Home-Based Exercise for Prostate Cancer

Overseen By Steven Goff

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Paul Viscuse

Must be taking: ADT, ARSI

Must not be taking: Taxane, Platinum, PARP

Disqualifiers: Castrate-resistant prostate cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 12 weeks

24 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two types of home-based exercise programs for men with a specific type of prostate cancer that has spread but still responds to hormone therapy. One group will use a stationary bike for High-Intensity Interval Training (HIIT), while the other will focus on walking. The goal is to determine if these exercises can improve fitness and overall well-being during treatment. Men recently diagnosed with metastatic prostate cancer and beginning hormone therapy might be suitable candidates. As an unphased trial, this study provides a unique opportunity to contribute to research that could enhance the quality of life for future patients.

Do I need to stop my current medications for this trial?

The trial does not specify if you need to stop taking your current medications. However, since the study involves exercise programs for patients starting specific prostate cancer therapies, it's best to discuss your current medications with the trial team.

What prior data suggests that these exercise programs are safe for prostate cancer patients?

A previous study found that high-intensity interval training (HIIT) at home on a stationary bike was safe and effective for improving fitness in people with prostate cancer. Most participants handled it well, and no serious side effects occurred.

For walking exercise, research has shown it is also safe for people with prostate cancer. Studies found only minor issues, like muscle soreness, which are common in exercise programs. Overall, both types of exercise have proven to be well-tolerated with few safety concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these exercise interventions for prostate cancer because they offer a practical, home-based approach that differs from traditional treatments like surgery, radiation, and hormone therapy. The HIIT Cycling intervention provides a structured, high-intensity workout that can be done at home, potentially improving cardiovascular health and reducing cancer-related fatigue more efficiently than standard exercise routines. On the other hand, the Walking intervention offers a low-impact, accessible option for patients who might prefer or require a gentler form of exercise. Both interventions aim to empower patients to actively manage their health and improve their quality of life without the need for hospital visits.

What evidence suggests that this trial's exercise programs could be effective for prostate cancer?

This trial will compare two home-based exercise interventions for prostate cancer: high-intensity interval training (HIIT) cycling and a walking program. Research has shown that performing HIIT at home can enhance heart and lung fitness in both healthy individuals and those with health conditions. Men with prostate cancer who have engaged in supervised HIIT reported significant benefits and often remain motivated to continue. For walking, studies indicate that men who walk briskly for at least 3 hours a week may slow prostate cancer progression by 57%. Additionally, a home-based walking program has helped prostate cancer survivors increase their daily steps. Both exercise methods appear promising for supporting men with prostate cancer. ^{1 2 3 6 7}

Who Is on the Research Team?

Paul Viscuse, MD

Principal Investigator

University of Virginia

Are You a Good Fit for This Trial?

This trial is for patients with newly diagnosed metastatic castrate-sensitive prostate cancer (mCSPC) who are starting ADT/ARSI therapy. Participants will need to complete training at UVA and be able to do aerobic and strength testing before and after a 12-week home-based exercise program.

Inclusion Criteria

Provision of signed and dated informed consent form

Stated willingness to comply with all study procedures and availability for the duration of the study

Ability to read, speak, and understand English.

Exclusion Criteria

I have cancer spread to my bones that affects my ability to walk.

I have had a recent blood clot in my lung.

I have inflammation of the heart muscle.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Training

Participants complete 1-2 training sessions at UVA to experience the exercise level and set up activity monitors

1 week

1-2 visits (in-person)

Treatment

Participants engage in a 12-week home-based exercise program, either a stationary bike or walking intervention

12 weeks

Remote monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment, including post-intervention assessments

2 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Home-Based Exercise Intervention - HIIT Cycling
• Home-Based Exercise Intervention - Walking

Trial Overview The study tests two types of home-based exercise programs: one involving stationary cycling (HIIT Cycling), the other walking. The goal is to see how these exercises affect patients undergoing ADT/ARSI treatment for mCSPC over a period of 12 weeks.

How Is the Trial Designed?

Group I: Arm B Experimental Treatment 1 Intervention

Walking Intervention

Group II: Arm A Experimental Treatment 1 Intervention

HIIT Cycling Intervention

Who Is Running the Clinical Trial?

