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NCT01578655COMPLETEDanonymous

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)

Sponsor

Source record

Achieve Life Sciences

Phase

Source record

PHASE3

Modality

AI-normalized

small molecule

Target

AI-normalized

cabazitaxel, prednisone, custirsen sodium

Indication / condition

AI-normalized

Prostate Cancer

Intervention

Source record

cabazitaxel, prednisone, custirsen sodium

Source & freshness

Source record

NCT ID

NCT01578655

Original source

ClinicalTrials.gov

Source last updated

Oct 12, 2016

Ingested at

Jun 11, 2026

Internal sync

Jun 11, 2026

Model version

trialsignal-ai-v1

Normalized confidence

96%

Validation status

validated

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View original source fields

NCT ID

NCT01578655

Title

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)

Sponsor

Achieve Life Sciences

Status

COMPLETED

Phase

PHASE3

Condition raw

Prostate Cancer

Condition normalized

Prostate Cancer

Modality raw

small molecule

Modality normalized

small molecule

Target raw

cabazitaxel, prednisone, custirsen sodium

Target normalized

cabazitaxel, prednisone, custirsen sodium

Interventions

cabazitaxel, prednisone, custirsen sodium

Public preview

Source record

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.

AI-generated analysis supports research triage only. Verify source records, publications, sponsor disclosures and IP databases before making diligence decisions. Model: trialsignal-ai-v1.

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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 13, 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

SourceClinicalTrials.gov
Source updatedOct 12, 2016
Internal syncJun 11, 2026
Model versiontrialsignal-ai-v1

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.