550
Participants
Start Date
June 23, 2020
Primary Completion Date
June 23, 2026
Study Completion Date
February 28, 2031
Stereotactic Body Radiotherapy (SBRT) + Standard of care
"Definition of standard of care (prior to randomization):~* Radiotherapy to the prostate in de novo metastatic patients~* Radiotherapy to the pelvic lymph nodes in patients with positive pelvic nodes (given as full dose to the positive lymph node and prophylactic dose to the pelvic nodal basin)~* Long term ADT +/- intermittent treatment~* Additional therapy following tumor board meeting : new generation hormonal therapy (abiraterone, enzalutamide, apalutamide or other approved) or chemotherapy (docetaxel).~SBRT is delivered using the following regimen: 30 Grays (10 Gy x 3 fractions) for axial and appendicular bones and lymph node metastases if present. In case the dose cannot be safely delivered while maintaining a safe dose to the organs at risk, an alternate regimen (35 Gy in 5 fractions of 7 Gy) can be used."
Standard of care
"Definition of standard of care (prior to randomization):~* Radiotherapy to the prostate in de novo metastatic patients~* Radiotherapy to the pelvic lymph nodes in patients with positive pelvic nodes (given as full dose to the positive lymph node and prophylactic dose to the pelvic nodal basin)~* Long term ADT +/- intermittent treatment~* Additional therapy following tumor board meeting : new generation hormonal therapy (abiraterone, enzalutamide, apalutamide or other approved) or chemotherapy (docetaxel)."
Institut Paoli Calmettes, Marseille
Centre François Baclesse, Caen
Centre de radiothérapie Marie Curie de Valence, Valence
Centre d'oncologie - Clinique Pasteur, Brest
CHRU de Brest, Brest
IUCT- Oncopole -Institut Claudius Regaud, Toulouse
Clinique PASTEUR, Toulouse
Institut Bergonié, Bordeaux
Centre Eugene Marquis, Rennes
CHP Saint Grégoire, Saint-Grégoire
Institut de cancérologie et d'hématologie universitaire de Saint Etienne, Saint-Etienne
Hôpital Privé du Confluent, Nantes
ICO René Gauducheau, Nantes
Institut du Cancer Courlancy, Reims
Groupe Hospitalier Bretagne Sud, Lorient
Centre Oscar Lambret, Lille
Centre Amethyst de Creil, Creil
Centre Jean Perrin, Clermont-Ferrand
Institut de cancérologie Strasbourg Europe (ICANS ), Strasbourg
Centre Leon Berard, Lyon
CHU Lyon Sud, Pierre-Bénite
CH Annecy, Pringy
Institut Curie, Paris
CHU de Rouen - Charles Nicole, Rouen
Centre Henri Becquerel, Rouen
Institut de cancérologie de Seine et Marne - Clinique de Jossiny, Jossigny
Centre Amethyst - Oncologie 78, Versailles
Institut Sainte Catherine, Avignon
Centre Hospitalier Intercommunal de Créteil, Créteil
HIA Begin, Saint-Mandé
Gustave Roussy Cancer Campus Grand Paris, Villejuif
Institut de Cancerologie Paris Nord, Sarcelles
CHU Martinique, Fort-de-France
Centre Azureen de Cancerologie, Mougins
Centre Antoine Lacassagne, Nice
UNICANCER
OTHER