Paul Viscuse

Lead Sponsor

Trials

1

Recruited

20+

Published Research Related to This Trial

A 10-month study involving 40 prostate cancer patients showed that a home-based progressive resistance exercise training program significantly improved aerobic capacity, upper and lower limb strength, and health-related quality of life compared to a control group that received usual care.

While the exercise program did not significantly affect brachial artery flow-mediated dilatation, it was deemed safe, with only five adverse events reported, indicating that it can be a beneficial addition to recovery after robot-assisted radical prostatectomy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Supported progressive resistance exercise training to counter the adverse side effects of robot-assisted radical prostatectomy: a randomised controlled trial. Ashton, RE., Aning, JJ., Tew, GA., et al.[2021]

A 12-week home-based exercise program significantly increased physical activity levels in colorectal cancer survivors, with no difference in effectiveness between a casually intervened and an intensely intervened group.

Increased physical activity led to beneficial changes in biomarkers associated with colorectal cancer, including reduced insulin and TNF-α levels, and increased IGF-1 and adiponectin levels, indicating potential health benefits for cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a 12-week home-based exercise program on the level of physical activity, insulin, and cytokines in colorectal cancer survivors: a pilot study. Lee, DH., Kim, JY., Lee, MK., et al.[2022]

A 12-week home-based exercise program for men with metastatic castration-resistant prostate cancer (mCRPC) was found to be feasible, with a 47% recruitment rate and a 73% retention rate among participants.

The exercise intervention led to significant improvements in thigh muscle size and endurance, with a 22% increase in muscle cross-sectional area and a 19% increase in time to exhaustion, indicating potential benefits of home-based training during hormone therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of home-based exercise training in men with metastatic castration-resistant prostate cancer. Hanson, ED., Alzer, M., Carver, J., et al.[2023]

In a study of 30 men with localized prostate cancer, preoperative high-intensity interval training (HIIT) did not show a significant difference in tumor natural killer (NK)-cell infiltration compared to usual care, suggesting that HIIT alone may not enhance this immune response.

However, within the group that participated in HIIT, there was a significant increase in NK-cell infiltration when analyzed per protocol, indicating that more consistent exercise sessions may positively influence immune cell activity in tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise training to increase tumour natural killer-cell infiltration in men with localised prostate cancer: a randomised controlled trial. Djurhuus, SS., Simonsen, C., Toft, BG., et al.[2023]

Exercise interventions have a significant positive effect on social functioning (Hedges' g = 0.35) and cognitive functioning (Hedges' g = 0.35) in prostate cancer patients, based on a meta-analysis of 10 randomized controlled trials involving various exercise durations.

Supervised aerobic and resistance exercise sessions lasting 12-48 weeks showed small to medium improvements in social functioning, with only one serious but non-fatal adverse event reported, indicating that exercise is generally safe for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of exercise interventions on social and cognitive functioning of men with prostate cancer: a meta-analysis. Fang, YY., Lee, YH., Chan, JC., et al.[2020]

The EXACT trial demonstrated that a 12-week home-based exercise program was feasible and safe for men with metastatic castrate-resistant prostate cancer (mCRPC), with a high retention rate of 79% and no adverse events reported during the intervention.

Participants experienced significant improvements in functional fitness and reductions in fatigue, indicating that exercise can positively impact health-related quality of life for patients undergoing treatment for mCRPC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of home-based exercise training during adjuvant treatment for metastatic castrate-resistant prostate cancer patients treated with an androgen receptor pathway inhibitor (EXACT). Brown, M., Murphy, MH., McAneney, H., et al.[2023]

Exercise is strongly supported as an effective strategy to manage several adverse effects of androgen deprivation therapy (ADT) in prostate cancer patients, including loss of muscle mass, fatigue, and declining physical function.

In addition to physical benefits, exercise may also improve mental health outcomes such as depression and anxiety, suggesting it plays a crucial role in enhancing overall quality of life and survivorship for men undergoing ADT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of exercise in the management of adverse effects of androgen deprivation therapy for prostate cancer: a rapid review. Edmunds, K., Tuffaha, H., Scuffham, P., et al.[2021]

In a study of 72 prostate cancer patients undergoing radiation therapy, both high-intensity interval training (HIIT) and resistance training (RES) significantly reduced cancer-treatment-related fatigue compared to usual care, indicating their efficacy in managing side effects of treatment.

