NCT02730338进行中（未招募）不适用
INTense ExeRcise for SurviVAL Among Men with Metastatic Prostate Cancer (INTERVAL - GAP4): a Multicentre, Randomised, Controlled, Phase III Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 866
- 试验地点
- 18
- 主要终点
- Overall Survival
研究概览
简要总结
To determine if supervised high intensity aerobic and resistance training increases overall survival compared to self-directed exercise in patients with metastatic prostate cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •mCRPC status:
- •mCRPC patients defined as; adenocarcinoma of the prostate with systemic metastatic disease despite castrate levels of testosterone (<50 ng/dL) due to orchiectomy or LHRH agonist.
- •o Patients must have one or more of the following to be considered mCRPC
- •Metastatic Disease Progression: >20% increase in the sum of diameters of measurable lesions from the time of maximal regression or appearance of one or more new lesions.
- •Bone Scan Progression: Appearance of one or more new lesions on bone scan attributable to prostate cancer.
- •PSA Progression: PSA ≥2 ng/ml that has risen serially on at least two occasions, each at least one week apart (PSA1 < PSA2 < PSA3).
- •PSMA PET/CT scan progression: Appearance of one or more new lesions on PSMA PET/CT scan attributable to prostate cancer.
- •At enrolment, mCRPC patients must fit into one of the following 5 categories:
- •Treatment naïve for mCRPC (have not yet started approved therapies for CRPC ie: Abiraterone/Enzalutamide/Apalutamide / or Docetaxel, Cabazitaxel or other approved first line chemotherapy; less than 4 weeks on approved therapies is still considered to be treatment naïve) Or
- •Receiving Abi/Enza/Apa for mCRPC AND responding or stable (PSA values must be stable or declining after at least 4 weeks since starting Abi/Enza/Apa for mCRPC) Or
- •Patients with PSA progression while on Abi/Enza/Apa are eligible as long as they are asymptomatic AND there is no intent on starting chemotherapy within 6 months Or
- •Patients treated with Docetaxel, Cabazitaxel or other approved first line chemotherapy as first line for mCRPC who are asymptomatic without ANY evidence of progression Or
- •Patients may have progressed following first line Docetaxel, Cabazitaxel or other first line chemotherapy and are now receiving treatment with Abi/Enza/Apa. These patients must absolutely be responding or stable (PSA values must be stable or declining after starting Abi/Enza/Apa treatment) and have an estimated life expectancy of more than 1 year.
- •mHSPC Status:
- •mHSPC patients must be classified as either high-risk or high-volume mHSPC. These groups are defined as adenocarcinoma of the prostate with systemic metastatic disease and patients also fit into one of the following 2 categories:
- •High-risk: defined as having at least 2 of three criteria: (i) Gleason score ≥8, (ii) presence of ≥3 lesions on bone scan, or (iii) presence of INTERVAL Protocol Version 5.0, 19 August 2019 4 measurable visceral lesions (PSMA PET imaging should not be used in the definition of high-risk disease) Or
- •High-volume: defined as having the presence of visceral metastases and/or ≥ four bone metastases with at least one outside of the vertebral column and pelvis (PSMA PET imaging should not be used in the definition of high-volume disease)
- •Additional criteria for all groups:
- •All patients will be required to be on ADT during the study period or have had a prior bilateral orchiectomy.
- •Men with small cell neuroendocrine tumours or features of small cell disease are not eligible.
- •≥4 weeks since last major surgery and fully recovered.
- •No known contraindications to high intensity exercise, including, but not limited to: brain metastases; current congestive heart failure (New York Heart Association Class II, III or IV); serious or non-healing wound, ulcer, or bone fracture; spinal cord compromise or instrumentation due to metastatic disease; peripheral neuropathy ≥grade
- •No serious cardiovascular events within 12 months including, but not limited to, transient ischemic attack (TIA), cerebrovascular accident (CVA), or myocardial infarction (MI). Patients with a history of hypertension must be well-controlled (< 160/90) on anti-hypertensive therapy.
- •Halabi Nomogram score <1951 (Risk Category rated as low or intermediate risk)
- •Age ≥18 years
- •Required Baseline Laboratory Values: ANC ≥ 1500/uL; Platelet count ≥ 100,000/uL; Creatinine ≤ 1.5 x upper limits of normal; Bilirubin ≤ 1.5 x upper limits of normal; AST ≤ 1.5 x upper limits of normal; Serum testosterone ≤ 50 ng/dL
- •ECOG performance status 0-1
- •Medical clearance by treating physician to undergo a symptom-limited cardiopulmonary exercise test and vigorous aerobic and resistance exercise training, and able to complete an acceptable cardiopulmonary exercise test.
- •Exercise Coordination Centre (ECC) review and approval of subject's screening bone scan / areas with bone metastases.
- •Men participating in vigorous aerobic exercise for >60 min/week or structured resistance exercise ≥2 days/week, are not eligible.
- •Subject is willing and able to use technological aspects of the trial.
- •The subject is fluent in the language as designated by the institution at which he would be enrolled.
排除标准
- 未提供
结局指标
主要结局
Overall Survival
时间窗: up to 5 years
Overall survival will be measured from the time of randomization until death
次要结局
- Quality of Life(up to 5 years)
- Symptomatic Skeletal Related Events (SSE)(up to 5 years)
- Physical Function(up to 5 years)
- Pain(up to 5 years)
- Opiate Use(up to 5 years)
- Analgesic Use(up to 5 years)
- Disease Progression(up to 5 years)
- Biomarker analysis(up to 5 years)
研究者
研究点 (18)
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