Recruiting

Darolutamide

Sponsor:

Bayer

Code:

NCT07406282

Conditions

Prostatic Neoplasms

Metastatic Hormone-Sensitive Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Darolutamide

Abiraterone acetate

Enzalutamide

Apalutamide

Study Details

Brief summary:

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.

Conditions

Prostatic Neoplasms

Metastatic Hormone-Sensitive Prostate Cancer

Study ID

NCT07406282

Start date

Jul 22, 2025

Status verified date

Jul, 2026

Completion date

Sep 30, 2026

Anticipated

Primary completion date

Sep 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

1400 participants

Anticipated

Interventions and Outcome Measures

Arms

Darolutamide + ADT + docetaxel

Patients receiving darolutamide in combination with androgen deprivation therapy with docetaxel

Abiraterone acetate + ADT + docetaxel

Patients receiving abiraterone acetate in combination with androgen deprivation therapy with docetaxel

Enzalutamide + ADT

Patients receiving enzalutamide in combination with androgen deprivation therapy

Apalutamide + ADT

Patients receiving apalutamide in combination with androgen deprivation therapy

Darolutamide + ADT

Patients receiving darolutamide in combination with androgen deprivation therapy

Abiraterone acetate + ADT

Patients receiving abiraterone acetate in combination with androgen deprivation therapy

Interventions

Darolutamide

Androgen receptor pathway inhibitor for treatment of metastatic hormone-sensitive prostate cancer

Abiraterone acetate

Androgen receptor pathway inhibitor for treatment of metastatic hormone-sensitive prostate cancer

Enzalutamide

Androgen receptor pathway inhibitor for treatment of metastatic hormone-sensitive prostate cancer

Apalutamide

Androgen receptor pathway inhibitor for treatment of metastatic hormone-sensitive prostate cancer

