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Exercise Program for Prostate Cancer (ASX Trial)
N/A
Waitlist Available
Led By June Chan, Sc.D.
Research Sponsored by University of California, San Francisco
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
>= 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
Histologically-documented localized (stage < T3) prostate adenocarcinoma
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at baseline and 16 weeks after start of intervention
Awards & highlights
ASX Trial Summary
This trial investigates if a structured exercise program can alter the genomic risk score for prostate cancer and improve prediction of aggressive disease.
Who is the study for?
Men with localized prostate cancer who've chosen active surveillance and have a Gleason score ≤6 or limited Gleason 3+4, a PSA ≤15 ng/ml (or PSAD <0.15), low to moderate fitness levels, and can pass an exercise test are eligible. Exclusions include recent serious cardiovascular events, uncontrolled illnesses, prior prostate cancer treatments, certain medication use within specified time frames before the study start, and mental impairments.Check my eligibility
What is being tested?
This trial examines if a structured aerobic training program over 16 weeks can change genomic risk scores in men with prostate cancer under active surveillance compared to usual care advice. The goal is to see if exercise affects the likelihood of disease progression.See study design
What are the potential side effects?
While specific side effects aren't listed for this exercise-based intervention, participants may experience typical exercise-related issues such as muscle soreness or strain. Serious cardiovascular events are unlikely but monitored due to initial eligibility screening.
ASX Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My prostate biopsy shows a Gleason score of 6 or less, with no aggressive cancer.
Select...
My prostate cancer is in an early stage and not spread far.
ASX Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at baseline and 16 weeks after start of intervention
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at baseline and 16 weeks after start of intervention
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in cardiopulmonary fitness (Arms A, C, and Observational groups only)
Secondary outcome measures
Adherence to active surveillance
Effect of aerobic training on general anxiety
Effect of aerobic training on specific prostate cancer anxiety
+1 moreASX Trial Design
4Treatment groups
Experimental Treatment
Active Control
Group I: Arm A: ExerciseExperimental Treatment2 Interventions
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.
Group II: Arm C: ExploratoryActive Control2 Interventions
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.
Group III: Observational Non-Randomized GroupActive Control1 Intervention
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.
Group IV: Arm B: Usual CareActive Control1 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).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Exercise
2016
Completed Phase 1
~760
Find a Location
Who is running the clinical trial?
University of California, San FranciscoLead Sponsor
2,500 Previous Clinical Trials
15,236,367 Total Patients Enrolled
52 Trials studying Prostate Cancer
17,033 Patients Enrolled for Prostate Cancer
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,049 Total Patients Enrolled
561 Trials studying Prostate Cancer
507,173 Patients Enrolled for Prostate Cancer
June Chan, Sc.D.Principal InvestigatorUniversity of California, San Francisco
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have an active heart infection.I haven't taken finasteride in the last 3 weeks or dutasteride in the last 6 months.I am a man with prostate issues, my PSA is between 10-15, and I have low-risk prostate cancer.I don't have any recent health issues that could worsen with exercise.I am able to understand and follow study procedures.I have unstable chest pain.I have experienced fainting spells more than once.My asthma is not well-managed.I have fluid in my lungs.I have trouble breathing on my own.I chose to monitor my low-risk prostate cancer instead of immediate treatment.My heart health is cleared by a doctor and my ECG is normal for exercise and training.I have severe symptoms from a narrowed heart valve.My heart condition is not well-managed.My prostate biopsy shows a Gleason score of 6 or less, with no aggressive cancer.I have received treatment for prostate cancer.I have not had a heart attack in the last 5 days.I am suspected to have a dissecting aneurysm.I have had a lung clot or tissue death in the past 3 months.I have had blood clots in my legs.My prostate cancer is in an early stage and not spread far.You have a medical condition or disability that makes it unsafe for you to participate in aerobic exercise training.You have a low to moderate level of physical fitness, which will be determined through an interview with the exercise staff and a test called CPET.I have a heart rhythm problem that affects my daily activities or blood pressure.I have inflammation of the heart or its surrounding tissues.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A: Exercise
- Group 2: Arm C: Exploratory
- Group 3: Observational Non-Randomized Group
- Group 4: Arm B: Usual Care
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many volunteers are participating in this experiment?
"Affirmative. The records hosted on clinicaltrials.gov verify that this medical experiment, which initially launched on June 21st 2016, is currently recruiting participants. Approximately 169 individuals are being enrolled from a single location."
Answered by AI
Are there current opportunities for individuals to take part in this clinical experiment?
"The clinicaltrials.gov website suggests that this study is currently seeking participants; the trial was initiated on June 21st 2016 and additional data was last added to its page in April 27th 2022."
Answered by AI
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