Localised prostate cancer at high risk of recurrence
Conditions
Brief summary
Metastasis-free survival (metastasis or death from any cause, MFS)
Detailed description
Overall survival (death from any cause, OS), Prostate cancer specific survival (death from prostate cancer), PSA progression-free survival (Phoenix criteria, or death from any cause, PSA-PFS), Clinical progression-free survival (imaging, symptoms, signs, initiation of other anti-cancer treatment, or death from any cause, clinical-PFS), Time to subsequent hormonal therapy (restarting ADT), Time to castration-resistant disease (PCWG2 criteria), Safety (adverse events - CTCAE v4.03), Health related quality of life (EORTC QLQC-30 & PR-25, EQ-5D-5L), Health outcomes relative to costs (incremental cost effectiveness ration)
Interventions
DRUGANANDRON 150 mg
DRUGcomprimé
Sponsors
Cancer Trials Ireland
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Metastasis-free survival (metastasis or death from any cause, MFS) | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival (death from any cause, OS), Prostate cancer specific survival (death from prostate cancer), PSA progression-free survival (Phoenix criteria, or death from any cause, PSA-PFS), Clinical progression-free survival (imaging, symptoms, signs, initiation of other anti-cancer treatment, or death from any cause, clinical-PFS), Time to subsequent hormonal therapy (restarting ADT), Time to castration-resistant disease (PCWG2 criteria), Safety (adverse events - CTCAE v4.03), Health related quality of life (EORTC QLQC-30 & PR-25, EQ-5D-5L), Health outcomes relative to costs (incremental cost effectiveness ration) | — |
Countries
Austria, Ireland, Spain
Outcome results
None listed