Active Surveillance Exercise Clinical Trial

Korábbi kezelés

• Any prior or concurrent treatment for prostate cancer

Más betegség

• 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

Egyéb

• Use of finasteride or dutasteride within 3 weeks or 6 months, respectively, of study entry

• 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.