490
Participants
Start Date
January 9, 2020
Primary Completion Date
September 28, 2028
Study Completion Date
December 28, 2033
Apalutamide
"240 mg PO daily should start the same day as the first LHRHa administration for 6 months.~months."
Salvage radiotherapy (SRT)
"The SRT treatment will be administered to a total dose of 66 Gy (in 33 fractions of 2 Gy) directed at the prostate bed with an additional 56.1 Gy (in 33 fractions of 1.7 Gy) directed at the pelvis region. The pelvis will be irradiated in all patients.~An additional simultaneously integrated boost of 69.3 Gy (in 33 fractions of 2.1 Gy) can be delivered to a local relapse based on Positron Emission Tomography - Computed Tomography (PET/CT) and Magnetic Resonance Imaging (MRI) images."
Luteinising Hormone Releasing Hormone agonist (LHRHa)
Doses of LHRHa may vary due to availability of different brand names and pharmaceutical forms. It will be left to the discretion of the investigator.
Clinique Claude Bernard, Albi
Institut de Cancérologie de l'Ouest, Angers
Institut Bergonié, Bordeau
Centre Georges François LECLERC, Dijon
Centre Hospitalier Emile ROUX, Le Puy-en-Velay
Centre Oscar Lambret, Lille
Institut de Cancérologie de Montpellier, Montpellier
Centre Antoine Lacassagne, Nice
Institut Jean Godinot, Reims
Centre Henri Becquerel, Rouen
Institut de Cancérologie de l'Ouest, Saint-Herblain
Institut de Cancérologie de la Loire Lucien Neuwirth, Saint-Priest-en-Jarez
Institut de Cancérologie Paris Nord, Sarcelles
Centre Paul STRAUSS, Strasbourg
Clinique Pasteur - ONCORAD, Toulouse
Collaborators (1)
Janssen Pharmaceutica
INDUSTRY
UNICANCER
OTHER