(20510) A Phase 4, randomized, open-label, multicenter efficacy and safety study of standard dose of radium-223 dichloride vs. standard doses of novel anti-hormonal therapy (NAH) in patients with bone dominant metastatic castration resistant prostate cancer (mCRPC) progressing on/after one line of NAH

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-505830-89-00

Acronym

20510

Enrollment

514

Registered

2024-02-08

Start date

2020-08-05

Completion date

Unknown

Last updated

2025-10-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

metastatic castrate resistant prostate cancer (mCRPC)

Brief summary

Overall survival (OS)

Detailed description

Time to first symptomatic skeletal event (SSE), Radiological Progression-free survival (rPFS), Time to pain progression (BPI-SF), Adverse events assessments using NCI CTCAE (V5.0), Incidence of fractures, Time to deterioration of FACT-P total score

Interventions

DRUGXtandi - 40 mg soft capsules

DRUGZYTIGA 500 mg film-coated tablets

DRUGXofigo 1100 kBq/mL solution for injection

DRUGDELTACORTENE 5 mg compresse

DRUGPrednisolone 5mg Tablets

Eligibility

Sex/Gender

Male

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Overall survival (OS)	—

Secondary

Measure	Time frame
Time to first symptomatic skeletal event (SSE), Radiological Progression-free survival (rPFS), Time to pain progression (BPI-SF), Adverse events assessments using NCI CTCAE (V5.0), Incidence of fractures, Time to deterioration of FACT-P total score	—

Countries

Austria, Czechia, Finland, France, Germany, Hungary, Italy, Lithuania, Poland, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026