Exercise Therapy for Prostate Cancer

Recruiting at 9 trial locations

Overseen By Behfar Ehdaie, MD, MPH

Age: 18+

Sex: Male

Trial Phase: Phase 2

Sponsor: Memorial Sloan Kettering Cancer Center

Disqualifiers: Metastatic malignancy, Anticancer therapy, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

102 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is studying how regular walking exercises at home affect people with low-risk prostate cancer who are being monitored but not actively treated. Participants will either follow a specific walking routine or continue their usual exercise habits. Researchers aim to see if the walking routine has any impact on prostate cancer indicators.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on exercise therapy and does not mention medication changes.

What data supports the effectiveness of the treatment Exercise Therapy for Prostate Cancer?

Research shows that physical activity after a prostate cancer diagnosis can slow disease progression and improve survival rates. Exercise also helps reduce side effects from treatments like androgen deprivation therapy, such as increased fat mass and fatigue, improving overall quality of life. ^{1 2 3 4 5}

Is exercise therapy safe for humans, particularly for those with prostate cancer?

Exercise therapy is generally considered safe for humans, including those with prostate cancer, and can help manage adverse effects of treatments like androgen deprivation therapy. ^{6 7 8 9 10}

How is exercise therapy different from other treatments for prostate cancer?

Exercise therapy is unique because it focuses on improving physical fitness and quality of life for prostate cancer patients, especially those undergoing treatments like androgen deprivation therapy (ADT), which can cause muscle loss and other side effects. Unlike traditional medical treatments, exercise therapy helps counteract these effects by enhancing strength, mobility, and overall well-being. ^{1 2 11 12 13}

Research Team

Lee Jones, PhD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

This trial is for men over 18 with low-risk prostate cancer who are under active surveillance, not very active (exercising less than 150 minutes per week), have a BMI below 40, and pass an exercise safety check. It's not for those on other treatments or programs that affect tumor outcomes, with any history of systemic anticancer therapy or distant metastatic malignancy.

Inclusion Criteria

Inactive, defined as not meeting the national exercise guidelines for cancer patients (<150 minutes/week of moderate or vigorous exercise) as assessed by remote activity and heart rate tracking for a 7-day period prior to study entry (general physical activity screening assessment via smart watch)

I am 18 years old or older.

Screening clearance by an MSK Exercise Physiologist (i.e., review of ECG and PAR-Q)

Exclusion Criteria

Enrollment in any other program that may alter the impact of exercise on tumor outcomes (e.g., weight loss program)

My cancer has spread to distant parts of my body.

I haven't had any initial treatment for prostate cancer in the last 5 years.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Exercise Therapy

Participants engage in regular home-based walking sessions on a treadmill, assigned by an exercise physiologist

6-12 months

Regular home-based sessions

Follow-up

Participants are monitored for changes in molecular, radiologic, and pathologic markers after the intervention

6-12 months

Treatment Details

Interventions

• Exercise Therapy

Trial Overview The study tests the effects of home-based treadmill walking sessions designed by an exercise physiologist against usual exercise routines in managing indicators of prostate cancer. Participants will either follow the assigned walking program or continue their regular exercises to see which has a better impact on prostate health.

Participant Groups

Group I: Participants Assigned to Exercise Therapy Experimental Treatment 1 Intervention

Participants with histologically confirmed localized prostate cancer undergoing active surveillance

Group II: Participants Assigned to Usual Care Active Control 1 Intervention

Participants with histologically confirmed localized prostate cancer undergoing active surveillance

Exercise Therapy is already approved in United States, European Union for the following indications:

Approved in United States as Exercise Therapy for:

• Improvement of cardiorespiratory fitness in men with low-risk prostate cancer on active surveillance
• Reduction of urinary obstruction/irritation and fear of recurrence in men with low-risk prostate cancer on active surveillance

Approved in European Union as Exercise Therapy for:

• General health and wellness
• Prevention of chronic diseases through physical activity

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Findings from Research

A systematic review of 12 studies involving patients with stage I-IV prostate cancer found that aerobic exercise significantly improves quality of life compared to other forms of exercise.

