DRKS00010310已完成3 期
INTense Exercise foR surviVAL among Men with Metastatic Prostate Cancer (INTERVAL–GAP4): A Multicenter, Randomized, Controlled Phase III Study - INTERVAL–GAP4
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 149
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- Male
入选标准
- •Metastatic castrate-resistant prostate cancer (mCRPC) status: mCRPC patients are defined as adenocarcinoma of the prostate with systemic metastatic disease despite castrate levels of testosterone (<50 ng/dL) due to orchiectomy or LHRH agonist.
- •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:
- •1. Treatment naïve for mCRPC (have not yet started approved therapies for mCRPC, less than 4 weeks on approved therapies is still considered to be treatment naïve).
- •2. Receiving Abiraterone/Enzalutamide/Apalutamide for mCRPC AND responding or stable (PSA values must be stable or declining after at least 4 weeks since starting treatment).
- •3. Patients with PSA progression while on Abiraterone/Enzalutamide/Apalutamide are eligible as long as they are asymptomatic AND there is no intent on starting chemotherapy within 6 months.
- •4. Patients treated with Docetaxel/Cabazitaxel/other approved first line chemotherapy as first line for mCRPC who are asymptomatic without ANY evidence of progression.
- •5. Patients may have progressed following first line Docetaxel/Cabazitaxel/other approved first line chemotherapy and are now receiving treatment with Abiraterone/Enzalutamide/Apalutamide. These patients must absolutely be responding or stable (PSA values stable or declining) and have an estimated life expectancy of more than 1 year.
- •Metastatic hormone-sensitive prostate cancer (mHSPC) status: mHSPC patients are defined as adenocarcinoma of the prostate with systemic metastatic disease that has not progressed while castrate levels of testosterone (<50 ng/dL) were maintained.
- •At enrolment, mHSPC patients must fit into one of the following 3 categories:
- •6. High-risk: defined as having at least two of three criteria: (i) Gleason score =8, (ii) presence of =3 lesions on bone scan, or (iii) presence of measurable visceral lesions.
- •7. High-volume: defined as having the presence of visceral metastases and/or =4 bone metastases with at least one outside of the vertebral column and pelvis.
- •8. High-risk and high-volume: both criteria 6 and 7 apply.
- •Additional inclusion criteria for all groups:
- •- All patients will be required to be on androgen deprivation therapy during the study period or have had a prior bilateral orchiectomy.
- •- =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 3. No serious cardiovascular events within 12 months including, but not limited to, transient ischemic attack, cerebrovascular accident, or myocardial infarction. Patients with a history of hypertensio
排除标准
- •- Small cell neuroendocrine tumours or features of small cell disease.
- •- Brain metastases (brain imaging is not required).
- •- Currently receiving experimental treatment with non-approved drugs at the time of enrolment. Patients must undergo a 28-day washout between last dose and screening visits.
- •- A currently active second malignancy other than non-melanoma skin cancer.
- •- Psychiatric illness, which would prevent the patient from giving informed consent or adhering to the study protocol.
- •- Shortness of breath, chest discomfort, or palpitations when performing activities of daily living, or chest pain brought on by physical activity.
- •- Moderate or severe bone pain (i.e. National Cancer Institute's Common Terminology Criteria for Adverse Events grade 2-3 bone pain).
- •- Ongoing restriction of physical activity with physician documentation.
- •- Participation in vigorous aerobic exercise for more than 60 minutes per week or resistance exercise two or more days per week.
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