A Study to Learn About Real-world Utilization and Outcomes of Darolutamide and Other Androgen Receptor Pathway Inhibitors (ARPIs) for Newly Diagnosed Metastatic Hormone-sensitive Prostate Cancer (de Novo mHSPC) in US Urology Clinics
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
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study uses past medical records from US urology clinics to learn how darolutamide and similar drugs are used and how patients do. It looks at adult men whose prostate cancer had spread when first diagnosed and still responded to treatment that lowers male hormones.
Prostate cancer is the most common non-skin cancer among men in the United States. For some men, the cancer has already spread to other parts of the body at the time of diagnosis; this is called metastatic hormone-sensitive prostate cancer (mHSPC). Treatment for mHSPC has advanced significantly, with new standards of care involving androgen deprivation therapy (ADT) combined with drugs known as androgen receptor pathway inhibitors (ARPIs), sometimes alongside chemotherapy like docetaxel. Darolutamide is an ARPI that is approved by the FDA for treating mHSPC in a "triplet" combination with ADT and docetaxel. It is also used in a "doublet" combination with ADT alone. However, there is limited information on how darolutamide is used in real-world clinical settings for this condition, which creates a gap in knowledge for making treatment decisions. This study aims to fill that gap by analyzing real-world data from electronic medical records. The primary goal is to describe the characteristics of patients with newly diagnosed mHSPC who are treated with darolutamide (either as a doublet or triplet) in urology clinics across the US. The study will also examine drug use patterns and clinical outcomes for these patients. Additionally, the study will explore the characteristics of patients treated with other ARPIs (abiraterone acetate, enzalutamide, and apalutamide) and assess the feasibility of creating matched patient groups for future comparative research. Data will be collected retrospectively from a large network of community urology practices in the US.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Men with newly diagnosed prostate cancer that had already spread and still responded to hormone-lowering treatment during the study period.
- Started an androgen receptor pathway inhibitor (ARPI), a drug that blocks male hormone signals, during the required study window and within 90 days before or after diagnosis.
- Were at least 18 years old when they started the ARPI.
- Started hormone-lowering treatment, docetaxel chemotherapy, or both within 90 days before or after starting the ARPI.
- Had electronic medical record activity for at least 90 days before starting the ARPI.
- Had electronic medical record activity for at least 90 days after starting the ARPI, unless they died sooner.
Who can't join
- Had another cancer, except non-melanoma skin cancer.
- Before starting the ARPI, used PARP inhibitors (drugs that block cancer cell repair), chemotherapy other than docetaxel, immune-based cancer treatment, or radioactive cancer drugs.
- Had a record showing the cancer resisted hormone-lowering treatment before starting the ARPI or within 90 days after diagnosis.
- Took part in a clinical trial during the study period.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility 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.
Study sites (1)
OH
- Precision Point Specialty LLC PPS Analytics, a Specialty Networks LLC Company · Cleveland, OH 44114-2619More trials in Cleveland