Localized Prostate CancerASXNCT02435472
Active Surveillance Exercise Clinical Trial
A study testing Exercise and Cardiopulmonary Exercise Test (CPET) in people with Localized Prostate Cancer and Active Surveillance for Prostate Cancer, run by University of California, San Francisco at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Localized Prostate Cancer, Active Surveillance for Prostate Cancer
- What is being tested?
- Exercise and Cardiopulmonary Exercise Test (CPET)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jun 2016to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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.
- 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.
Who cannot join
- 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
Show all 23Show fewer
- 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):
- The same exclusion criteria apply as above. Additionally,
- Should have no prior history of cancer, except for non-melanoma skin cancer
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco
San Francisco, California, 94143
About this study
Official title: A Randomized Clinical Trial of Exercise vs. Usual Care Among Men Opting for Active Surveillance for Prostate Cancer
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.
Read the detailed description
PRIMARY OBJECTIVE:
- 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:
- 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.
- 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.
- Being tested
- Exercise, Cardiopulmonary Exercise Test (CPET)
- Keywords
- Active Surveillance, Exercise, Prostate cancer, Life style, Survey, Personalized exercise, Exercise trainer
- Medical subject headings
- Motor Activity, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
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.
Cardiopulmonary Exercise Test (CPET)Other
Also called CPET
Exercise capacity test to assess peak oxygen consumption (VO2peak)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: Cardiopulmonary Exercise Test (CPET) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 16 weeks
Secondary outcomes (5)
Effect of aerobic training on general anxiety
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.
Measured: At baseline and 16 weeks, 12 months and 24 months after start of intervention
Effect of aerobic training on specific prostate cancer anxiety
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.
Measured: At baseline and 16 weeks, 12 months and 24 months after start of intervention
Adherence to active surveillance
Adherence is measured by the proportion of patients in each study group that remain on active surveillance after 12 months follow-up.
Measured: At 12 months
Adherence to active surveillance
Adherence is measured by the proportion of patients in each study group that remain on active surveillance after 24 months follow-up.
Measured: At 24 months
Messenger ribonucleic acid (mRNA) expression patterns and prognostic scores in tumor and surrounding stromal (normal) tissue
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..
Measured: At baseline and 16 weeks after start of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2015 (estimated)
- Study start21 Jun 2016
- Primary completion30 Apr 2023
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Localized Prostate CancerStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- June Chan, Sc.D., Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02435472
- Sponsor's protocol ID
- 135512
- Other IDs
- 1R01CA181802, NCI-2015-01133
- Acronym
- ASX
- Status last verified
- Apr 2025
- First submitted
- 16 Apr 2015
- Last updated
- 11 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37907387
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Trial of Exercise vs. Usual Care Among Men Opting for Active Surveillance for Prostate Cancer
- ClinicalTrials.gov ID
- NCT02435472
- Acronym / sponsor ID
- ASX / 135512
- Keywords
- Active Surveillance, Exercise, Prostate cancer, Life style, Survey, Personalized exercise, Exercise trainer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 21 Jun 2016 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 6 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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.
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm A: Exercise | Experimental | Behavioral: Exercise, Other: 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 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 | Behavioral: Exercise, Other: 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. |
| Observational Non-Randomized Group | Active comparator | Other: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- 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)
Key exclusion criteria (23 listed)
- 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:
- The same exclusion criteria apply as above. Additionally,
- Should have no prior history of cancer, except for non-melanoma skin cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseThis 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. | Behavioural | Arm A: Exercise, Arm C: Exploratory |
| Cardiopulmonary Exercise Test (CPET)Also: CPETExercise capacity test to assess peak oxygen consumption (VO2peak) | Other | Arm A: Exercise, Arm C: Exploratory, Observational Non-Randomized Group |
Primary outcome
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.
5 secondary outcomes
Effect of aerobic training on general anxiety
Time frame: At baseline and 16 weeks, 12 months and 24 months after start of intervention
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
Adherence to active surveillance
Time frame: At 12 months
Adherence to active surveillance
Time frame: At 24 months
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2025.
- Background: PubMed 37907387Van 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.
- Link to Citation in European Urology Oncology (2024)Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
June Chan, Sc.D. principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise and Cardiopulmonary Exercise Test (CPET) in people with Localized Prostate Cancer and Active Surveillance for Prostate Cancer, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in cardiopulmonary fitness (Arms A, C, and Observational groups only) (time frame: Up to 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02435472, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2025.