal-related event
Other clinically relevant endpoints[1]
- Time to symptomatic local progression
- Time to PSA progressiona
- PFS2
aBased on Prostate Cancer Clinical Trials Working Group 2 criteria.[1]
Click below to find out more about the clinical benefits with ERLEADA® + ADT:
Treat early with ERLEADA® + ADT to delay progression and extend life for your mHSPC patients vs. placebo + ADT[1]
Give patients with mHSPC the opportunity for an additional treatment option upon disease progression[1][2]
Push back on progression and maintain QoL in mHSPC[1]
Abbreviations
ADT, androgen deprivation therapy. ECOG, Eastern Cooperative Oncology Group. EU, European Union. M1, metastasised outside the pelvis. mHSPC, metastatic hormone-sensitive prostate cancer. NA, North America. OS, overall survival. PFS2, second progression-free survival. PS, performance status. PSA, prostate-specific antigen. QD, once-daily. rPFS, radiographic progression-free survival. Rx, prescription.
Titular da Autorização de Introdução no Mercado: Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse, Bélgica.
Para mais informações deverá contactar o Representante do Titular da Autorização de Introdução no Mercado: Janssen-Cilag Farmacêutica, Lda.
Medicamento de receita médica restrita, de utilização reservada a certos meios especializados.
Antes de prescrever consulte o RCM completo.
RCM de Erleada®, veja aqui
