Real-world use of darolutamide and other ARPIs for men with newly diagnosed metastatic hormone-sensitive prostate cancer
Double-DARE: Analysis of Doublet and Triplet Therapy With Darolutamide and Other Androgen Receptor Pathway Inhibitors in de Novo mHSPC Patients Seen in Urology Clinics in the USA
This study uses electronic medical records to see how darolutamide and other androgen receptor pathway inhibitors are used and what outcomes occur for men newly diagnosed with de novo metastatic hormone-sensitive prostate cancer in US urology clinics.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1400 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Bayer Industry-sponsored |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Cleveland, Ohio) |
| Trial ID | NCT07406282 on ClinicalTrials.gov |
What this trial studies
This observational analysis examines EMR data from US urology clinics to describe prescribing patterns and outcomes for darolutamide and other ARPIs in de novo mHSPC. Eligible patients are adult males who initiated an ARPI within ±90 days of diagnosis and have at least 90 days of EMR activity before and after ARPI start, with ADT and/or docetaxel initiation captured. The study will characterize treatment regimens (doublet versus triplet), treatment sequences, persistence, and recorded clinical outcomes and adverse events as available in the records. Findings are intended to fill gaps in real-world utilization and outcomes to inform clinical decision-making.
Who should consider this trial
Good fit: Ideal candidates are adult men with newly diagnosed (de novo) metastatic hormone-sensitive prostate cancer who started an ARPI within about 90 days of diagnosis and have linked EMR data before and after treatment initiation.
Not a fit: Patients with prior other primary cancers (except non-melanoma skin cancer), prior PARP inhibitor/chemotherapy/immunotherapy/radiopharmaceutical use before ARPI start, evidence of castration-resistant disease, or those enrolled in clinical trials are unlikely to be included or derive direct benefit from this observational analysis.
Why it matters
Potential benefit: If successful, the results could help doctors and patients choose and sequence ARPI regimens by providing real-world evidence about how darolutamide and other ARPIs perform in routine urology practice.
How similar studies have performed: Other real-world EMR studies have described ARPI treatment patterns and outcomes, but darolutamide-specific real-world data for de novo mHSPC remain limited, so this analysis is partly novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male patients with evidence of de novo mHSPC during the study period * Initiation of ARPI therapy during the patient identification period and within ±90 days from the mHSPC diagnosis * Age ≥18 years at index date (ARPI initiation for mHSPC) * Initiation of ADT and/or docetaxel therapy within ±90 days from index date * At least 90 days of EMR activity prior to the index date * At least 90 days of EMR activity post-index, unless the patient died earlier. Exclusion Criteria: * History of other primary cancers (except non-melanoma skin cancer) * Use of PARP inhibitors, chemotherapy (other than docetaxel), immunotherapy or radiopharmaceuticals prior to index date * Evidence of castration resistance (CR) flag in the database any time before the index date or up to 90 days after the de novo mHSPC diagnosis * Clinical trial participation during the study period.
Where this trial is running
Cleveland, Ohio
- Precision Point Specialty LLC PPS Analytics, a Specialty Networks LLC Company — Cleveland, Ohio, United States (Recruiting)
Study contacts
- Study coordinator: Bayer Clinical Trials Contact
- Email: clinical-trials-contact@bayer.com
- Phone: (+)1-888-84 22937
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.