ROAD - Real-World Outcomes of Darolutamide, ADT, With or Without Docetaxel in Metastatic Hormone-Sensitive Prostate Cancer
概览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Bayer
- 入组人数
- 1,600
- 试验地点
- 16
- 主要终点
- Proportion of patients in cohort 1 achieving undetectable PSA (<0.2 ng/mL) at 1 year
概览
简要总结
This is an international, prospective, open-label, multicenter, multi-cohort, non-interventional observational study designed to describe the real-world effectiveness and safety of darolutamide in combination with androgen deprivation therapy (ADT), with or without docetaxel, in patients with metastatic hormone-sensitive prostate cancer (mHSPC). The study aims to enroll approximately 1,600 male patients (800 per cohort) from multiple countries, primarily in Europe, who have a diagnosis of mHSPC and for whom a decision to treat with darolutamide has been made by the treating physician prior to enrollment. The primary objective is to estimate the proportion of patients achieving undetectable prostate-specific antigen (PSA) levels (<0.2 ng/mL) at 1 year of treatment in each cohort. Secondary objectives include describing patient demographics, clinical characteristics, prior and concomitant treatments, adverse events, and clinical effectiveness measures such as overall survival, time to new treatment, time to castration resistance, and time to PSA progression. Further objectives involve assessing quality of life, reasons for not adding docetaxel, outcomes by patient subgroups (e.g., Gleason score, disease volume, ECOG status), genomic testing results, and hospitalization rates. Data will be collected using electronic case report forms (eCRF) during routine clinical practice, with no additional diagnostic or monitoring procedures required beyond standard care. All patients must provide informed consent prior to participation. The study will comply with applicable regulatory requirements, including IEC/IRB approval in all participating countries. Statistical analyses will be descriptive and exploratory, with interim analyses planned after 200, 400, and 600 patients per cohort have completed at least 12 months of treatment or discontinued therapy. The study is expected to provide valuable insights into the real-world use of darolutamide in mHSPC, supporting clinical decision-making and enhancing understanding of treatment patterns, effectiveness, and safety in diverse patient populations.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male patient with a diagnosis of mHSPC
- •Male aged ≥18 years (or country's legal age of adulthood if \>18 years)
- •Histologically or cytologically confirmed adenocarcinoma of prostate; may have begun ADT (up to 120 days prior to enrollment)
- •Metastatic disease by conventional or new generation imaging
- •Decision to initiate treatment with darolutamide with or without docetaxel made prior to enrollment
- •Signed informed patient consent before start of data collection
- •Life expectancy of ≥3 months based on clinical judgment
排除标准
- •Participation in an investigational program with interventions outside of routine clinical practice
- •Contraindications according to local marketing authorization
- •Any prior treatment with second-generation AR inhibitors (enzalutamide, apalutamide, or investigational AR inhibitors), CYP17 inhibitors (abiraterone acetate or investigational CYP17 inhibitors) as antineoplastic treatment for prostate cancer
- •Prior hormone therapy in the metastatic setting
- •Treatment with darolutamide initiated more than 7 days prior to enrollment
研究组 & 干预措施
Darolutamide + ADT + Docetaxel (Triplet therapy)
This group includes men with metastatic hormone-sensitive prostate cancer (mHSPC) who are treated with a combination of darolutamide, androgen deprivation therapy (ADT), and docetaxel. The decision to use this triplet therapy is made by the treating physician as part of routine clinical practice before the patient enrolls in the study. Patients in this cohort receive all three treatments according to local standard of care.
干预措施: Darolutamide (BAY 1841788) (Drug)
Darolutamide + ADT (Doublet therapy)
This group includes men with metastatic hormone-sensitive prostate cancer (mHSPC) who are treated with darolutamide and androgen deprivation therapy (ADT), but without docetaxel. The decision to use this doublet therapy is made by the treating physician as part of routine clinical practice before the patient enrolls in the study. Patients in this cohort receive darolutamide and ADT according to local standard of care.
干预措施: Darolutamide (BAY 1841788) (Drug)
Darolutamide + ADT + Docetaxel (Triplet therapy)
This group includes men with metastatic hormone-sensitive prostate cancer (mHSPC) who are treated with a combination of darolutamide, androgen deprivation therapy (ADT), and docetaxel. The decision to use this triplet therapy is made by the treating physician as part of routine clinical practice before the patient enrolls in the study. Patients in this cohort receive all three treatments according to local standard of care.
干预措施: ADT (Drug)
Darolutamide + ADT + Docetaxel (Triplet therapy)
This group includes men with metastatic hormone-sensitive prostate cancer (mHSPC) who are treated with a combination of darolutamide, androgen deprivation therapy (ADT), and docetaxel. The decision to use this triplet therapy is made by the treating physician as part of routine clinical practice before the patient enrolls in the study. Patients in this cohort receive all three treatments according to local standard of care.
干预措施: Docetaxel (Drug)
Darolutamide + ADT (Doublet therapy)
This group includes men with metastatic hormone-sensitive prostate cancer (mHSPC) who are treated with darolutamide and androgen deprivation therapy (ADT), but without docetaxel. The decision to use this doublet therapy is made by the treating physician as part of routine clinical practice before the patient enrolls in the study. Patients in this cohort receive darolutamide and ADT according to local standard of care.