Despite the positive findings, the variability in study methodologies and quality of life measurement tools introduces potential biases in the analysis, highlighting the need for more standardized research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical exercise and quality of life in patients with prostate cancer: systematic review and meta-analysis. Rendeiro, JA., Rodrigues, CAMP., de Barros Rocha, L., et al.[2021]

Exercise, particularly resistance training and small-sided games, significantly helps preserve bone mineral density and lean mass in prostate cancer patients undergoing androgen deprivation therapy (ADT), based on a review of 14 randomized controlled trials with participant numbers ranging from 19 to 163.

These exercise interventions also improve muscle strength and physical performance, highlighting the importance of incorporating multimodal exercise programs in the care of men with prostate cancer on ADT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effect of Exercise on Body Composition and Physical Performance in Prostate Cancer Patients Undergoing Androgen Deprivation Therapy (ADT): A Narrative Synthesis. Logan, L., Toohey, K., Kavanagh, PS., et al.[2021]

The EX+D (exercise and dietary) intervention significantly improved body composition in prostate cancer patients undergoing androgen deprivation therapy, showing reductions in fat mass and increases in lean mass compared to standard care.

Improvements in body composition from the EX+D intervention were associated with better mobility performance and strength, highlighting its potential benefits for physical function in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a lifestyle intervention on body composition in prostate cancer patients on androgen deprivation therapy. Chaplow, ZL., Focht, BC., Lucas, AR., et al.[2022]

Physical activity after a prostate cancer diagnosis is linked to slower disease progression and improved survival rates, as shown by various observational studies and clinical trials.

The review provides evidence-based recommendations for healthcare providers on how to effectively incorporate specific types of physical activity into treatment plans for prostate cancer patients, addressing the need for guidance on exercise interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What Should We Tell Patients About Physical Activity After a Prostate Cancer Diagnosis? Ramalingam, S., Pollak, KI., Zullig, LL., et al.[2020]

A 6-month dietary and physical activity intervention for 94 prostate cancer patients undergoing androgen deprivation therapy (ADT) significantly reduced weight, body mass index, and fat mass compared to a control group, indicating its efficacy in managing side effects of ADT.

The intervention improved functional capacity and dietary habits, demonstrating that lifestyle changes can positively influence health outcomes for men receiving ADT, although it did not significantly affect fatigue, quality of life, or stress levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomised controlled trial to evaluate the efficacy of a 6-month dietary and physical activity intervention for patients receiving androgen deprivation therapy for prostate cancer. O'Neill, RF., Haseen, F., Murray, LJ., et al.[2018]

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]

Exercise significantly improves muscle strength, exercise tolerance, and helps manage body fat and sexual function in prostate cancer patients undergoing androgen deprivation therapy (ADT), based on a meta-analysis of 15 studies with 1135 participants.

No significant differences were found between aerobic and resistance exercise in alleviating ADT-related obesity, fatigue, or exercise tolerance, and exercise duration was linked to reduced fatigue levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise overcome adverse effects among prostate cancer patients receiving androgen deprivation therapy: An update meta-analysis. Yunfeng, G., Weiyang, H., Xueyang, H., et al.[2021]

Exercise interventions, including aerobic and resistance training, are safe for men undergoing androgen-deprivation therapy for prostate cancer and can improve muscular strength, cardiorespiratory fitness, functional performance, and reduce fatigue.

While exercise shows promise in mitigating some adverse effects of treatment, the effects on bone health, cardiometabolic risk, and quality of life remain unclear, indicating a need for further high-quality research to establish specific exercise guidelines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of exercise on treatment-related adverse effects for patients with prostate cancer receiving androgen-deprivation therapy: a systematic review. Gardner, JR., Livingston, PM., Fraser, SF.[2022]

Resistance exercise (RE) is shown to be a safe and effective method to improve muscular strength, performance, fatigue, and quality of life in prostate cancer patients undergoing androgen deprivation therapy, based on a systematic review of studies published until September 2014.

