Active Surveillance Exercise Clinical Trial

NCT02435472 | Completed DMC

• 3 other identifiers: 1355121R01CA181802NCI-2015-01133
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief Summary

This phase 2, open-label, dual-center, two-arm randomized controlled trial (RCT) investigates the effects of 16 weeks of structured aerobic training, relative to usual care (print material with physical activity guidance). Prostate genomic signatures represent the functional activity of all genes in the genome and are converted into genomic risk scores which correspond to the probability of a progression event (chance of having more aggressive disease). A structured exercise program may alter the genomic risk score and improve prediction of aggressive disease.

Conditions

Localized Prostate Cancer; Active Surveillance for Prostate Cancer

Keywords

Active Surveillance; Exercise; Prostate cancer; Life style; Survey; Personalized exercise; Exercise trainer

Outcome Measures

Primary Outcomes (1)

• Change in cardiopulmonary fitness (Arms A, C, and Observational groups only)

  Change in cardiopulmonary fitness as indicated by V02max (from CPET) will be compared across each arm. All analyses will employ the intention-to-treat (ITT) approach. Every attempt will be made to complete the week 16 follow-up assessment on all patients.

  Up to 16 weeks

Secondary Outcomes (5)

• Effect of aerobic training on general anxiety

  At baseline and 16 weeks, 12 months and 24 months after start of intervention

• Effect of aerobic training on specific prostate cancer anxiety

  At baseline and 16 weeks, 12 months and 24 months after start of intervention

• Adherence to active surveillance

  At 12 months

• Adherence to active surveillance

  At 24 months

• Messenger ribonucleic acid (mRNA) expression patterns and prognostic scores in tumor and surrounding stromal (normal) tissue

  At baseline and 16 weeks after start of intervention

Study Arms (4)

Arm A: Exercise

EXPERIMENTAL

Arm A will engage in up to 4 aerobic sessions per week at 55% to 75% of the individually determined exercise capacity (VO2peak; determined from the cardiopulmonary exercise test (CPET) performed at baseline) for 16 weeks. This exercise prescription will be achieved through \~ 4 sessions / week. Men are provided with a heart rate monitor to help ensure they exercise in their target zone. At baseline \& week 16, all patients will complete: (1) lifestyle and quality-of-life questionnaires, (2) measurement of weight (3) collection of research fasting blood sample, (4) collection of urine sample, and (5) cardiorespiratory fitness testing. Archival biopsy tissue samples from before and after the intervention will also be requested.

Behavioral: Exercise; Other: Cardiopulmonary Exercise Test (CPET)

Arm B: Usual Care

NO INTERVENTION

Arm B will receive print material with physical activity guidance which includes general physical activity information (e.g., "Moving through Cancer - A Guide to Exercise for Cancer Survivors") at baseline, but no specific exercise program or goals. At the conclusion of the 16 weeks, subjects in this group will be provided with a heart rate monitor, an individualized aerobic exercise program based on their cardiorespiratory fitness test results, and opportunity to consult with study exercise physiologist (one-time).

Arm C: Exploratory

ACTIVE COMPARATOR

Arm C is a non-randomized control group of men without cancer, which will receive all baseline and 16 week follow-up assessments (except tissue procurement) will engage in up to 4 aerobic sessions per week at 55% to 75% of the individually determined exercise capacity (VO2peak; determined from the cardiopulmonary exercise test performed at baseline) for 16 weeks. This exercise prescription will be achieved through \~ 4 sessions / week. Men are provided with a heart rate monitor to help ensure they exercise in their target zone. At baseline \& week 16, all patients will complete: (1) lifestyle and quality-of-life questionnaires, (2) measurement of weight (3) collection of research fasting blood sample, (4) collection of urine sample, and (5) cardiorespiratory fitness testing.

Behavioral: Exercise; Other: Cardiopulmonary Exercise Test (CPET)

Observational Non-Randomized Group

ACTIVE COMPARATOR

There is also a non-randomized observational component to the study where biospecimens and survey data will be collected and one CPET will be administered. 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.

Other: Cardiopulmonary Exercise Test (CPET)

Interventions

Exercise BEHAVIORAL

This open-label, two-arm randomized controlled trial (RCT) will investigate the effects of 16 weeks of structured aerobic training, relative to usual care (print material with physical activity guidance) in 76 men with histologically confirmed low-risk prostate adenocarcinoma on active surveillance. The only investigational therapeutic agent being tested in this trial is a behavioral intervention in the form of aerobic training.

Arm A: Exercise; Arm C: Exploratory

Cardiopulmonary Exercise Test (CPET) OTHER

Exercise capacity test to assess peak oxygen consumption (VO2peak)

Also known as: CPET

Arm A: Exercise; Arm C: Exploratory; Observational Non-Randomized Group

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

Related Publications (1)

• Van Blarigan EL, Kenfield SA, Olshen A, Panchal N, Encabo K, Tenggara I, Graff RE, Bang AS, Shinohara K, Cooperberg MR, Carroll PR, Jones LW, Winters-Stone K, Luke A, Chan JM. Effect of a Home-based Walking Intervention on Cardiopulmonary Fitness and Quality of Life Among Men with Prostate Cancer on Active Surveillance: The Active Surveillance Exercise Randomized Controlled Trial. Eur Urol Oncol. 2024 Jun;7(3):519-526. doi: 10.1016/j.euo.2023.10.012. Epub 2023 Oct 29.

  PMID: 37907387 BACKGROUND

Related Links

• Link to Citation in European Urology Oncology (2024)

MeSH Terms

Conditions

Motor Activity; Prostatic Neoplasms

Interventions

Exercise; Exercise Test; Clostridium perfringens epsilon-toxin

Condition Hierarchy (Ancestors)

Behavior; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Ergometry; Investigative Techniques

Study Officials

• June Chan, Sc.D.

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2015
• First Posted: May 6, 2015
• Study Start: June 21, 2016
• Primary Completion: April 30, 2023
• Study Completion: December 31, 2024
• Last Updated: April 11, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)