Etude ONE SHOT

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

Consulter le protocole de l'étude >>

 

Consulter une publication sur l'étude >>

 

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