A Post-Marketing Observational Study to Document Treatment Patterns and to Evaluate Leuprolide and Alternative Therapeutic Approaches to the Treatment of Advanced Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Abbott
- 入组人数
- 2,717
- 试验地点
- 135
- 主要终点
- Effectiveness Parameter for Screening or Recurrence of Prostate Cancer: Mean Prostate-specific Antigen (PSA) at Each Visit
研究概览
简要总结
Document treatment patterns and evaluate LUCRIN / LUCRIN-TRIDEPOT® (Leuprolide) and alternative therapeutic approaches to the treatment of advanced prostate cancer during normal clinical practice and in accordance with the terms of the Belgian marketing authorization and reimbursement conditions.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Patients with advanced prostate cancer who have been prescribed Lucrin/ Lucrin-Tri-depot or any other treatment with local reimbursement guidelines; Patients willing to consent to data being collected and provided to Abbott Laboratories.
排除标准
- •Contraindications according to the Summary of Product Characteristics (SPC).
研究组 & 干预措施
Advanced prostate cancer participants
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment within local reimbursement guidelines.
干预措施: leuprolide (Lucrin/Lucrin-Tri-depot) (Drug)
结局指标
主要结局
Effectiveness Parameter for Screening or Recurrence of Prostate Cancer: Mean Prostate-specific Antigen (PSA) at Each Visit
时间窗: time 0 (Baseline), month 3, and every 3 months until disease progression or up to 24 months, whichever came first
The mean PSA in ng/mL to screen and assess for the recurrence of prostate cancer at each visit is presented.
Effectiveness Parameter for Staging of Prostate Cancer: Metastases at Each Visit
时间窗: time 0 (Baseline), month 3, and every 3 months until disease progression or up to 24 months, whichever came first
The number of participants with metastases that are absent, local tumor, single metastases, multiple metastases in 1 organ, and multiple metastases in multiple organs at each visit is summarized.
Effectiveness Parameter: the Number of Participants With a Complete or Partial Response, Stable Disease, or Progressive Disease Following Treatment at Each Visit
时间窗: month 3, and every 3 months until disease progression or up to 24 months, whichever came first
Response to treatment is summarized by the number of participants at each visit with a complete or partial response, stable disease, or progressive disease. Disease status determination was not predefined, but was based on the judgement of each Investigator.
Effectiveness Parameter for Prognosis: the Number of Participants With a Survival Prognosis of > 10 Years, 5 - 10 Years, 1 - 5 Years, 6 - 12 Months, and < 6 Months
时间窗: time 0 (Baseline), month 3, and every 3 months thereafter until disease progression or up to 24 months, whichever came first
The prognosis for participants is summarized for each visit by the number of participants at each visit with a survival prognosis of 10 years, 5 - 10 years, 1 - 5 years, 6 - 12 months, and \< 6 months. Methods for determining survival prognosis were not prespecified, but were based on the judgement of each Investigator.
Treatment Patterns for Prostate Cancer Treatments: Number of Participants at Each Visit Who Took Lucrin/Lucrin Tridepot, Luteinizing Hormone-releasing Hormone (LHRH) Agonists, Anti-androgens, or Other Drug Treatments, or Who Had Surgery or Radiotherapy.
时间窗: time 0 (Baseline), month 3, and every 3 months until disease progression or up to 24 months, whichever came first
Prostate cancer treatment for all participants is summarized by the number of participants at each visit who took any Lucrin/Lucrin Tridepot, LHRH agonist, anti-androgens, or other drug treatments, or who had any type of surgery or radiotherapy (external radiation or brachytherapy).
次要结局
- Safety Parameter: Number of Participants Reporting Serious Adverse Events (SAEs)(Baseline to disease progression or 24 months, whichever came first)
- Epidemiological Data: Mean Weight(at time 0 (Baseline))
- Epidemiological Data: Mean Age(at time 0 (Baseline))
- Epidemiological Data: Race(at time 0 (Baseline))
- Epidemiological Data: Tumor Staging - Among Participants With a Positive Biopsy, the Number of Participants With Adenocarcinoma Tissue or Other Tissues Recorded for the Positive Biopsy.(at time 0 (Baseline))
- Epidemiological Data: PSA at Baseline(at time 0 (Baseline))
- Epidemiological Data: Tumor Staging (Positive or Negative) Via a Rectal Examination, Prostate Biopsy, Echograph, or Magnetic Resonance Imaging (MRI) Test.(at time 0 (Baseline))
- Epidemiological Data: the Number of Participants With Tumor Stages T0, T1, T2, T3, and T4.(at time 0 (Baseline))
- Epidemiological Data: Node Staging - the Number of Participants With a Positive or Negative Computerized Tomography (CT) Scan or Magnetic Resonance Imaging (MRI) Test(at time 0 (Baseline))
- Epidemiological Data: Node Staging - the Number of Participants With a N0 or N1 Stage at Baseline.(at time 0 (Baseline))
- Epidemiological Data: Bone Scan at Baseline(at time 0 (Baseline))
- Epidemiological Data: Metastasis Staging (M0 or M1) at Baseline(at time 0 (Baseline))