Active Surveillance Exercise Clinical Trial (ASX)

This is an interventional supportive care trial for Localized Prostate Cancer focused on measuring Active Surveillance, Exercise, Prostate cancer, Life style, Survey, Personalized exercise, Exercise trainer Read More

Inclusion Criteria

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.

Exclusion Criteria

• 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