Primary outcome measure

  • Describe baseline demographic of de novo mHSPC patients receiving darolutamide + ADT + docetaxel (triplet therapy): age [ Time Frame: Baseline ]
  • Describe baseline demographic of de novo mHSPC patients receiving darolutamide + ADT (doublet therapy): age [ Time Frame: Baseline ]
  • Describe baseline clinical characteristics of de novo mHSPC patients receiving darolutamide + ADT + docetaxel (triplet therapy): Concomitant Medication [ Time Frame: Baseline ]
  • Describe baseline clinical characteristics of de novo mHSPC patients receiving darolutamide + ADT (doublet therapy): Concomitant Medication [ Time Frame: Baseline ]
  • Describe baseline demographic of de novo mHSPC patients receiving darolutamide + ADT + docetaxel (triplet therapy): ethnicity [ Time Frame: Baseline ]
  • Describe baseline demographic of de novo mHSPC patients receiving darolutamide + ADT (doublet therapy): ethnicity [ Time Frame: Baseline ]
  • Describe baseline clinical characteristics of de novo mHSPC patients receiving darolutamide + ADT + docetaxel (triplet therapy): Charlson Comorbidity Index [ Time Frame: Baseline ]
  • Describe baseline clinical characteristics of de novo mHSPC patients receiving darolutamide + ADT (doublet therapy): Charlson Comorbidity Index [ Time Frame: Baseline ]
  • Describe baseline clinical characteristics of de novo mHSPC patients receiving darolutamide + ADT + docetaxel (triplet therapy): Gleason Score [ Time Frame: Baseline ]
  • Describe baseline clinical characteristics of de novo mHSPC patients receiving darolutamide + ADT (doublet therapy): Gleason Score [ Time Frame: Baseline ]
  • Describe baseline clinical characteristics of de novo mHSPC patients receiving darolutamide + ADT + docetaxel (triplet therapy): PSA [ Time Frame: Baseline ]
  • Describe baseline clinical characteristics of de novo mHSPC patients receiving darolutamide + ADT (doublet therapy): PSA [ Time Frame: Baseline ]
  • Describe baseline clinical characteristics of de novo mHSPC patients receiving darolutamide + ADT + docetaxel (triplet therapy): de novo mHSPC Diagnosis [ Time Frame: Baseline ]
  • Describe baseline clinical characteristics of de novo mHSPC patients receiving darolutamide + ADT (doublet therapy): de novo mHSPC Diagnosis [ Time Frame: Baseline ]
  • Describe drug utilization patterns of de novo mHSPC patients receiving darolutamide + ADT + docetaxel (triplet therapy) during the study period: initial dose [ Time Frame: Day 1 - recorded on the index date (date of first evidence of darolutamide initiation/prescription). ]
  • Describe drug utilization patterns of de novo mHSPC patients receiving darolutamide + ADT (doublet therapy) during the study period: initial dose [ Time Frame: Day 1 - recorded on the index date (date of first evidence of darolutamide initiation/prescription). ]
  • Describe drug utilization patterns of de novo mHSPC patients receiving darolutamide + ADT + docetaxel (triplet therapy) during the study period: dose change [ Time Frame: From index date (Day 1) until the date of the first documented darolutamide dose modification, assessed up to 39 months. ]
  • Describe drug utilization patterns of de novo mHSPC patients receiving darolutamide + ADT (doublet therapy) during the study period: dose change [ Time Frame: From index date (Day 1) until the date of the first documented darolutamide dose modification, assessed up to 39 months. ]
  • Describe drug utilization patterns of de novo mHSPC patients receiving darolutamide + ADT + docetaxel (triplet therapy) during the study period: treatment interruption [ Time Frame: From index date (Day 1) until the date of the first documented darolutamide interruption, assessed up to 39 months. ]
  • Describe drug utilization patterns of de novo mHSPC patients receiving darolutamide + ADT (doublet therapy) during the study period: treatment interruption [ Time Frame: From index date (Day 1) until the date of the first documented darolutamide interruption, assessed up to 39 months. ]
  • Describe drug utilization patterns of de novo mHSPC patients receiving darolutamide + ADT + docetaxel (triplet therapy) during the study period: treatment discontinuation [ Time Frame: From index date until permanent darolutamide discontinuation, assessed up to 39 months. ]
  • Describe drug utilization patterns of de novo mHSPC patients receiving darolutamide + ADT (doublet therapy) during the study period: treatment discontinuation [ Time Frame: From index date until permanent darolutamide discontinuation, assessed up to 39 months. ]
  • Describe drug utilization patterns of de novo mHSPC patients receiving darolutamide + ADT + docetaxel (triplet therapy) during the study period:switch to another Androgen receptor pathway inhibitor (ARPI) [ Time Frame: From the index date until the date of new ARPI initiation, assessed up to 39 months. ]
  • Describe drug utilization patterns of de novo mHSPC patients receiving darolutamide + ADT (doublet therapy) during the study period:switch to another Androgen receptor pathway inhibitor (ARPI) [ Time Frame: From the index date until the date of new ARPI initiation, assessed up to 39 months. ]
  • Describe drug utilization patterns of de novo mHSPC patients receiving darolutamide + ADT + docetaxel (triplet therapy) during the study period:number of docetaxel cycles (if information is available) [ Time Frame: Date of first docetaxel infusion that occurs within ±90 days of index through the last documented docetaxel infusion ]
  • Describe treatment outcomes of de novo mHSPC patients receiving darolutamide + ADT + docetaxel (triplet therapy) during the study period: adverse events [ Time Frame: From index date (Day 1) through 30 days after recorded end-of-darolutamide treatment ]
  • Describe treatment outcomes of de novo mHSPC patients receiving darolutamide + ADT (doublet therapy) during the study period: adverse events [ Time Frame: From index date (Day 1) through 30 days after recorded end-of-darolutamide treatment ]
  • Describe treatment outcomes of de novo mHSPC patients receiving darolutamide + ADT + docetaxel (triplet therapy) during the study period: comorbid conditions not recorded at baseline [ Time Frame: From index date (Day 1) through recorded end of darolutamide treatment, up to 39 months. ]
  • Describe treatment outcomes of de novo mHSPC patients receiving darolutamide + ADT (doublet therapy) during the study period:comorbid conditions not recorded at baseline [ Time Frame: From index date (Day 1) through recorded end of darolutamide treatment, up to 39 months. ]
  • Describe treatment outcomes of de novo mHSPC patients receiving darolutamide + ADT + docetaxel (triplet therapy) during the study period: PSA response ≥90% [ Time Frame: Evaluated at 3, 6, and 12 months from the index treatment. ]
  • Describe treatment outcomes of de novo mHSPC patients receiving darolutamide + ADT (doublet therapy) during the study period:PSA response ≥90% [ Time Frame: Evaluated at 3, 6, and 12 months from the index treatment. ]
  • Describe treatment outcomes of de novo mHSPC patients receiving darolutamide + ADT + docetaxel (triplet therapy) during the study period: PSA decline to <0.2 ng/mL (undetectable) [ Time Frame: Evaluated at 3, 6, and 12 months from the index treatment. ]
  • Describe treatment outcomes of de novo mHSPC patients receiving darolutamide + ADT (doublet therapy) during the study period: PSA decline to <0.2 ng/mL (undetectable) [ Time Frame: Evaluated at 3, 6, and 12 months from the index treatment. ]
  • Describe treatment outcomes of de novo mHSPC patients receiving darolutamide + ADT + docetaxel (triplet therapy) during the study period: initiation of next antineoplastic therapy [ Time Frame: From index date (Day 1) until initiation of next antineoplastic therapy, assessed up to 39 months. ]
  • Describe treatment outcomes of de novo mHSPC patients receiving darolutamide + ADT (doublet therapy) during the study period: initiation of next antineoplastic therapy [ Time Frame: From index date (Day 1) until initiation of next antineoplastic therapy, assessed up to 39 months. ]
  • Describe treatment outcomes of de novo mHSPC patients receiving darolutamide + ADT + docetaxel (triplet therapy) during the study period: radiographic progression to mCRPC [ Time Frame: From index date (Day 1) until radiographic progression to mCRPC, assessed up to 39 months. ]
  • Describe treatment outcomes of de novo mHSPC patients receiving darolutamide + ADT (doublet therapy) during the study period: radiographic progression to mCRPC [ Time Frame: From index date (Day 1) until radiographic progression to mCRPC, assessed up to 39 months. ]
  • Describe treatment outcomes of de novo mHSPC patients receiving darolutamide + ADT + docetaxel (triplet therapy) during the study period: all-cause mortality [ Time Frame: From index date (Day 1) until death from any cause, assessed up to 39 months. ]
  • Describe treatment outcomes of de novo mHSPC patients receiving darolutamide + ADT (doublet therapy) during the study period: all-cause mortality [ Time Frame: From index date (Day 1) until death from any cause, assessed up to 39 months. ]

Central Contacts and Locations

Central contacts

Bayer Clinical Trials Contact

(+)1-888-84 22937clinical-trials-contact@bayer.com

Locations

Precision Point Specialty LLC PPS Analytics, a Specialty Networks LLC Company

Recruiting

Cleveland, Ohio, United States, 44114-2619

More Information

Sponsor

Bayer

Last update posted

Jul 7, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Bayer on 2026-07-07.