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Active Surveillance Exercise Clinical Trial (ASX)

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ClinicalTrials.gov Identifier: NCT02435472
Recruitment Status : Recruiting
First Posted : May 6, 2015
Last Update Posted : August 24, 2021
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of California, San Francisco

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.

Condition or disease Intervention/treatment Phase
Localized Prostate Cancer Active Surveillance for Prostate Cancer Behavioral: Exercise Other: Cardiopulmonary Exercise Test (CPET) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 169 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Randomized Clinical Trial of Exercise vs. Usual Care Among Men Opting for Active Surveillance for Prostate Cancer
Actual Study Start Date : June 21, 2016
Estimated Primary Completion Date : February 28, 2022
Estimated Study Completion Date : February 28, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Arm A: Exercise
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
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.

Other: Cardiopulmonary Exercise Test (CPET)
Exercise capacity test to assess peak oxygen consumption (VO2peak)
Other Name: CPET

No Intervention: Arm B: Usual Care
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).
Active Comparator: Arm C: Exploratory
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
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.

Other: Cardiopulmonary Exercise Test (CPET)
Exercise capacity test to assess peak oxygen consumption (VO2peak)
Other Name: CPET

Active Comparator: Observational Non-Randomized Group
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)
Exercise capacity test to assess peak oxygen consumption (VO2peak)
Other Name: CPET




Primary Outcome Measures :
  1. Change in cardiopulmonary fitness (Arms A, C, and Observational groups only) [ Time Frame: Up to 16 weeks ]
    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.


Secondary Outcome Measures :
  1. Effect of aerobic training on general anxiety [ Time Frame: At baseline and 16 weeks, 12 months and 24 months after start of intervention ]
    Subject will complete the State Trait Anxiety Inventory (STAI) for Adults survey to assess general anxiety scores. The survey measures state and trait anxiety, with 20 questions, and each question can be scored as 1-4 points. Higher scores indicate greater anxiety and the score range is 20-80.

  2. 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 ]
    Subjects will complete the Memorial Anxiety Scale for Prostate Cancer (MAXPC) survey to assess specific prostate cancer anxiety. Higher scores indicate greater anxiety and the fear of cancer recurrence score ranges from 0 to 12.

  3. Adherence to active surveillance [ Time Frame: At 12 months ]
    Adherence is measured by the proportion of patients in each study group that remain on active surveillance after 12 months follow-up.

  4. Adherence to active surveillance [ Time Frame: At 24 months ]
    Adherence is measured by the proportion of patients in each study group that remain on active surveillance after 24 months follow-up.

  5. Messenger ribonucleic acid (mRNA) expression patterns and prognostic scores in tumor and surrounding stromal (normal) tissue [ Time Frame: At baseline and 16 weeks after start of intervention ]
    Effect of aerobic training on mRNA expression patterns using the 1.4 million marker Affymetrix 1.0 Human Exon Array, in formalin-fixed paraffin-embedded (FFPE) prostate biopsy tissue taken before and after the intervention interval..



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  • 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):

• Should have no prior history of cancer, except for non-melanoma skin cancer


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02435472


Contacts
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Contact: June Chan 877-827-3222 cancertrials@ucsf.edu
Contact: Imelda Tenggara 415-353-7348 imelda.tenggara@ucsf.edu

Locations
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United States, California
University of CA San Francisco Recruiting
San Francisco, California, United States, 94158
Contact: June Chan    877-827-3222    cancertrials@ucsf.edu   
Contact: Imelda Tenggara    415-353-7348    imelda.tenggara@ucsf.edu   
Principal Investigator: June M. Chan, ScD         
Sponsors and Collaborators
University of California, San Francisco
National Cancer Institute (NCI)
Investigators
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Principal Investigator: June Chan, Sc.D. University of California, San Francisco
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02435472    
Other Study ID Numbers: 135512
1R01CA181802 ( U.S. NIH Grant/Contract )
NCI-2015-01133 ( Registry Identifier: NCI Clinical Trials Reporting Program (CTRP) )
First Posted: May 6, 2015    Key Record Dates
Last Update Posted: August 24, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of California, San Francisco:
Active Surveillance
Exercise
Prostate cancer
Life style
Survey
Personalized exercise
Exercise trainer
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases