Prospective, Multi-Center, Observational Program to Assess Routine Use of Intermittent Adjuvant Deprivation Therapy With Lucrin Depot in Patients With Advanced Prostate Cancer in the Russian Federation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 主要终点
- Mean Duration of Each Leuprorelin Cycle
研究概览
简要总结
The objective of this study was to describe treatment patterns of leuprorelin over 2 years using an intermittent, adjuvant regimen in participants with advanced prostate cancer (PCa)
详细描述
Participants started hormone treatment with Leuprorelin 3.75 mg once every 28 days, subcutaneously (SC) or intramuscularly (IM). Duration of induction therapy was at least 6 months (6-9 months) during which PSA and testosterone levels were measured every 3 months. When PSA decreased by greater than 90% from baseline (PSA less than 10 ng/ml) or became lower than 4.0 ng/ml (for 2 consecutive measurements made at least 2 weeks apart) the participants were included into intermittent hormone therapy regimen group (IAD). Participants with PSA decrease not achieved greater than 90% or less than or equal to 4.0 ng/ml were given either continuous hormone therapy (CAD) or chemotherapy.
Therapy was stopped if participants had PSA decrease greater than 90% from baseline or values less than 4.0 ng/ml after 6-9 months of continuous hormone therapy. PSA and testosterone were measured every 4 weeks. If PSA became greater than or equal to 10.0 ng/ml, hormone therapy was resumed until PSA was less than 4.0 ng/ml for 2 consecutive measurements made at least 2 weeks apart. Duration of hormonal therapy cycle was at least 3 months. Then intermittent treatment was performed according to a similar scheme. PSA and testosterone levels were determined every 12 weeks when hormone therapy was administered and every 4 weeks after it was stopped. The treatment was carried out for 2 years or until Hormone Refractory Prostate Cancer (HRPC) developed.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed advanced PCa meeting the following criteria:
- •Any Tumor, Node 1, Metastasis 0
- •Any Tumor, Node 0, Metastasis 1 [according to Tumor Node Metastasis classification 2009]
- •Participants planned for administration of leuprorelin
- •World Health Organization status 0-1
- •Life expectancy at least 2 years
排除标准
- •Contraindications to administration of leuprorelin:
- •Hypersensitivity to Leuprorelin similar products of protein origin or any of the excipients in drug product composition
- •Surgical castration
- •Hormone-refractory PCa
- •Presence of another malignant tumor (except skin cancer)
- •Previous administration of hormone therapy with gonadotropin-releasing hormone agonists or antiandrogens
- •Previous administration of radiotherapy or chemotherapy course within 1 month
- •Testosterone level less than or equal to 50 ng/dl (less than or equal to 1.7 mmol/l) at time of inclusion
- •Extremely high level of PSA (greater than or equal to 1000 ng/ml)
- •Other severe diseases in stage of decompensation
- •Other contraindications, that make the participant's participation impossible (by investigator judgment)
- •Previous enrollment in the present program
结局指标
主要结局
Mean Duration of Each Leuprorelin Cycle
时间窗: 24 months
Duration of each cycle of leuprorelin IAD regimen was calculated as (Date of last dose of cycle of leuprorelin minus start date of cycle plus 1)/30.4. The data are reported as mean months +/- standard deviation.
Median Number of Leuprorelin Cycles
时间窗: 24 months
The Participants were on IAD regimen and the data are reported as number of cycles with full range.
Percentage of Participants Who Discontinued From Leuprorelin Administration of IAD Regimen
时间窗: 24 months
The data are reported as percentage of participants.
Mean Duration of Leuprorelin Exposure
时间窗: 24 months
Total duration of leuprorelin Intermittent Androgen Deprivation (IAD) regimen was calculated as (Last dose date of Leuprorelin minus first dose date plus 1)/30.4. If the stop date of leuprorelin administration was missing then the date of last attended visit was used. Total duration may include gaps between the cycles. The data are reported as mean months +/- standard deviation.
Number of Participants Who Switched to IAD Regimen by Visit
时间窗: 24 months
The data are reported as number of participants.
次要结局
- Number of Participants Who Progressed to Hormone Refractory Prostate Cancer (HRPC)(Baseline (enrollment), after 1 year, after 2 years, and 30 days from 2 year visit)
- Median Time to Progression of HRPC(Baseline (enrollment), after 1 year, after 2 years, and 30 days from 2 year visit)
- Median Time to Progression of HRPC in Participants Not Started on IAD Regimen(Baseline (enrollment), after 1 year, after 2 years, and 30 days from 2 year visit)
- Mean Duration of Treatment-off Time in IAD Regimen(Baseline (enrollment), after 1 year, after 2 years, and 30 days from 2 year visit)
- Median Percentage of Time Off-treatment During 2 Years IAD Regimen(Baseline (enrollment), after 1 year, after 2 years, and 30 days from 2 year visit)
- Median Survival Time(Baseline (enrollment), after 1 year, after 2 years, and 30 days from 2 year visit)