Longitudinal Evaluation of Adding Docetaxel to ADT and Novel Hormone Treatment for Patients With High Volume Metastatic Hormone Sensitive Prostate Cancer in Order to Assess Relative Effectiveness: the Case of "Triple" Versus "Double" Therapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,400
- 试验地点
- 2
- 主要终点
- Mortality
研究概览
简要总结
Lead4Care is an observational, open-label, multicenter study evaluating the effectiveness, tolerance, and cost-effectiveness of triple against double therapy in matched groups of mHSPC patients with high tumor burden. In addition to androgen deprivation therapy (ADT), the triple constitutes of docetaxel and novel hormonal therapy (NHT), and the double of NHT therapy in addition to ADT.
Their effectiveness is compared in terms of mortality and morbidity, which is captured by HRQoL, pain, fatigue. Potential side effects are captured by neuropathy, diarrhea, constipation, anxiety, sickness, and dyssomnia. The cost-effectiveness is evaluated within a Markov model from a societal perspective in which the main disease stages are mHSPC, mCRPC and death.
In connection with a regular visit in hospital care, prostate cancer patients who in addition to ADT will initiate double or triple therapy are offered participation in the study. If they consent on-line, they will receive 13 online surveys over a 60-month period. The surveys are sent with an interval of two months for the first six months, quarterly thereafter until two years, and thereafter yearly.
Once all participants have been recruited, the baseline data shared by healthcare personnel and patients will be enriched with registry data. This baseline and registry data involves information about the patients' historical and current health- and socioeconomic status. Thereby, Lead4Care will be able to identify comparable groups of patients on triple and double treatments by using advanced matching methods.
In order to assure an objective analysis, Lead4Care will not allow any data extraction until Lead4Care has predefined and published all details regarding the comparison. The existing protocol is then complemented with information on exactly which patients will be compared across triple and double therapy, and how outcomes will be compared.
For these treatments, the main objectives are to:
- Compare mortality and morbidity on triple and double therapy, and their relative side-effects.
- Capture patient preferences for these different treatment outcomes over time.
- Evaluate cost-effectiveness of triple versus double therapy from a societal perspective.
详细描述
Comprehensive evaluation:
The treatment landscape of metastatic hormone-sensitive prostate cancer (mHSPC) is evolving rapidly and treatment guidelines often need to be made before the effectiveness of available combinations have been compared. Such is the case for the current recommendation to combine androgen deprivation therapy (ADT) with new hormonal therapy (NHT) and docetaxel (DTX). This triple therapy has not yet been directly evaluated against the alternative of ADT and NHT, i.e., the double therapy. The therapies have only been evaluated indirectly in the trials PEACE-1 and ARASENS. Lead4Care will evaluate triple against double therapy with regard to potential differences in disease progression as well as tolerance. Thereby, Lead4Care will do a comprehensive comparative effectiveness (CE) evaluation which can contribute to the pool of evidence important for future guidelines.
Observational design:
Lead4Care leaves the treatment choice to the clinicians and the patients, and uses advanced matching methods to ensure comparability between patients receiving triple- and double therapy. As the groups are expected to differ in terms of their tolerance to DTX, and the doctors' valuation of tolerance differ, Lead4Care expect to be able to identify such matching groups on a subset of enrolled patients. The matched groups will be used for the CE evaluation. Patients will consequently be enrolled and followed prospectively irrespective of which therapy the clinicians will choose, and similar groups will be matched especially with regard to their tolerance to DTX as proxied by their age, comorbidity, ECOG collected within Lead4Care but also in terms of their health- and socioeconomic status (SES) in general requested from national registries. The matched groups will be as similar as expected in a randomized experiment in terms of tolerance in particular, but also in terms of health, and SES. Consequently, there is no need for randomization to ensure comparability, using this study design.
Lean observational design:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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 eligible for inclusion in this study must meet all of the following criteria:
- •Patients should have initiated triple or double therapy no longer than 3 months from the start of ADT,
- •Patients must have mHSPC at the time of enrolment, and visceral metastases or four or more bone metastases (of which at least one is outside the axial skeleton.
- •Patients must be ≥ 18 years old at the time of enrolment. Note: NHT could be abiraterone acetate, apalutamide, darolutamide or enzalutamide.
排除标准
- •Participants meeting any of the of the following criteria are not eligible for inclusion:
- •Patients who do not understand written and/or oral instructions in Swedish.
研究组 & 干预措施
Triple therapy
Patients with mHSPC and high tumour burden receiving treatment with androgen deprivation treatment, new hormone therapy (abiraterone, apalutamide, enzalutamide or darolutamide) and docetaxel.
干预措施: ADT + NHT + Docetaxel (Drug)
Double therapy
Patients with mHSPC and high tumour burden receiving treatment with androgen deprivation treatment and new hormone therapy (abiraterone, apalutamide, enzalutamide or darolutamide).
干预措施: ADT + NHT (Drug)
结局指标
主要结局
Mortality
时间窗: : Measured at month 2, 4, 6, 9, 12, 15, 18, 21, 24, 36, 48, 60 and thereafter annually until month 144 (12 years).
Death due to any causes, i.e., overall survival (OS). captured by the Swedish National Cause of Death Register.
次要结局
- Fatigue(Measured at baseline and month 2, 4, 6, 12, 18, 24, 36, 48 and 60.)
- Time to progression(Measured at month 2, 4, 6, 9, 12, 15, 18, 21, 24, 36, 48 and 60.)
- Time to first line treatment of mCRPC(Measured at month 2, 4, 6, 9, 12, 15, 18, 21, 24, 36, 48, 60 and thereafter annually until month 144 (12 years).)
- Pain intensity(Measured at baseline and month 6, 12, 18, 24, 36, 48, and 60.)