Home-Based Exercise for Prostate Cancer

Recruiting in Palo Alto (17 mi)

Overseen by Paul Viscuse, MD

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Paul Viscuse

Must be taking: ADT, ARSI

Must not be taking: Taxane, Platinum, PARP

Disqualifiers: Castrate-resistant prostate cancer, others

No Placebo Group

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}

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.

Trial 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 (Behavioural Intervention)
• Home-Based Exercise Intervention - Walking (Behavioural Intervention)

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University of Virginia Charlottesville, VA

Who Is Running the Clinical Trial?

Paul Viscuse Lead Sponsor

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] Exercise is an effective adjuvant therapy that can alleviate treatment-related toxicities for men with prostate cancer (PC). However, the feasibility of delivering exercise training to men with advanced disease and the wider impact on clinical outcomes remain unknown. The purpose of the EXACT trial was to determine the feasibility and effects of home-based exercise training in men with metastatic castrate-resistant prostate cancer (mCRPC).

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] Understanding the motivational effects of supervised aerobic high-intensity interval training (HIIT) may help men with prostate cancer undergoing active surveillance initiate and maintain exercise behavior, however, few studies have addressed this question. This report explored exercise motivation in men with prostate cancer undergoing active surveillance participating in a randomized exercise trial.

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] Men with metastatic castrate-resistant prostate cancer can experience an array of treatment-related side effects. Accumulating evidence suggests exercise may alleviate some of these adversities and assist in disease management. However, empirical evidence in advanced prostate cancer patients remains limited. The purpose of this study is to determine whether men with metastatic prostate cancer, who are ineligible for high-intensity exercise, can partake in a home-based, moderate-intensity exercise program and the impact of doing so on quality of life and physical fitness parameters.

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] Exercise is beneficial for prostate cancer patients' physical functioning; however, effects on social and cognitive functioning are inconsistent. This meta-analysis of exercise interventions for prostate cancer patients had two aims: the primary aim was to evaluate the effects of exercise interventions on social functioning; the secondary aim was to consider additional outcomes of cognitive functioning as well as adverse events.

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] This study aimed to demonstrate potential translation of pre-clinical studies to a home-based exercise intervention in mediating inflammatory cytokine markers and tumor progression in men under active surveillance for prostate cancer.

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] To explore the effects of preoperative high-intensity interval training (HIIT) compared to usual care on tumour natural killer (NK)-cell infiltration in men with localised prostate cancer (PCa), as NK-cell infiltration has been proposed as one of the key mechanisms whereby exercise can modulate human tumours.

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] The purposes of this study are to examine (1) the feasibility and efficacy of two different home-based exercise protocols on the level of physical activity (PA), and (2) the effect of increased PA via home-based exercise program on biomarkers of colorectal cancer.

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] Prostate cancer (PCa) is the most commonly diagnosed cancer in Australia, accounting for one quarter of all new cancer diagnoses for males. Androgen deprivation therapy (ADT) is the standard first-line therapy for metastatic PCa but is also used across much of the spectrum of disease. Unfortunately, debilitating adverse effects are a significant and largely unavoidable feature of ADT. A recent systematic review of adverse effects of ADT identified 19 sub-groups classified according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. The potential for multiple simultaneous adverse effects, their associated management and the impact of adverse effects on cancer outcomes and quality of life are important considerations in the treatment and supportive care of men with PCa. Exercise is increasingly being recognized as an efficacious strategy in managing these adverse effects.

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] Exercise training has shown beneficial effects in the management of radiotherapy-related side effects in prostate cancer (PCa) patients undergoing radiation therapy (RT). However, the optimal modality of the exercise programs have not been yet determined. The aim of this randomized controlled trial was to investigate the effects of high-intensity interval training (HIIT) and resistance training (RES) compared to usual care (UC) on cancer-treatment-related fatigue (CTRF) (primary outcome), quality of life, depression, daytime sleepiness, insomnia, sleep quality, functional exercise capacity and executive function in PCa patients during RT.

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

Feasibility of home-based exercise training in men with metastatic castration-resistant prostate cancer. [2023] Home-based training increases accessibility to exercise and mitigates the side effects of hormone therapy for prostate cancer (PC). However, it is unknown if men with more advanced disease are willing to partake in such interventions.

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] Exercise may improve clinical and quality of life outcomes for men with prostate cancer. No randomized controlled trials (RCTs) have examined the feasibility, safety, and acceptability of remote exercise training in men with metastatic castrate-resistant prostate cancer (mCRPC).

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] To investigate the effects of a supported home-based progressive resistance exercise training (RET) programme on indices of cardiovascular health, muscular strength and health-related quality of life (HR-QoL) in prostate cancer (PCa) patients after treatment with robot-assisted radical prostatectomy (RARP).