Darolutamide Combination Therapy Efficacy and Safety in Advanced Prostate Cancer

A systematic review and meta-analysis of 3 randomized clinical trials involving 3,483 patients with advanced prostate cancer, published up to January 15, 2026. The dataset, authored by Xi Cao and shared under a CC-BY-4.0 license, aggregates results from the ARAMIS, ARASENS, and ARANOTE trials to evaluate overall survival, metastasis-free survival, and adverse events for darolutamide combination therapies.

Use Cases

• Compare overall survival (OS) outcomes between darolutamide and placebo groups based on aggregated trial data.
• Analyze metastasis-free survival (MFS) in non-metastatic castration-resistant prostate cancer (nmCRPC) patients.
• Assess the safety profile of darolutamide by evaluating rates of overall adverse events, grade ≥3 adverse events, and serious adverse events.
• Perform subgroup meta-analyses for mHSPC patients based on baseline total PSA (tPSA) values and Gleason scores.
• Validate the risk of bias in randomized controlled trials using the Cochrane RoB 2 tool methodology described.

Strengths

• Aggregates data from 3 distinct randomized clinical trials (ARAMIS, ARASENS, ARANOTE).
• Includes results for 3,483 patients, with specific counts for 1,509 nmCRPC and 1,974 mHSPC patients.
• Systematic review protocol is registered with identifier CRD420251145736, enhancing reproducibility.

Limitations

• Column-level documentation is absent; field semantics must be inferred after download.
• Row count is unknown, which may limit suitability assessment.
• The dataset is a 287.3 KB PDF file, suggesting the primary data is embedded in a document format rather than a structured table.

Provenance

Source

Aggregated from PubMed, EMBASE, Web of Science, ClinicalTrials.gov, and the Cochrane Library.

Collection Method

Systematic review and meta-analysis of randomized controlled trials.

Time Range

From database inception to January 15, 2026.

Freshness

Last updated 2026-05-18 05:37:52; freshness should be verified.