As there is no prospective data on the combination of abiraterone and salvage radiotherapy, the aim of this study is to further evaluate the safety profile of abiraterone acetate plus prednisone in patients with prostate cancer who are biochemically relapsing after surgery and undergo salvage radiotherapy with 6-months LH-RH agonist. The investigators hypothesize that the toxicity profile of both treatments should not potentiate each other. This study will also provide preliminary data on the efficacy of this combination.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
47
Abiraterone acetate 1000mg/day + prednisone alone for one month before initiating the sequence of radiotherapy
Institut Bergonié
Bordeaux, France
Centre François Baclesse
Caen, France
Centre Georges François Leclerc
Dijon, France
Centre Leon Berard
Lyon, France
Institut de Cancérologie de l'ouest/René Gauducheau
Saint-Herblain, France
to determine the maximum tolerated dose and the phase II recommended dose of abiraterone acetate treatment plus prednisone and LH-RH agonist combined with prostate radiotherapy
Time frame: within 11 weeks after Radiotherapy initiation
To evaluate the 3-year biochemical relapse-free survival
Time frame: 3 years
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