ProfesseurEtude randomisée comparant l'irradiation accompagnée d'une déprivation androgénique adjuvante de long terme avec l'antagoniste GnRH versus déprivation androgénique avec l'agoniste GnRH plus une protection de l'effet flare dans des patients avec haut risque de cancer de la prostate localisé ou localement avancé.
Indication
Cancer de la prostate localisé ou localement avancé
Phase IIIb
Status : ouverte à l'inclusion
Sponsor
EORTC
Investigateur
Dr Thomas Zilli -
Service de radio-oncologie HUG
Avenue de la Roseraie 53
1205 Genève
Tél. +4122 37 27 132
Objectives
The primary objective of the trial is to assess if GnRH antagonists in combination with external beam radiation therapy improve progression free survival (progression thaht can be biological, clinical, or death) compared to GnRH agonists in combination with external beam radiation therapy. Secondary objectives include:
- documentation of effect of GnRH antagonists on clinically significant cardiovascular events in the subgroup of patients at high risk of such events at abseline;
- documentation of side effects and quality of life, I-PSS and urinary tract infections;
- assessment of relative treatment effect on secondary efficacy endpoints (clinical progression, time to next line of systemic therapy, time on therapy, overall and cancer specific survival) and PSA at 6 months after end of RT).
