A Randomized Clinical Trial of Exercise vs. Usual Care Among Men Opting for Active Surveillance for Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- Change in cardiopulmonary fitness (Arms A, C, and Observational groups only)
研究概览
简要总结
This phase 2, open-label, dual-center, two-arm randomized controlled trial (RCT) investigates the effects of 16 weeks of structured aerobic training, relative to usual care (print material with physical activity guidance). Prostate genomic signatures represent the functional activity of all genes in the genome and are converted into genomic risk scores which correspond to the probability of a progression event (chance of having more aggressive disease). A structured exercise program may alter the genomic risk score and improve prediction of aggressive disease.
详细描述
PRIMARY OBJECTIVE:
I. Determine the effect of remotely monitored, tailored aerobic training, compared to usual care (print material with physical activity guidance), on cardiopulmonary fitness in men on active surveillance for low-risk prostate cancer.
SECONDARY OBJECTIVES:
I. To determine the effect of aerobic training, compared with usual care, on prostate genomic signatures that predict risk of prostate cancer progression or aggressive disease; and messenger ribonucleic acid (mRNA) expression patterns in tumor and surrounding stromal (normal) tissue.
II. To determine the effect of aerobic training, compared with usual care, on patient-reported outcomes including active surveillance-specific anxiety, stress, & adherence.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •ARM A and ARM B:
- •Histologically-documented localized (stage < T3) prostate adenocarcinoma
- •Patient has selected active surveillance as their management strategy for low- or low-intermediate risk prostate cancer as defined below
- •>= 10 core prostate biopsy completed prior to randomization with Gleason sum =< 6 with no pattern 4, or Gleason 3+4 in < 34% of all cores
- •Diagnostic or most recent prostate specific antigen (PSA) =< 15 ng/ml, or PSA density (PSAD) < 0.15
- •Low to moderate fitness level at baseline (to be assessed via interview with the exercise staff and through the CPET)
- •Clearance based on medical chart review and normal electrocardiogram (ECG) (administered by a trained health professional) to undergo a symptom-limited cardiopulmonary exercise test and aerobic training intervention
- •Able to achieve and complete an acceptable cardiopulmonary exercise test defined as follows: achieving peak or plateau in oxygen consumption concurrent with increased power output; a respiratory exchange ratio >= 1.1 or volitional exhaustion-rating of perceived exertion > 19
- •English-speaking
- •A priori, we will allow men with concurrent benign prostatic hyperplasia (prostate volume > 50 g) to have a PSA between 10-15 ng/ml; and include men with low volume Gleason 3+4 disease, because such men have similar outcomes on active surveillance to those with Gleason =< 3+3; also a priori, we will allow men with < than a 10 core biopsy at the discretion of the urologist if s/he classifies the patient as "low-risk" and a good candidate for active surveillance based on other favorable features (e.g., tumor molecular tests, prostate imaging, etc.)
- •NON-CANCER CONTROL GROUP (EXPLORATORY ARM C):
- •Healthy males age 20-35 or >=60 yrs.
- •No history of prostate cancer or other cancer.
- •Medical clearance based on medical chart review and normal ECG (administered by a trained health professional) to undergo a symptom-limited cardiopulmonary exercise test and aerobic training intervention OR medical clearance based on medical chart review and sub-maximal exercise testing for the remote aerobic training intervention.
- •English-speaking.
- •Low to moderate fitness level at baseline (to be assessed via interview with the exercise staff and through the CPET; similar to Arms A and B); subjects will be frequency-matched to subjects in the prostate cancer exercise intervention group (Arm A) to have a similar distribution of body mass index and facilitate comparisons between these two groups.
- •NON-RANDOMIZED OBSERVATIONAL COMPONENT ELIGIBILITY:
- •Histologically-documented localized (stage < T3) prostate adenocarcinoma.
- •Undergoing or initiating active surveillance.
- •Medical clearance based on medical chart review and normal ECG (administered by a trained health professional) to undergo a symptom-limited cardiopulmonary exercise test and aerobic training intervention.
- •English-speaking.
