The European Multicentric
Study Phase III-IV is still ongoing for long-term patients follow-up.
Recruitment was completed in October 2000, with n=652 patients included.
Interim analysis was performed on patients treated up to November
1999.
France
Independent ongoing clinical trial sponsored
by the French Urology Association (AFU) in patients with localised
prostate cancer treated with Ablatherm as primary care.
The aim of this study is to confirm the results
observed in the European Multicentric study, to verify that the
therapy may be efficiently used by any urologists, and to collect
economics data. Sample size: n=100. Study start date: Feb. 2001.
Completion of the patient recruitment on January 2002: 115 patients
included + 2 years for the "last patient last visit".
In total, 10 sites are involved (9 using a mobile machine, and 2
using a fixed machine).
Study co-ordinator
and investigational site:
Pr. Richard, Dr. Pierre Conort, Hôpital La Pitié-Salpetrière,
Paris.
Other investigational
sites :
Pr. Vallancien, Paris
Dr. Gelet, Lyon
Pr. Jaqmin, Dr. Saussine, Strasbourg
Pr. Rischmann, Toulouse
Pr. Coulange, Marseille
Pr. Buzelin, Nantes
Pr. Bensadoun, Caen
Pr. Grise, Pr. Pfister, Rouen
Pr. Amiel, Dr. Chevallier, Nice