Active Surveillance Exercise Clinical Trial
- Conditions
- Localized Prostate CancerActive Surveillance for Prostate Cancer
- Interventions
- Other: Cardiopulmonary Exercise Test (CPET)Behavioral: Exercise
- Registration Number
- NCT02435472
- Lead Sponsor
- 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.
- Detailed Description
PRIMARY OBJECTIVE:
I. Determine the effect of remotely monitored, tailored aerobic training, compared to usual care (print material with physical activity guidance), on cardiopulmonary fitness in men on active surveillance for low-risk prostate cancer.
SECONDARY OBJECTIVES:
I. To determine the effect of aerobic training, compared with usual care, on prostate genomic signatures that predict risk of prostate cancer progression or aggressive disease; and messenger ribonucleic acid (mRNA) expression patterns in tumor and surrounding stromal (normal) tissue.
II. To determine the effect of aerobic training, compared with usual care, on patient-reported outcomes including active surveillance-specific anxiety, stress, \& adherence.
III. To procure blood, urine and paraffin embedded prostate tissue for future exploratory studies.
IV. To conduct correlative science examining associations between measures of cardiopulmonary fitness, clinical features, and biomarkers of prognosis.
V. To evaluate and compare circulating and urinary biomarkers (e.g., metabolomics, proteomics) among men in Arms A, B, and C.
OUTLINE: This study is a randomized controlled trial of 16-weeks aerobic exercise (home-based walking) versus (vs.) usual care among 64 men with prostate cancer on active surveillance. There is also a non-randomized observational component to the study where we will collect biospecimens, survey, data, and administer one cardiopulmonary exercise test (CPET).
ARM A: Patients undergo structured aerobic training comprising four treadmill walking sessions a week at 55% to 75% of the individually determined exercise capacity for 16 weeks. Men are provided with a heart rate monitor to help ensure they exercise in their target zone. At baseline \& week 16 (-7, +7 days), all patients complete: (1) lifestyle and quality-of-life questionnaires, (2) measurement of weight and waist circumference (3) collection of research fasting blood sample, (4) transrectal ultrasound-guided clinical biopsy, and (5) cardiorespiratory fitness testing. Archival tissue specimens from standard of care biopsies are also collected, pre/post intervention.
ARM B (USUAL CARE): Patients undergo usual care and are provided with general physical activity information ("Moving through Cancer-A Guide to Exercise for Cancer Survivors") at baseline. At the conclusion of the 16 weeks, subjects in this group will be provided with a free session with an exercise physiologist and an individualized aerobic exercise program based on their cardiorespiratory fitness test results. Archival tissue specimens from standard of care biopsies are also collected, pre/post intervention.
ARM C (NON-RANDOMIZED CONTROL GROUP): Control group of men without cancer, with a lower baseline fitness level (assessed as part of screening), who will receive all baseline and 16 week follow-up assessments (except tissue procurement), and the same intervention as Arm A. Subjects undergo structured aerobic training comprising four treadmill walking sessions a week at 55% to 75% of the individually determined exercise capacity for 16 weeks. Men are provided with a heart rate monitor to help ensure they exercise in their target zone. At baseline \& week 16 (-7, +7 days), all patients complete: (1) lifestyle and quality-of-life questionnaires, (2) measurement of weight and waist circumference (3) collection of research fasting blood sample, (4) cardiorespiratory fitness testing.
OBSERVATIONAL GROUP (NON-RANDOMIZED): Biospecimens, survey, data, and administer one CPET will be collected. 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.
After completion of study, patients in Arms A \& B are followed up at 16 weeks, 12 months, and 24 months. Non-randomized participants (Arm C) are followed-up at 16 weeks, and Observational study participants are asked to complete surveys at 12 and 24 months.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 104
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Observational Non-Randomized Group Cardiopulmonary Exercise Test (CPET) 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. Arm C: Exploratory Cardiopulmonary Exercise Test (CPET) 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. Arm A: Exercise Cardiopulmonary Exercise Test (CPET) 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. Arm A: Exercise 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. Arm C: Exploratory Exercise 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.
- Primary Outcome Measures
Name Time Method Change in cardiopulmonary fitness (Arms A, C, and Observational groups only) 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
Name Time Method Adherence to active surveillance 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.
Effect of aerobic training on general anxiety 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.
Effect of aerobic training on specific prostate cancer anxiety 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.
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 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..
Trial Locations
- Locations (1)
University of California, San Francisco
🇺🇸San Francisco, California, United States