排除标准
- •Any prior or concurrent treatment for prostate cancer
- •Use of finasteride or dutasteride within 3 weeks or 6 months, respectively, of study entry
- •Uncontrolled illness, physical disability, or other contraindication to aerobic exercise training including, but not limited to:
- •Acute myocardial Infarction (within 5 days of any planned study procedure)
- •Unstable angina
- •Uncontrolled arrhythmia causing symptoms or hemodynamic compromise
- •Recurrent syncope
- •Active endocarditis
- •Acute myocarditis or pericarditis
- •Symptomatic severe aortic stenosis
- •Uncontrolled heart failure
- •Acute (within 3 months) pulmonary embolus or pulmonary infarction
- •Thrombosis of lower extremities
- •Suspected dissecting aneurysm
- •Uncontrolled asthma
- •Pulmonary edema
- •Room air desaturation at rest =< 85%
- •Respiratory failure
- •Acute non-cardiopulmonary disorders that may affect exercise performance or be aggravated by exercise (ie infection, renal failure, thyrotoxicosis)
- •Mental impairment leading to inability to cooperate
- •NON-RANDOMIZED OBSERVATIONAL AND INTERVENTION COMPONENTS (ARM C):
- •The same exclusion criteria apply as above. Additionally,
- •Should have no prior history of cancer, except for non-melanoma skin cancer
研究组 & 干预措施
Arm A: Exercise
Arm A will engage in up to 4 aerobic sessions per week at 55% to 75% of the individually determined exercise capacity (VO2peak; determined from the cardiopulmonary exercise test (CPET) performed at baseline) for 16 weeks. This exercise prescription will be achieved through ~ 4 sessions / week. Men are provided with a heart rate monitor to help ensure they exercise in their target zone. At baseline & week 16, all patients will complete: (1) lifestyle and quality-of-life questionnaires, (2) measurement of weight (3) collection of research fasting blood sample, (4) collection of urine sample, and (5) cardiorespiratory fitness testing. Archival biopsy tissue samples from before and after the intervention will also be requested.
干预措施: Exercise (Behavioral)
Arm A: Exercise
Arm A will engage in up to 4 aerobic sessions per week at 55% to 75% of the individually determined exercise capacity (VO2peak; determined from the cardiopulmonary exercise test (CPET) performed at baseline) for 16 weeks. This exercise prescription will be achieved through ~ 4 sessions / week. Men are provided with a heart rate monitor to help ensure they exercise in their target zone. At baseline & week 16, all patients will complete: (1) lifestyle and quality-of-life questionnaires, (2) measurement of weight (3) collection of research fasting blood sample, (4) collection of urine sample, and (5) cardiorespiratory fitness testing. Archival biopsy tissue samples from before and after the intervention will also be requested.
干预措施: Cardiopulmonary Exercise Test (CPET) (Other)
Arm B: Usual Care
Arm B will receive print material with physical activity guidance which includes general physical activity information (e.g., "Moving through Cancer - A Guide to Exercise for Cancer Survivors") at baseline, but no specific exercise program or goals. At the conclusion of the 16 weeks, subjects in this group will be provided with a heart rate monitor, an individualized aerobic exercise program based on their cardiorespiratory fitness test results, and opportunity to consult with study exercise physiologist (one-time).
Arm C: Exploratory
Arm C is a non-randomized control group of men without cancer, which will receive all baseline and 16 week follow-up assessments (except tissue procurement) will engage in up to 4 aerobic sessions per week at 55% to 75% of the individually determined exercise capacity (VO2peak; determined from the cardiopulmonary exercise test performed at baseline) for 16 weeks. This exercise prescription will be achieved through ~ 4 sessions / week. Men are provided with a heart rate monitor to help ensure they exercise in their target zone. At baseline & week 16, all patients will complete: (1) lifestyle and quality-of-life questionnaires, (2) measurement of weight (3) collection of research fasting blood sample, (4) collection of urine sample, and (5) cardiorespiratory fitness testing.
干预措施: Exercise (Behavioral)
Arm C: Exploratory
Arm C is a non-randomized control group of men without cancer, which will receive all baseline and 16 week follow-up assessments (except tissue procurement) will engage in up to 4 aerobic sessions per week at 55% to 75% of the individually determined exercise capacity (VO2peak; determined from the cardiopulmonary exercise test performed at baseline) for 16 weeks. This exercise prescription will be achieved through ~ 4 sessions / week. Men are provided with a heart rate monitor to help ensure they exercise in their target zone. At baseline & week 16, all patients will complete: (1) lifestyle and quality-of-life questionnaires, (2) measurement of weight (3) collection of research fasting blood sample, (4) collection of urine sample, and (5) cardiorespiratory fitness testing.
干预措施: Cardiopulmonary Exercise Test (CPET) (Other)
Observational Non-Randomized Group
There is also a non-randomized observational component to the study where biospecimens and survey data will be collected and one CPET will be administered. Individuals who will be enrolled to this group include those who do not meet all eligibility criteria for the RCT, or those who do not wish to be in a RCT, but are interested to participate in some lifestyle research.
干预措施: Cardiopulmonary Exercise Test (CPET) (Other)
结局指标
主要结局
Change in cardiopulmonary fitness (Arms A, C, and Observational groups only)
时间窗: Up to 16 weeks
Change in cardiopulmonary fitness as indicated by V02max (from CPET) will be compared across each arm. All analyses will employ the intention-to-treat (ITT) approach. Every attempt will be made to complete the week 16 follow-up assessment on all patients.
次要结局
- Effect of aerobic training on general anxiety(At baseline and 16 weeks, 12 months and 24 months after start of intervention)
- Effect of aerobic training on specific prostate cancer anxiety(At baseline and 16 weeks, 12 months and 24 months after start of intervention)
- Adherence to active surveillance(At 24 months)
- Messenger ribonucleic acid (mRNA) expression patterns and prognostic scores in tumor and surrounding stromal (normal) tissue(At baseline and 16 weeks after start of intervention)
- Adherence to active surveillance(At 12 months)