Study: NCT06282588

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Darolutamide
Description: 2x300 mg tablets twice daily, for up to 96 weeks

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Darolutamide
Description: 2x300 mg tablets twice daily, for up to 96 weeks

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Darolutamide matched placebo
Description: 2x300 mg tablets twice daily, for up to 96 weeks

Intervention type: RADIATION
Group type: EXPERIMENTAL
Intervention: Radiotherapy
Description: 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

Intervention type: RADIATION
Group type: PLACEBO_COMPARATOR
Intervention: Radiotherapy
Description: 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

Intervention type: RADIATION
Group type: EXPERIMENTAL
Intervention: Radiotherapy
Description: 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

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Zoladex 3.6Mg Implant
Description: 3.6 mg, subcutaneous use

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Zoladex 3.6Mg Implant
Description: 3.6 mg, subcutaneous use

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Zoladex LA
Description: 10.8 mg, subcutaneous use

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Zoladex LA
Description: 10.8 mg, subcutaneous use

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Decapeptyl sustained release 22.5 mg
Description: 22.5 mg, intramusculair injection

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Decapeptyl sustained release 22.5 mg
Description: 22.5 mg, intramusculair injection

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Decapeptyl sustained release 11.25 mg
Description: 11.25 mg, intramusculair injection

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Decapeptyl sustained release 11.25 mg
Description: 11.25 mg, intramusculair injection

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Depo-Eligard 45 mg
Description: 45 mg, subcutaneous use

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Depo-Eligard 45 mg
Description: 45 mg, subcutaneous use

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Depo-Eligard 22.5 mg
Description: 22.5 mg, subcutaneous use

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Depo-Eligard 22.5 mg
Description: 22.5 mg, subcutaneous use

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Depo-Eligard 7.5 mg
Description: 7.5 mg, subcutaneous use

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Depo-Eligard 7.5 mg
Description: 7.5 mg, subcutaneous use

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Firmagon 120 MG Injection
Description: 120 mg, subcutaneous use

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Firmagon 120 MG Injection
Description: 120 mg, subcutaneous use

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Firmagon 80 MG Injection
Description: 80 mg, subcutaneous use