Retrospective, Noninterventional Study Assessing the Real-Life Use of The Long-Acting 6-Month Triptorelin Formulation as A Treatment for Different Stages of Prostate Cancer in Italy - REAL6T
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Ipsen
- 入组人数
- 167
- 试验地点
- 13
- 主要终点
- Demographic Characteristic: Body Mass Index (BMI)
研究概览
简要总结
The participants of this study had Prostate Cancer. Prostate cancer is cancer that occurs in the prostate, a small gland in the male reproductive system. This study will collect data on the use of the 6-month triptorelin formulation (Decapeptyl®) in local routine clinical practice as a treatment for different stages of prostate cancer. The aim of this study will be to describe participant characteristics, as well as disease and treatment characteristics before the first injection with the 6-month triptorelin formulation in Italy. The decision to prescribe this product and all hospital visits, dose adjustments, assessments and procedures were made according to routine clinical practice at the time and independently of the decision to enroll the participants in this data collection study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Demographic Characteristic: Body Mass Index (BMI)
时间窗: Before first Injection (before day 1)
BMI of study participants will be reported.
Prostate Cancer-specific Antigen(PSA) Levels
时间窗: Before first Injection (before day 1)
Tumor Characteristics as Evaluated by Eastern Cooperative Oncology Group (ECOG) Score
时间窗: Before first Injection (before day 1)
Tumor characteristics, collected by ECOG Score at the nearest visit just before the injection.
Percentage of Participants Naive to Androgen Deprivation Therapy (ADT), Non-naive to ADT and Castrated
时间窗: Before first Injection (before day 1)
Demographic Characteristic: Age of Participants
时间窗: Before first Injection (before day 1)
The age of study participants will be reported.
Testosterone Levels
时间窗: Before first Injection (before day 1)
Participants serum testosterone levels will be assessed.
Tumor Characteristics as Evaluated by Tumor Node Metastasis (TNM) Staging System
时间窗: Before first Injection (before day 1)
Tumor characteristics, collected by TNM staging system at the nearest visit just before the injection.
Tumor Characteristics as Evaluated by Grade Group and/or Gleason Score
时间窗: Before first Injection (before day 1)
Tumor characteristics, collected by Grade Group and/or Gleason Score at the nearest visit just before the injection.
Describe Data of Participants with Prostate Cancer History
时间窗: Before first Injection (before day 1)
Describe Data including primary treatment or active surveillance, and other therapies.
次要结局
- Percentage of Participants With Triptorelin-related Adverse events (AEs), Serious Adverse Events (SAEs), Non-SAEs and as well as Special Situations AEs(From first injection (at day 1) with the 6-month formulation up to 6 months after the last injection with this product.)
- Reasons for Choosing the 6-month Triptorelin Formulation(From first injection (Day 1) with the 6-month formulation up to 6 months after the last injection with this product)
- Prostate Cancer-specific Antigen (PSA) Levels(At first injection (Day 1) with the 6-month triptorelin formulation up to the 6 months after the last injection with this product)
- Percentage of Participants who Switched to 6-month Triptorelin Formulation From the 3-Month Triptorelin Formulation or Another LHRH Analogue(At first injection (Day 1) with the 6-month triptorelin formulation up to the 6 months after the last injection with this product)
- Percentage of Participants Using Prostate Cancer-related Concomitant Therapies(From first injection (Day 1) with the 6-month formulation up to 6 months after the last injection with this product)
- Percentage of Participants who Either Permanently or Temporarily Discontinued 6-month Triptorelin Formulation(From first injection (Day 1) with the 6-month formulation up to 6 months after the last injection with this product)
- Percentage of Participants who Switched to the 3-month triptorelin Formulation or Another Luteinizing Hormone-releasing Hormone (LHRH) Analogue from 6-month formulation(At first injection (Day 1) with the 6-month triptorelin formulation up to the 6 months after the last injection with this product)
- Percentage of Participants Whose Serum Testosterone Levels Never Reached Castration Levels(During treatment with the 6-month formulation (approximatively three years of existing participants data).)
- Duration of Treatment with 6-month Triptorelin Formulation(From first injection (Day 1) with the 6-month formulation up to 6 months after the last injection with this product)
- Percentage of Participants whose Serum Testosterone Levels Presented Castration Levels (testosterone levels <50 nanograms per deciliter)(From first injection (Day 1) with the 6-month formulation up to 6 months after the last injection with this product)
- Potential Factors Predictive of any Treatment Switch(At first injection (Day 1) with the 6-month triptorelin formulation up to the 6 months after the last injection with this product)
- Percentage of Participants who Were Noncastrated or Castration-naïve and who Presented Serum Testosterone Levels Corresponding to Castration(Day 45 up to 6 months after the last injection with this product)