TrialSignal
Clinical trial intelligence report
A Randomized Phase 3 Study Comparing Cabazitaxel/Prednisone in Combination With Custirsen (OGX-011) to Cabazitaxel/Prednisone for Second-Line Chemotherapy in Men With Metastatic Castrate Resistant Prostate Cancer (AFFINITY)
Source-linked diligence brief with registry provenance, taxonomy normalization and premium analytical context.
Generated
Jun 20, 2026
NCT ID
NCT01578655
Status
COMPLETED
Phase
PHASE3
Sponsor
Achieve Life Sciences
Executive brief
Investment-Ready Snapshot
This Phase 3 study has been designed to confirm that adding custirsen to cabazitaxel/prednisone treatment can slow tumor progression and enhance survival outcomes compared to standard cabazitaxel/prednisone treatment in men with metastatic castrate resistant prostate cancer (CRPC). This will be a randomized, open-label, multicenter, international trial. Treatment will consist of cabazitaxel/prednisone/custirsen vs. cabazitaxel/prednisone. A total of approximately 630 patients will be randomized with equal probability to the two arms.
Source & freshness
Provenance
https://clinicaltrials.gov/study/NCT01578655
Indication
Prostate Cancer
Modality
small molecule
Target
cabazitaxel, prednisone, custirsen sodium
Intervention
cabazitaxel, prednisone, custirsen sodium
Source record
Protocol Description
Detailed source ingestion pending.
Source record
Outcome Measures
Detailed source ingestion pending.
Source record
Eligibility
Detailed source ingestion pending.
AI analysis
Known Results And Readout Context
Detailed source ingestion pending.
IP intelligence
Patent And IP Landscape
Detailed source ingestion pending.
Source record
Contacts
Detailed source ingestion pending.