Skip to main content

Summary

for males ages 18 years and up (full criteria)
at San Francisco, California
study started
estimated completion:

Description

Summary

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.

Official Title

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

Details

This is a PI initiated, randomized clinical trial of exercise vs. usual care among men opting for active surveillance for prostate cancer. The AS RCT study is a randomized controlled trial of 16-weeks aerobic exercise (e.g., brisk walking) vs. usual care among 150 men with prostate cancer on active surveillance. After obtaining written informed consent, enrolled subjects will be scheduled for the baseline assessments. The men randomized to the Intervention Arm will engage in an individually tailored aerobic exercise program (home-based walking) following the principles of aerobic exercise training guidelines for adults as recommended by the American College of Sports Medicine (ACSM). The men in the Control Arm will be asked to continue their typical exercise practices for 16 weeks. Men in both arms will be asked to complete questionnaires at baseline and at week 16, months 12 & 24. Specimens from biopsy will be reviewed by the investigators' collaborator, GenomeDx, for RNA characterization and assessment of the genomic risk scores.

There is also a non-randomized observational component to the study where we will collect biospecimens, survey, data, and administer one CPET. 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. This group also provides us with a larger more heterogeneous population to follow long term to examine associations between exercise, biomarkers, fitness metrics, and clinical and psychosocial outcomes.

Keywords

Localized Prostate Cancer Active Surveillance for Prostate Cancer Active Surveillance Exercise Prostate cancer Life style Survey Personalized exercise Exercise trainer Prostatic Neoplasms

Eligibility

You can join if…

Open to males ages 18 years and up

  • Histologically-documented localized (stage <T3) prostate adenocarcinoma;
  • Undergoing or initiating active surveillance;
  • ≥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; AND residual tumor tissue from such biopsy is obtainable and donated for the research;
  • Diagnostic PSA ≤10 ng/ml;
  • 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 <T3) prostate adenocarcinoma;
  • Undergoing or initiating active surveillance;
  • Biopsy prior to study enrollment that is obtainable AND has sufficient residual tumor tissue from such biopsy is obtainable and donated for the research.
  • 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

You CAN'T join if...

  • 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.

Location

  • University of CA San Francisco accepting new patients
    San Francisco, California, 94158, United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT02435472
Phase
Phase 2
Lead Scientist
June Chan
Study Type
Interventional
Last Updated
April 3, 2017
I’m interested in this study!