The purpose of this study is to determine whether a 12-week, home-based, virtually supervised exercise program will slow cancer progression of prostate cancer among men with prostate cancer at high-risk of progression undergoing active surveillance. The name of the study intervention involved in this study is: Aerobic high-intensity interval training (HIIT) (training exercise intervention)
This research study is a randomized controlled study for a home-based, virtually supervised, aerobic exercise intervention for men with prostate cancer at high-risk of progression undergoing active surveillance. There is evidence that exercise may suppress cancer progression, but the evidence is preliminary. Participants will be randomized into one of two treatment groups: Group A: Aerobic high-intensity interval training (HIIT) versus Group B: Waitlist Control. Randomization means a participant is placed into a study group by chance. The research study procedures include screening for eligibility, study treatment visits, survey questionnaires, blood tests, and follow-up visits. Participation in this research study is expected to last about 14 weeks. It is expected that about 68 people will take part in this research study. The Prostate Cancer Foundation is providing funding for this research study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
68
Home-based, virtually supervised, aerobic exercise program of 36 sessions accessible via internet-enabled tablet (provided to participant if needed). Participants will be supplied with stationary bike, heart rate monitor, and blood pressure monitor.
(Optionally) Home-based, virtually supervised, aerobic exercise program of 36 sessions accessible via internet-enabled tablet (provided to participant if needed). Participants will be supplied with stationary bike, heart rate monitor, and blood pressure monitor.
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
COMPLETEDBrigham and Women's Hospital
Boston, Massachusetts, United States
COMPLETEDDana-Farber Cancer Institute
Boston, Massachusetts, United States
COMPLETEDFred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States
RECRUITINGProstate-Specific Antigen (PSA) Level
The primary outcome is the between-group difference in prostate-specific antigen (PSA) levels post-intervention. Analysis of covariance will be used to detect the difference adjusting for baseline values of the outcome and other covariates.
Time frame: Baseline (Week 1) and post-intervention (Week 14)
Prostate-Specific Antigen (PSA) Velocity
PSA velocity will be calculated following the PSA Working Group Guidelines, using the three most recent PSA values obtained from the medical chart with the first and last values being at least three months apart. The formula was based on the natural logarithm of 2 (0.693) divided by the slope obtained from fitting a linear regression of the natural log of PSA.
Time frame: Baseline (Week 1) and post-intervention (Week 14)
Prostate-Specific Antigen (PSA) Doubling Time
PSA doubling time will be calculated following the PSA Working Group Guidelines, using the three most recent PSA values obtained from the medical chart with the first and last values being at least three months apart. PSA velocity will be used to calculate the number of years that PSA levels become doubles, where the longer the time the better the prognosis.
Time frame: Baseline (Week 1) and post-intervention (Week 14)
Proliferation of LNCaP Prostate Cancer Cell Line
LNCaP cells are androgen-sensitive human prostate adenocarcinoma cells. LNCaP cells will be grown in vitro and their growth rate will be measured by counting the number of cells over time.
Time frame: Baseline (Week 1) and post-intervention (Week 14)
Cardiorespiratory Fitness
Cardiorespiratory fitness will be assessed as VO2peak by a graded maximal or submaximal cycle exercise stress test. VO2peak is defined as the highest values of oxygen uptake averaged among every 30-second interval during the test. VO2peak will be reported in both relative (ml·kg-1·min-1) and absolute (L/min) terms.
Time frame: Baseline (Week 1) and post-intervention (Week 14)
Muscular Strength
Muscular strength will be measured as 1-repetition maximum (RM) (i.e., the greatest resistance that can be moved through the full range of motion), which has been the standard for strength assessments. 1-RM values will be estimated from 10-RM using validated equations on 2 exercises (chest press and leg press).