Both exercise modalities were found to be safe, with no adverse events reported, and they improved functional exercise capacity, demonstrating that structured exercise can be beneficial during cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of high-intensity interval training compared with resistance training in prostate cancer patients undergoing radiotherapy: a randomized controlled trial. Piraux, E., Caty, G., Renard, L., et al.[2021]

A 24-week home-based exercise program for men under active surveillance for prostate cancer showed non-significant decreases in inflammatory cytokine markers, particularly in VEGF and INF-γ, suggesting potential benefits in managing inflammation related to cancer.

The exercise intervention group experienced a non-significant increase in walking distance during a 6-minute walk test, while the control group showed a decrease, indicating that home-based exercise may help maintain physical function during cancer surveillance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot Study on the Impact of a Home-Based Exercise Program on Inflammatory Cytokines and Quality of Life in Men with Prostate Cancer Under Active Surveillance. Moon, C., Gallegos, AM., Sheikh, B., et al.[2022]

A pilot randomized controlled trial involving 25 men with metastatic castrate-resistant prostate cancer (mCRPC) demonstrated that remotely monitored exercise training is feasible, safe, and acceptable, with 82% of participants completing the 12-week program.

Participants showed high adherence to the exercise regimen, completing 90% of aerobic and 96% of resistance training sessions, and reported high satisfaction with the program, indicating strong potential for future studies on exercise's impact on clinical outcomes in this patient group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility, safety, and acceptability of a remotely monitored exercise pilot CHAMP: A Clinical trial of High-intensity Aerobic and resistance exercise for Metastatic castrate-resistant Prostate cancer. Kenfield, SA., Van Blarigan, EL., Panchal, N., et al.[2022]

In a study involving 52 men with prostate cancer on active surveillance, those participating in a 12-week supervised high-intensity interval training (HIIT) program showed excellent adherence, attending 96% of sessions and reporting increased enjoyment and motivation for exercise after the program.

The HIIT group not only felt more in control and confident about their exercise plans compared to the usual care group, but they also faced minimal barriers to participation, indicating that HIIT could be a highly effective and motivating exercise option for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of supervised high-intensity interval training on motivational outcomes in men with prostate cancer undergoing active surveillance: results from a randomized controlled trial. Kang, DW., Boulé, NG., Field, CJ., et al.[2022]

This study will assess the feasibility of a 12-week home-based, moderate-intensity exercise program for men with metastatic castrate-resistant prostate cancer, aiming to improve their quality of life and physical fitness.

The results will inform future larger trials on the efficacy of exercise as a low-toxicity therapy in managing treatment-related side effects in advanced prostate cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise for advanced prostate cancer: a multicomponent, feasibility, trial protocol for men with metastatic castrate-resistant prostate cancer (EXACT). Brown, M., Murphy, M., McDermott, L., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9524100/

Effects of supervised high-intensity interval training on ... Men with prostate cancer on active surveillance were largely motivated and expected significant benefits from a supervised HIIT program.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06429813

Remotely Monitored Exercise Interventions in Patients with ... This study consists of two home-based exercise programs: a stationary exercise bicycle intervention (Arm A), and a walking intervention (Arm B).

3. withpower.com withpower.com/trial/phase-prostatic-neoplasms-6-2024-dc5c2

Home-Based Exercise for Prostate Cancer This study consists of two home-based exercise programs: a stationary exercise bicycle intervention (Arm A), and a walking intervention (Arm B).

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10696712/

Home-based high-intensity interval training improves ... These results indicated that home-based HIIT was an effective intervention for improving cardiorespiratory fitness in healthy adults and patients.

5. sciencedirect.com sciencedirect.com/science/article/pii/S2950273X24000547

Effects of exercise training on prostate cancer It was found that men who walked at a brisk pace for 3 hours or more per week have a 57 % reduced rate of progression than men who walked at an easier pace, ...

6. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/cam4.4324

Feasibility, safety, and acceptability of a remotely ... Exercise may improve clinical and quality of life outcomes for men with prostate cancer. No randomized controlled trials (RCTs) have ...

7. researchgate.net researchgate.net/publication/364022052_Effects_of_supervised_high-intensity_interval_training_on_motivational_outcomes_in_men_with_prostate_cancer_undergoing_active_surveillance_results_from_a_randomized_controlled_trial

(PDF) Effects of supervised high-intensity interval training ... Conclusions The ERASE Trial showed that a 12-week aerobic HIIT program improved several cardiometabolic biomarkers in patients with prostate ...