493
Participants
Start Date
December 13, 2023
Primary Completion Date
July 31, 2030
Study Completion Date
December 31, 2030
Darolutamide
2x300 mg tablets twice daily, for up to 96 weeks
Darolutamide matched placebo
2x300 mg tablets twice daily, for up to 96 weeks
Radiotherapy
Preferred regimens: 60 to 62 Gy delivered in 20 fractions of 3.0 to 3.1Gy per fraction; 36.25 Gy delivered in 5 fractions of 7.25 Gy per fraction, 2-3 fractions per week
Zoladex 3.6Mg Implant
3.6 mg, subcutaneous use
Zoladex LA
10.8 mg, subcutaneous use
Decapeptyl sustained release 22.5 mg
22.5 mg, intramusculair injection
Decapeptyl sustained release 11.25 mg
11.25 mg, intramusculair injection
Depo-Eligard 45 mg
45 mg, subcutaneous use
Depo-Eligard 22.5 mg
22.5 mg, subcutaneous use
Depo-Eligard 7.5 mg
7.5 mg, subcutaneous use
Firmagon 120 MG Injection
120 mg, subcutaneous use
Firmagon 80 MG Injection
80 mg, subcutaneous use
Docetaxel
75 mg per square m, IV infusion
NOT_YET_RECRUITING
AZ Sint-Lucas, Ghent
NOT_YET_RECRUITING
Saint Luc, Brussels
NOT_YET_RECRUITING
UZA, Edegem
RECRUITING
GZA Sint-Augustinus, Wilrijk
NOT_YET_RECRUITING
CHU Liège, Liège
NOT_YET_RECRUITING
AZ Sint-Jan, Bruges
NOT_YET_RECRUITING
AZ Groeninge, Kortrijk
NOT_YET_RECRUITING
AZ Delta, Roeselare
NOT_YET_RECRUITING
UZ Gent, Ghent
NOT_YET_RECRUITING
VITAZ, Sint-Niklaas
NOT_YET_RECRUITING
OLVZ Aalst, Aalst
Collaborators (1)
Bayer
INDUSTRY
Veracyte, Inc.
INDUSTRY
Cancer Research Antwerp
OTHER