Vigorous or Moderate Exercise in Enhancing Active Surveillance in Patients With Localized Prostate Cancer (EASE)

Case Comprehensive Cancer Center (Case CCC)

Status: Withdrawn

Conditions: Stage I Prostate Cancer; Stage IIA Prostate Cancer; Recurrent Prostate Cancer; Stage IIB Prostate Cancer

Treatments: Behavioral: Exercise Logs; Behavioral: vigorous exercise intervention - standard; Behavioral: Adherence; Other: laboratory biomarker analysis; Behavioral: vigorous exercise intervention - cybercycling; Behavioral: moderate exercise intervention; Behavioral: Exercise and body composition test; Other: questionnaire administration

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02179762

NCI-2014-01313 (Registry Identifier)

P30CA043703 (U.S. NIH Grant/Contract)

CASE9814 (Other Identifier)

Details and patient eligibility

About

This randomized pilot clinical trial compares vigorous or moderate exercise in enhancing active surveillance in patients with prostate cancer that has not spread to nearby lymph nodes or to other parts of the body. Active surveillance involves watching the patient's condition but not giving any treatment unless test results show that the patient's condition is getting worse. Exercise may improve fitness, quality of life, brain health, and blood biomarkers in patients with prostate cancer on active surveillance. It is not yet known whether vigorous or moderate exercise works better in enhancing active surveillance in patients with localized prostate cancer.

Full description

PRIMARY OBJECTIVES:

I. To determine the feasibility of performing vigorous intensity aerobic exercise using progressive, high-intensity interval training (HIIT) with standard stationary cycling and 'cybercycling' compared to moderate intensity aerobic exercise with standard stationary cycling in prostate cancer (PCa) survivors on active surveillance (AS).

II. To explore the potential effects of vigorous intensity aerobic exercise (HIIT) using standard cycling and 'cybercycling' compared to moderate intensity standard cycling on changes in quality of life (QoL), cognition, fitness circulating inflammatory biomarkers and PCa-specific markers of progression (prostate specific antigen [PSA], time to AT) in PCa survivors in active surveillance (AS); and, to explore if these effects may be mediated by changes in body fat.

OUTLINE: Patients are randomized to 1 of 3 arms.

ARM I: Patients perform moderate intensity exercise on a stationary bike for 20-50 minutes, three days a week for 16 weeks.

ARM II: Patients perform HIIT exercise on a standard stationary bike, three days a week for 16 weeks.

ARM III: Patients perform HIIT exercise on a cybercycle using racing or other games, three days a week for 16 weeks.

After completion of study, patients are followed up at 6 and 12 months.

Sex: Male

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult men of all races and body size with histologically confirmed localized PCa on AS

• Approved to be contacted by the treating urologist

• Meet screening criteria

  • Complete American Heart Association (AHA)/American College of Sports Medicine (ACSM) exercise questionnaire
  • Undergo cardiopulmonary exercise (CPX) testing utilizing a cycle ergometer. If the CPX test is terminated secondary to hemodynamic instability, arrhythmias or ischemic signs, the patient will be ineligible.

Exclusion criteria

• Patients unable to provide informed consent
• Patients participating in a structured exercise program in the past 6 months
• Patients not available for follow-up tests
• Patients with pre-existing medical conditions that would be a barrier to exercise

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 3 patient groups

Arm I (moderate intensity exercise)

Experimental group

Description:

Patients perform moderate intensity exercise on a stationary bike for 20-50 minutes, three days a week for 16 weeks.

Treatment:

Behavioral: Exercise and body composition test

Behavioral: Adherence

Other: laboratory biomarker analysis

Other: questionnaire administration

Behavioral: moderate exercise intervention

Behavioral: Exercise Logs

Arm II (HIIT exercise on a standard stationary bike)

Experimental group

Description:

Patients perform HIIT exercise on a standard stationary bike, three days a week for 16 weeks.

Treatment:

Behavioral: Exercise and body composition test

Behavioral: Adherence

Other: laboratory biomarker analysis

Other: questionnaire administration

Behavioral: Exercise Logs

Behavioral: vigorous exercise intervention - standard

Arm III (HIIT exercise on a cybercycle)

Experimental group

Description:

Patients perform HIIT exercise on a cybercycle using racing or other games, three days a week for 16 weeks.

Treatment:

Behavioral: Exercise and body composition test

Behavioral: Adherence

Other: laboratory biomarker analysis

Other: questionnaire administration

Behavioral: vigorous exercise intervention - cybercycling

Behavioral: Exercise Logs