Etude ONE SHOT

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Adresse

Rue Gabrielle Perret-Gentil 4
1205 Genève
Suisse

Professeur
Enrico Tessitore
Directeur Centre des cancers
Professeur
Nicolas Mach
Directeur adjoint Centre des cancers

Etude multicentrique pour évaluer une seule radiothérapie pour les cancers de la prostate localisés.

Indication 

Cancer de la prostate localisé 

Phase I/II

Status : ouverte à l'inclusion

Sponsor
Pr Raymon Miralbell

Investigateur
Dr Thomas Zilli -
Service de radio-oncologie HUG
Avenue de la Roseraie 53
1205 Genève
Tél. +4122 37 27 132

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Objectives 

The main objectives of this phase I/II trial is to determine the safety and efficacy of a
single fraction SBRT at a dose of 19 Gy in patients with localized prostate cancer.

Primary endpoint (phase I)
- Safety will be evaluated using Grade ≥ 3 genitourinary and/or gastrointestinal acute
adverse event (AE) during the first 3 month according to CTCAE classification v.4.03
Primary endpoint (phase II)
- Efficacy will be evaluated using biochemical relapse-free survival (bRFS) at 3-years.
Secondary endpoints (phase II)
- Acute AE (during the first 3 months) according to CTCAE v4.03
- Late AE (after 3 months) according to CTCAE v4.03
- Progression free survival (PFS)
- Clinical progression free survival
- Local progression free survival
- Time to further anti-cancer therapy
- Prostate cancer-specific survival (PCSS)
- Overall survival (OS)
- Quality of life (QoL) evaluated using EPIC 26, IPSS, IIEF-5

 

 

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Dernière mise à jour : 29/01/2019