Time frame: Baseline (Week 1) and post-intervention (Week 14)
Short Physical Performance Battery (SPPB)
Physical function will be assessed by the Short Physical Performance Battery (SPPB), which includes the following 3 lower extremity measures completed in the following order. Timed balance (seconds): Balance will be assessed under 3 conditions (side-by-side, semi-tandem, and tandem stands). Gait speed (seconds): Gait speed will be assessed over a 4-meter flat surface distance. The participant will be asked to complete 2 attempts of this test. Time will be recorded using an electronic timing system. Chair stand (seconds): Chair stand will be performed under 2 conditions: a) subjects will perform a single chair stand; b) subjects will be asked to perform 5 repeated chair stands as quickly as possible; time to completion will be recorded.
Time frame: Baseline (Week 1) and post-intervention (Week 14)
Health-Related Quality of Life
The European Organization for Research and Treatment of Cancer- Quality of Life Questionnaire-C30 (EORTC-QLQ C30) will assess health-related quality of life, consisting of subscales including functional scales (physical, role, cognitive, emotional, social), symptom scales (fatigue, pain, and nausea and vomiting), global health status and quality of life scale, also several single-item symptom measures. The score ranges from 0 to 100 and a higher value indicates a better quality of life.
Time frame: Baseline (Week 1) and post-intervention (Week 14)
Prostate Cancer-Specific Anxiety
Assessed by the Memorial Anxiety Scale for Prostate Cancer (MAX-PC), an 18-item questionnaire with a 4-point Likert-type scale asking how frequently certain "comments made by men about prostate cancer" were true of the respondent. Each item is scored from 0 to 4 with anchors ranging from "Not at all" to "Often."
Time frame: Baseline (Week 1) and post-intervention (Week 14)
Fear of Cancer Progression Assessment
The Fear of Cancer Recurrence Inventory (FCRI) is a well-established scale for in-depth assessment of FCR in research. The short form of this measure (FCRI-SF), consisting of 9 items, has been used as a tool to screen for clinical levels of fear of cancer recurrence (FCR). The FCRI-SF is often used to identify potential cases of clinically significant FCR.
Time frame: Baseline (Week 1) and post-intervention (Week 14)
Sleep Quality
Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI). The PSQI is a self-rated questionnaire which assesses sleep quality and disturbances over a 1-month. The PSQI contains 19 self-rated questions and 5 questions rated by the bed partner or roommate (if one is available). Only self-rated questions are included in the scoring. The self-rated items are combined to form seven "component" scores, each of which has a range of 0-3 points, and they are summed to obtain a global score ranging from 0-21 points, where a higher score indicates worse sleep quality.
Time frame: Baseline (Week 1) and post-intervention (Week 14)
Body Composition
Body composition will be assessed using Bioelectrical Impedance Analysis (BIA). Participants will stand on the device while holding the handles with their arms at their sides, and the device will estimate percent body fat using an algorithm based on age, sex, height, and body weight. Supporting anthropometric measures will include height (stadiometer), body weight (calibrated digital scale), and waist and hip circumference (constant-tension tape measure). Body fat will be reported as a percentage (%), with body weight reported in kilograms (kg).
Time frame: Baseline (Week 1) and post-intervention (Week 14)
Prostate Cancer Symptoms
Prostate cancer-specific symptoms will be assessed using the Expanded Prostate Cancer Index Composite-26 (EPIC-26), a 26-item questionnaire evaluating five domains: urinary incontinence, urinary irritative/obstructive, bowel, sexual, and hormonal function. Each domain is scored from 0 to 100, where a higher score indicates better function and fewer symptoms.
Time frame: Baseline (Week 1) and post-intervention (Week 14)
Exercise Benefits and Barriers
Perceptions of the benefits of and barriers to exercise will be assessed using a study-specific Exercise Benefits/Barriers questionnaire with two parts: perceived benefits/harms of the program (7 items rated -3 \[very much worse\] to +3 \[very much better\], higher = greater benefit) and perceived barriers to completing the program (14 items rated 1 \[not at all\] to 7 \[very much\], higher = greater barriers).
Time frame: Baseline (Week 1) and post-intervention (Week 14)
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