干预措施: ADT (Drug)
结局指标
主要结局
Proportion of patients in cohort 1 achieving undetectable PSA (<0.2 ng/mL) at 1 year
时间窗: after 1 year of treatment
To describe the effectiveness of darolutamide + ADT + docetaxel in patients with mHSPC by means of estimating the prostate-specific antigen (PSA) undetectable rates (PSA\<0.2 ng/mL) after 1 year of study treatment.
Proportion of patients in cohort 2 achieving undetectable PSA (<0.2 ng/mL) at 1 year
时间窗: after 1 year of treatment
To describe the effectiveness of darolutamide + ADT in patients with mHSPC by means of estimating the prostate-specific antigen (PSA) undetectable rates (PSA\<0.2 ng/mL) after 1 year of study treatment.
次要结局
- Overall survival per cohort and per country(up to 4 years)
- Overall survival per cohort in all countries(up to 4 years)
- Time to subsequent treatment per cohort and per country(up to 4 years)
- Time to subsequent treatment per cohort in all countries(up to 4 years)
- Time to castration resistance (CRPC) per cohort and per country(up to 4 years)
- Time to castration resistance (CRPC) per cohort in all countries(up to 4 years)
- Time to PSA progression per cohort and per country(up to 4 years)
- Survival rate per cohort and per country(up to 4 years)
- Time to PSA progression per cohort in all countries(up to 4 years)
- PSA response rate per cohort and per country(1 year)
- PSA response rate per cohort in all countries(1 year)
- Survival rate per cohort and all countries(up to 4 years)
- Time to discontinuation per cohort and per country(up to 4 years)
- Time to discontinuation per cohort in all countries(up to 4 years)
- Reason for discontinuation percohort and per country(up to 4 years)
- Reason for discontinuation per cohort in all countries(up to 4 years)
- Patient demographics per cohort and per country(at baseline)
- Patient demographics per cohort in all countries(at baseline)
- Medical History per cohort and per country(at baseline)
- Medical History per cohort in all countries(at baseline)
- Concomitant medication per cohort and per country(up to 4 years)
- Concomitant medication per cohort in all countries(up to 4 years)
- Concomitant treatment per cohort and per country(up to 4 years)
- Concomitant treatment per cohort in all countries(up to 4 years)
- Darolutamide use per cohort and per country(up to 4 years)
- Darolutamide use per cohort in all countries(up to 4 years)
- Diagnostic Imaging Technology per cohort and per country(at baseline)
- Diagnostic Imaging Technology per cohort in all countries(at baseline)
- Adverse events per cohort and per country(up to 4 years)
- Adverse events per cohort in all countries(up to 4 years)
- Serious Adverse events per cohort and per country(up to 4 years)
- Serious Adverse events per cohort in all countries(up to 4 years)
- Drug-related Adverse events per cohort and per country(up to 4 years)
- Drug-related Adverse events per cohort in all countries(up to 4 years)
- Serious Drug-related Adverse events per cohort and per country(up to 4 years)
- Serious Drug-related Adverse events per cohort in all countries(up to 4 years)
- Adverse events leading to treatment discontinuation per cohort and per country(up to 4 years)
- Adverse events leading to treatment discontinuation per cohort in all countries(up to 4 years)
- Vital Signs: Blood Pressure per cohort and per country(up to 4 years)
- Vital Signs: Blood Pressure per cohort in all countries(up to 4 years)
- Vital Signs: Body Temperature per cohort and per country(up to 4 years)
- Vital Signs: Body Temperature per cohort in all countries(up to 4 years)
- Vital Signs: Weight per cohort and per country(up to 4 years)
- Vital Signs: Weight per cohort in all countries(up to 4 years)
- Vital Signs: Height per cohort and per country(up to 4 years)
- Vital Signs: Height per cohort in all countries(up to 4 years)
- Laboratory Parameters: Hematology (Hemoglobin) per cohort and per country(up to 4 years)
- Laboratory Parameters: Hematology (Hemoglobin) per cohort in all countries(up to 4 years)
- Laboratory Parameters: Hematology (WBC) per cohort and per country(up to 4 years)
- Laboratory Parameters: Hematology (WBC) per cohort in all countries(up to 4 years)
- Laboratory Parameters: Hematology (Platelet Count) per cohort and per country(up to 4 years)
- Laboratory Parameters: Hematology (Platelet Count) per cohort in all countries(up to 4 years)
- Laboratory Parameters: Clinical Chemistry (Creatinine) per cohort and per country(up to 4 years)
- Laboratory Parameters: Clinical Chemistry (Creatinine) per cohort in all countries(up to 4 years)
- Laboratory Parameters: Clinical Chemistry (ALT) per cohort and per country(up to 4 years)
- Laboratory Parameters: Clinical Chemistry (ALT) per cohort in all countries(up to 4 years)
- Laboratory Parameters: Clinical Chemistry (AST) per cohort and per country(up to 4 years)
- Laboratory Parameters: Clinical Chemistry (AST) per cohort in all countries(up to 4 years)
- Laboratory Parameters: Clinical Chemistry (Bilirubin) per cohort and per country(up to 4 years)
- Laboratory Parameters: Clinical Chemistry (Bilirubin) per cohort in all countries(up to 4 years)
- Laboratory Parameters: Clinical Chemistry (Alkaline Phosphatase) per cohort and per country(up to 4 years)
- Laboratory Parameters: Clinical Chemistry (Alkaline Phosphatase) per cohort in all countries(up to 4 years)
- Laboratory Parameters: Clinical Chemistry (PSA) per cohort and per country(up to 4 years)
- Laboratory Parameters: Clinical Chemistry (PSA) per cohort in all countries(up to 4 years)