NCT02435472Completed
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 · Last updated 11 Apr 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 104 (actual)
- First submitted
- 16 Apr 2015
- Start date
- 21 Jun 2016
- Primary completion date
- 30 Apr 2023
- Lead sponsor
- University of California, San Francisco
- Diseases
- Prostate cancer
- NCT number
- NCT02435472
What you commit to
- Study type: Interventional
- Participants enrolled: 104
- From 21 Jun 2016 to the primary completion date, 30 Apr 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Any prior or concurrent treatment for prostate cancer
Other illness
- 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
Other
- Use of finasteride or dutasteride within 3 weeks or 6 months, respectively, of study entry
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of California San Francisco Coordinator of this site? Confirm its status | San Francisco | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.