REal-world EvideNce Study describinG treAtment Intensification Patterns amonG Canadian patiEnts With mHSPC Using EHR Data From Community Urology Clinics
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 700
- 试验地点
- 2
- 主要终点
- Treatment intensification in patients with mHSPC
研究概览
简要总结
This is an observational study in which only data are collected from adult Canadian men with metastatic hormone sensitive prostate cancer (mHSPC) are studied. Participants will not receive any advice on treatment or any changes to the healthcare.
Metastatic hormone sensitive prostate cancer is a cancer of the prostate gland, a male reproductive gland found below the bladder. Metastatic means that cancer has spread to other parts of the body. Hormone-sensitive means it can be treated with anti-hormonal therapy such as androgen deprivation therapy (ADT).
ADT lowers the level of testosterone and slows down the growth of cancer cells. However, in some cases, ADT alone is not sufficient and doctors recommend combining it with treatments like Androgen Receptor Pathway Inhibitors (ARPi) and/or docetaxel to stop the growth of cancer cells.
ARPi slow down the growth of the cancer cells by blocking a sex hormone called the androgens from attaching to the protein found in the cancer cells. ARPi includes medicines like apalutamide, darolutamide, and enzalutamide.
Docetaxel is a medicine used to treat different types of cancer and works by stopping the growth and spread of cancer cells. ADT, ARPi, and docetaxel are approved treatments for men with mHSPC in Canada.
The participants in this study are already receiving treatment for mHSPC as part of their routine medical care from their doctors.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Men aged ≥ 18 years diagnosed with mHSPC verified by radiographic evidence of metastasis with Conventional Imaging (CI) or Prostate Specific Membrane Antigen-Positron Emission Tomography (PSMA-PET), and histologically confirmed carcinoma
- •At least 6 months follow-up post-diagnosis period, unless the patient died earlier
排除标准
- •ADT use for >6 months or any use of ARPi (ADT use in the neoadjuvant or adjuvant setting where the patient has been off treatment for 12 months or more is allowed)
- •This criterion is to ensure that we are capturing mHSPC patients and not Metastatic Castration-Resistant Prostate Cancer (mCRPC) patients who have progressed from earlier stages
- •Evidence of inclusion in clinical trials during the study period
研究组 & 干预措施
Cohort C
Androgen Deprivation Therapy (ADT)+Docetaxel: Patients initiating docetaxel within 180 days of start of ADT after Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) diagnosis
Cohort D
Androgen Deprivation Therapy (ADT)+Androgen Receptor Pathway Inhibitor (ARPi): Patients initiating ARPi within 180 days of start of ADT after mHSPC diagnosis
Cohort A
No Androgen Deprivation Therapy (ADT) nor Androgen Receptor Pathway Inhibitor (ARPi) treatment
Cohort B
Androgen Deprivation Therapy (ADT) Monotherapy: Patients initiating or continuing ADT alone for up to 180 days after Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) diagnosis
Cohort E
Androgen Deprivation Therapy (ADT)+Androgen Receptor Pathway Inhibitor (ARPi)+Docetaxel: Patients initiating ARPi and docetaxel within 180 days start of ADT after Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) diagnosis
结局指标
主要结局
Treatment intensification in patients with mHSPC
时间窗: January 2018 until June 2026
The primary outcome of interest is utilization of treatment intensification in patients with mHSPC, including: Frequencies and percentages of patients in each treatment cohort
次要结局
- Demographics: age in years(January 2018 until June 2026)
- Clinical characteristics: date of diagnosis of prostate cancer(January 2018 until June 2026)
- Clinical characteristics: date of mHSPC diagnosis (as confirmed by radiographic evidence of metastasis with CI or PSMA-PET, and histologically confirmed carcinoma)(January 2018 until June 2026)
- Clinical characteristics: year of mHSPC diagnosis(January 2018 until June 2026)
- Clinical characteristics: Eastern Cooperative Oncology Group (ECOG) score(January 2018 until June 2026)
- Clinical characteristics: Gleason score(January 2018 until June 2026)
- Clinical characteristics: comorbidities (Charlson Comorbidity Index)(January 2018 until June 2026)
- Clinical characteristics: disease volume/risk at baseline(January 2018 until June 2026)
- Clinical characteristics: radiological evidence of metastases (number and site) at time of initial mHSPC diagnosis(January 2018 until June 2026)
- Physician characteristics: practice size(January 2018 until June 2026)
- Physician characteristics: years in practice(January 2018 until June 2026)
- Physician characteristics: number of patients seen annually with prostate cancer(January 2018 until June 2026)
- Physician characteristics: treatment areas of expertise(January 2018 until June 2026)
- Reasons for treatment discontinuation and/or changing treatment by treatment cohort(January 2018 until June 2026)
- Time to treatment discontinuation (TTD)(January 2018 until June 2026)
- mCRPC real-world progression free survival (rwPFS)(January 2018 until June 2026)
- Referral patterns for intensification among patients with mHSPC(January 2018 until June 2026)
- Docetaxel dosage adjustments(January 2018 until June 2026)