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SAKK 08/23: Addition of Darolutamide to first line treatment of mCRPC: a randomized open label phase II trial

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-512132-29-00
Acronym
SAKK 08/23
Enrollment
100
Registered
2025-05-22
Start date
2025-08-06
Completion date
Unknown
Last updated
2025-05-22

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

Conditions

Metastatic castration-resistant prostate cancer

Brief summary

Radiographic progression-free survival.

Detailed description

Overall survival., Time to symptomatic/clinical progression., Time to PSA progression (defined according to PCWG3)., Event-free survival (EFS) – event being defined as one of the following: - death from any cause - presence of radiographic progression and symptomatic/clinical progression; - presence of radiographic progression and PSA progression; - presence of symptomatic/clinical progression and PSA progression, Objective response rate according to RECIST., PSA response (30%, 50%, 90% and best)., Duration of PSA response (50%)., AEs.

Interventions

DRUGCabazitaxel Accord 20 mg/ml concentrate for solution for infusion
DRUGLynparza 150 mg film-coated tablets

Sponsors

Swiss Group for Clinical Cancer Research
Lead SponsorOTHER

Eligibility

Sex/Gender
Male
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Radiographic progression-free survival.

Secondary

MeasureTime frame
Overall survival., Time to symptomatic/clinical progression., Time to PSA progression (defined according to PCWG3)., Event-free survival (EFS) – event being defined as one of the following: - death from any cause - presence of radiographic progression and symptomatic/clinical progression; - presence of radiographic progression and PSA progression; - presence of symptomatic/clinical progression and PSA progression, Objective response rate according to RECIST., PSA response (30%, 50%, 90% and best)., Duration of PSA response (50%)., AEs.

Countries

Spain

Outcome results

None listed

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