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

Trial Summary

What is the purpose of this trial?

This study consists of two home-based exercise programs: a stationary exercise bicycle intervention (Arm A), and a walking intervention (Arm B). The study will enroll 24 patients who are starting ADT (Androgen Deprivation Therapy)/ARSI (Androgen-Receptor Signaling Inhibitors) therapy for newly diagnosed metastatic castrate-sensitive prostate cancer (mCSPC). All participants will be asked to complete 1-2 training sessions at UVA prior to starting the exercise. All participants will be asked to complete aerobic and strength testing before and after the exercise program. Participants will be asked to answer questionnaires throughout the program. The at-home exercise will last for 12 weeks.

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 data supports the effectiveness of the home-based exercise treatment for prostate cancer?

Research suggests that exercise, including home-based programs, can help manage side effects and improve quality of life for men with prostate cancer. High-intensity interval training (HIIT) and moderate-intensity exercise have shown potential benefits in physical fitness and motivation, which may support their use in managing prostate cancer. ^{1 2 3 4 5}

Is home-based exercise, like HIIT cycling or walking, safe for people with prostate cancer?

Exercise, including high-intensity interval training (HIIT) and home-based programs, is generally considered safe and can help manage side effects of prostate cancer treatments, such as fatigue and quality of life issues. ^{2 6 7 8 9}

How is the home-based exercise treatment for prostate cancer different from other treatments?

This home-based exercise treatment, which includes high-intensity interval training (HIIT) cycling and walking, is unique because it allows prostate cancer patients to exercise at home, increasing accessibility and potentially improving quality of life without the need for supervised sessions. Unlike traditional treatments, it focuses on physical activity to mitigate side effects of hormone therapy and enhance social and cognitive functioning. ^{2 4 10 11 12}

Research Team

Paul Viscuse, MD

Principal Investigator

University of Virginia

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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 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]

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]

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]

References

1. Germany 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). [2023]

2. England 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. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Exercise for advanced prostate cancer: a multicomponent, feasibility, trial protocol for men with metastatic castrate-resistant prostate cancer (EXACT). [2023]

4. Germany pubmed.ncbi.nlm.nih.gov

Effects of exercise interventions on social and cognitive functioning of men with prostate cancer: a meta-analysis. [2020]

5. United States 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. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Exercise training to increase tumour natural killer-cell infiltration in men with localised prostate cancer: a randomised controlled trial. [2023]

7. Germany 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. [2022]

8. Germany 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. [2021]

9. England 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. [2021]

10. England pubmed.ncbi.nlm.nih.gov

Feasibility of home-based exercise training in men with metastatic castration-resistant prostate cancer. [2023]

11. United States 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. [2022]

12. Germany 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. [2021]