A Randomized Clinical Trial of Exercise vs. Usual Care Among Men Opting for Active Surveillance for Prostate Cancer

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A Randomized Clinical Trial of Exercise vs. Usual Care Among Men Opting for Active Surveillance for Prostate Cancer

Condition: Localized Prostate Cancer, Active Surveillance for Prostate Cancer

Intervention:

  • Behavioral: Exercise

Purpose: The AS RCT study is a randomized controlled trial of 16-weeks aerobic exercise (home-based walking) vs. usual care among 150 men with prostate cancer on active surveillance.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02435472

Sponsor: University of California, San Francisco

Primary Outcome Measures:

  • Measure: Genomic signature changes
  • Time Frame: At baseline and 16 weeks after start of intervention
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Messenger ribonucleic acid (mRNA) expression patterns in tumor and surrounding stromal (normal) tissue
  • Time Frame: At baseline and 16 weeks after start of intervention
  • Safety Issue:
  • Measure: Effect of aerobic training on general anxiety
  • Time Frame: At baseline and 16 weeks, 12 months and 24 months after start of intervention
  • Safety Issue:
  • Measure: Effect of aerobic training on specific prostate cancer anxiety
  • Time Frame: At baseline and 16 weeks, 12 months and 24 months after start of intervention
  • Safety Issue:
  • Measure: Adherence to active surveillance
  • Time Frame: At 12 and 24 months
  • Safety Issue:

Estimated Enrollment: 150

Study Start Date: May 2016

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: Male

Inclusion Criteria:

  • Histologically-documented localized (stage < li>
  • 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 at least 2mm of tumor and Gleason sum ≤6 with no pattern 4, or Gleason 3+4 in <34% of all cores;
  • Diagnostic or most recent 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 Protocol Protocol staff and through CPET);
  • 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
  • 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 >50g) to have a PSA between 10-15 ng/ml; and include men with low volume Gleason 3+4 disease. 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.). Sufficient tumor will be determined based on review of pathology notes and if needed, consultation with study pathologist. Current criteria for “sufficient” includes: >=1mm tumor and >=25% of available sample is tumor. Non-Randomized Observational Component Eligibility: Eligibility for the non-randomized observational component are:
  • Histologically-documented localized (stage < li>
  • 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;57
  • 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); and
  • Mental impairment leading to inability to cooperate. Non-Randomized Observational Component:
  • The same

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;57
  • 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); and
  • Mental impairment leading to inability to cooperate. Non-Randomized Observational Component:
  • The same exclusion criteria apply as above.

Contact:

  • June Chan
  • 877-827-3222

Location:

  • University of CA San Francisco
  • San Francisco California 94158 United States

View trial on ClinicalTrials.gov

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