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临床试验/CTRI/2024/06/068779
CTRI/2024/06/068779尚未招募不适用

Real-World Treatment Patterns and Clinical Outcomes Among Patients with Metastatic Adenocarcinoma of the Prostate

Pfizer Products India Private Limited8 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2024年6月22日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
300
试验地点
8
主要终点
Describe demographic and clinical characteristics at first diagnosis of metastatic

研究概览

简要总结

Real-World Treatment Patterns and Clinical Outcomes Among Patients with Metastatic Adenocarcinoma of the Prostate.

This is a multicentric, non-interventional, real-world observational study involving the review of pertinent data from medical records.

The study cohort will consist of all patients who meet the eligibility criteria. The date of metastatic prostate cancer diagnosis will define the study index date (T1), which must occur during the case selection window of 01 January 2023 onwards. The selection of these study dates is based on consideration of the anticipated data collection date, the need to document current treatment patterns (from the first-line metastatic setting), and allowance of at least 18-month follow-up opportunity for the assessment of study outcomes, particularly OS.

The time of metastatic prostate cancer diagnosis (T1) will represent the baseline. The baseline characteristics and treatment history prior to T1 will be assessed. The follow-up period will begin on the index date (T1). Patients will be followed until date of death or the date of last recorded medical visit. Patients who died before 18 months of follow-up and patients who have less than 18 months of follow-up as of their last recorded medical visit will be allowed into the study. All patient medical records that occur during follow-up will be reviewed and data on treatment regimens, treatment characteristics, clinical outcomes, and

resource use will be extracted. Consistent with the routine-care of mCSPC and mCRPC patients and differences in healthcare systems across the country (India), the follow-up visits are likely to be different.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
Male

入选标准

  • Patients diagnosed and/or treated with mCSPC or mCRPC 01 January 2023 onwards, inclusive.
  • mCSPC is defined as the current and/or historical presence of metastases on any imaging modality sensitive to hormone therapy.
  • mCRPC is defined as the current and/or historical presence of metastases on any imaging modality with evidence of disease progression (a rising PSA or radiographic progression (as defined by the investigator) despite ongoing castration therapy [ADT or prior surgical orchiectomy]).1,9 Aged at least 18 years upon diagnosis of mCSPC or mCRPC.

排除标准

  • Previously enrolled in an interventional trial related to metastatic prostate cancer.

结局指标

主要结局

Describe demographic and clinical characteristics at first diagnosis of metastatic

时间窗: 18 months

adenocarcinoma of prostate (mCSPC and mCRPC).

时间窗: 18 months

Document treatment patterns from original prostate cancer diagnosis in both mCSPC

时间窗: 18 months

and mCRPC.

时间窗: 18 months

Assess clinical outcomes among patients diagnosed with mCSPC and mCRPC,

时间窗: 18 months

including PSA response and real-world progression-free survival (PFS) in DDR

时间窗: 18 months

mutation/wild type, ORR, and OS.

时间窗: 18 months

Report mCRPC-specific HCRU.

时间窗: 18 months

Document time on treatment for each line of treatment for mCSPC and mCRPC.

时间窗: 18 months

Document time to next treatment from initiation of a systemic therapy line to the

时间窗: 18 months

commencement of the subsequent systemic therapy line for mCSPC and mCRPC.

时间窗: 18 months

Document time to subsequent chemotherapy from initiation of first-line systemic

时间窗: 18 months

treatment for mCSPC and mCSPC.

时间窗: 18 months

次要结局

  • NA(NA)

研究者

发起方
Pfizer Products India Private Limited
申办方类型
Pharmaceutical industry-Global
责任方
Principal Investigator
主要研究者

Dr Antara Chaudhri

Pfizer Products India Private Limited

研究点 (8)

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