Treatment of High-Risk Prostate Cancer Guided by Novel Diagnostic Radio- and Molecular Tracers

PHASE2/PHASE3RecruitingINTERVENTIONAL
Enrollment

493

Participants

Timeline

Start Date

December 13, 2023

Primary Completion Date

July 31, 2030

Study Completion Date

December 31, 2030

Conditions
Prostate Cancer
Interventions
DRUG

Darolutamide

2x300 mg tablets twice daily, for up to 96 weeks

DRUG

Darolutamide matched placebo

2x300 mg tablets twice daily, for up to 96 weeks

RADIATION

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

DRUG

Zoladex 3.6Mg Implant

3.6 mg, subcutaneous use

DRUG

Zoladex LA

10.8 mg, subcutaneous use

DRUG

Decapeptyl sustained release 22.5 mg

22.5 mg, intramusculair injection

DRUG

Decapeptyl sustained release 11.25 mg

11.25 mg, intramusculair injection

DRUG

Depo-Eligard 45 mg

45 mg, subcutaneous use

DRUG

Depo-Eligard 22.5 mg

22.5 mg, subcutaneous use

DRUG

Depo-Eligard 7.5 mg

7.5 mg, subcutaneous use

DRUG

Firmagon 120 MG Injection

120 mg, subcutaneous use

DRUG

Firmagon 80 MG Injection

80 mg, subcutaneous use

DRUG

Docetaxel

75 mg per square m, IV infusion

Trial Locations (11)

900

NOT_YET_RECRUITING

AZ Sint-Lucas, Ghent

1200

NOT_YET_RECRUITING

Saint Luc, Brussels

2600

NOT_YET_RECRUITING

UZA, Edegem

2610

RECRUITING

GZA Sint-Augustinus, Wilrijk

4000

NOT_YET_RECRUITING

CHU Liège, Liège

8000

NOT_YET_RECRUITING

AZ Sint-Jan, Bruges

8500

NOT_YET_RECRUITING

AZ Groeninge, Kortrijk

8800

NOT_YET_RECRUITING

AZ Delta, Roeselare

9000

NOT_YET_RECRUITING

UZ Gent, Ghent

9100

NOT_YET_RECRUITING

VITAZ, Sint-Niklaas

9300

NOT_YET_RECRUITING

OLVZ Aalst, Aalst

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Bayer

INDUSTRY

collaborator

Veracyte, Inc.

INDUSTRY

lead

Cancer Research Antwerp

OTHER

NCT06282588 - Treatment of High-Risk Prostate Cancer Guided by Novel Diagnostic Radio- and Molecular Tracers | Biotech Hunter | Biotech Hunter