Prostate-cancer Treatment Using Stereotactic Radiotherapy for Oligometastases Ablation in Hormone-sensitive Patients

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

550

Participants

Timeline

Start Date

June 23, 2020

Primary Completion Date

June 23, 2026

Study Completion Date

February 28, 2031

Conditions
Oligometastatic Hormone Sensitive Prostate Cancer
Interventions
RADIATION

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."

DRUG

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)."

Trial Locations (35)

13009

Institut Paoli Calmettes, Marseille

14000

Centre François Baclesse, Caen

26000

Centre de radiothérapie Marie Curie de Valence, Valence

29200

Centre d'oncologie - Clinique Pasteur, Brest

CHRU de Brest, Brest

31059

IUCT- Oncopole -Institut Claudius Regaud, Toulouse

31076

Clinique PASTEUR, Toulouse

33076

Institut Bergonié, Bordeaux

35042

Centre Eugene Marquis, Rennes

35760

CHP Saint Grégoire, Saint-Grégoire

42055

Institut de cancérologie et d'hématologie universitaire de Saint Etienne, Saint-Etienne

44277

Hôpital Privé du Confluent, Nantes

44805

ICO René Gauducheau, Nantes

51100

Institut du Cancer Courlancy, Reims

56000

Groupe Hospitalier Bretagne Sud, Lorient

59020

Centre Oscar Lambret, Lille

60100

Centre Amethyst de Creil, Creil

63000

Centre Jean Perrin, Clermont-Ferrand

67065

Institut de cancérologie Strasbourg Europe (ICANS ), Strasbourg

69008

Centre Leon Berard, Lyon

69495

CHU Lyon Sud, Pierre-Bénite

74374

CH Annecy, Pringy

75005

Institut Curie, Paris

76031

CHU de Rouen - Charles Nicole, Rouen

76038

Centre Henri Becquerel, Rouen

77650

Institut de cancérologie de Seine et Marne - Clinique de Jossiny, Jossigny

78000

Centre Amethyst - Oncologie 78, Versailles

80005

Institut Sainte Catherine, Avignon

94000

Centre Hospitalier Intercommunal de Créteil, Créteil

94160

HIA Begin, Saint-Mandé

94805

Gustave Roussy Cancer Campus Grand Paris, Villejuif

95200

Institut de Cancerologie Paris Nord, Sarcelles

97261

CHU Martinique, Fort-de-France

06250

Centre Azureen de Cancerologie, Mougins

06189

Centre Antoine Lacassagne, Nice

All Listed Sponsors
lead

UNICANCER

OTHER

NCT04115007 - Prostate-cancer Treatment Using Stereotactic Radiotherapy for Oligometastases Ablation in Hormone-sensitive Patients | Biotech Hunter | Biotech Hunter