Clinical trial · Interventional
Active Surveillance Exercise Clinical Trial
A Randomized Clinical Trial of Exercise vs. Usual Care Among Men Opting for Active Surveillance for Prostate Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Active Surveillance for Prostate Cancer | — | UNRESOLVED | — |
| Localized Prostate Cancer | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cardiopulmonary Exercise Test (CPET) | Other | — | UNRESOLVED |
| Exercise | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Arm A: Exercise
- description
- 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.
- interventionNames
- Behavioral: Exercise
- Other: Cardiopulmonary Exercise Test (CPET)
- type
- NO_INTERVENTION
- label
- Arm B: Usual Care
- description
- 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).
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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 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. 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): The same exclusion criteria apply as above. Additionally, • Should have no prior history of cancer, except for non-melanoma skin cancer
References
Publications (1)
- BACKGROUNDVan 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