While RE has clear benefits for physical performance and quality of life, the evidence regarding its effects on cardiovascular performance, body composition, and other health markers remains inconclusive, highlighting the need for further research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of resistance exercise on physical performance and health-related quality of life in prostate cancer patients: a systematic review. Hasenoehrl, T., Keilani, M., Sedghi Komanadj, T., et al.[2022]

A supervised exercise program combining endurance and resistance training significantly improved various health markers in 27 prostate cancer patients undergoing androgen-deprivation therapy, including muscular endurance and cardiorespiratory fitness.

Participants also experienced improvements in quality of life, as evidenced by better performance in the six-minute walk test and reduced depression levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Evaluation of a supervised six-month exercise program in patients with prostate cancer receiving androgen-deprivation therapy]. Caty, G., Salazar Gajardo, S., Butoescu, V., et al.[2019]

The 'Football Club (FC) Prostate' study is a randomized trial involving 80 men undergoing androgen deprivation therapy (ADT) for advanced prostate cancer, aiming to evaluate the effects of soccer training on various health outcomes over a 12-week period.

The primary focus is on changes in lean body mass, with secondary outcomes including cardiovascular function and patient-reported quality of life, potentially demonstrating that soccer training can be a safe and effective rehabilitation strategy for men receiving ADT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of recreational soccer in men with prostate cancer undergoing androgen deprivation therapy: study protocol for the 'FC Prostate' randomized controlled trial. Uth, J., Schmidt, JF., Christensen, JF., et al.[2021]

Regular physical activity is beneficial for cancer patients, including those with prostate cancer, as it helps improve function and quality of life during treatment and rehabilitation.

Exercise can mitigate the side effects of cancer and its treatments, such as hormonal therapy, by preventing declines in fitness, strength, and mobility, which are often exacerbated by inactivity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The role of exercise in prostate cancer prevention and treatment]. Biró, K., Géczi, L.[2019]

This study aims to evaluate the safety and efficacy of a 3-month modular multi-modal exercise program for 90 prostate cancer survivors with bone metastases, addressing concerns about muscle atrophy and functional impairments due to prior treatments.

The exercise program is designed to be safe for patients with bone metastases, potentially improving physical function and delaying skeletal complications, which could significantly enhance the quality of life for these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of a modular multi-modal exercise program in prostate cancer patients with bone metastases: a randomized controlled trial. Galvão, DA., Taaffe, DR., Cormie, P., et al.[2022]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Physical exercise and quality of life in patients with prostate cancer: systematic review and meta-analysis. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

The Effect of Exercise on Body Composition and Physical Performance in Prostate Cancer Patients Undergoing Androgen Deprivation Therapy (ADT): A Narrative Synthesis. [2021]

3. Germany pubmed.ncbi.nlm.nih.gov

Effects of a lifestyle intervention on body composition in prostate cancer patients on androgen deprivation therapy. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

What Should We Tell Patients About Physical Activity After a Prostate Cancer Diagnosis? [2020]

5. United States pubmed.ncbi.nlm.nih.gov

A randomised controlled trial to evaluate the efficacy of a 6-month dietary and physical activity intervention for patients receiving androgen deprivation therapy for prostate cancer. [2018]

6. 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]

7. United States pubmed.ncbi.nlm.nih.gov

Exercise overcome adverse effects among prostate cancer patients receiving androgen deprivation therapy: An update meta-analysis. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Effects of exercise on treatment-related adverse effects for patients with prostate cancer receiving androgen-deprivation therapy: a systematic review. [2022]

9. Germany pubmed.ncbi.nlm.nih.gov

The effects of resistance exercise on physical performance and health-related quality of life in prostate cancer patients: a systematic review. [2022]

10. Belgium pubmed.ncbi.nlm.nih.gov

[Evaluation of a supervised six-month exercise program in patients with prostate cancer receiving androgen-deprivation therapy]. [2019]

11. England pubmed.ncbi.nlm.nih.gov

Effects of recreational soccer in men with prostate cancer undergoing androgen deprivation therapy: study protocol for the 'FC Prostate' randomized controlled trial. [2021]

12. Hungary pubmed.ncbi.nlm.nih.gov

[The role of exercise in prostate cancer prevention and treatment]. [2019]

13. England pubmed.ncbi.nlm.nih.gov

Efficacy and safety of a modular multi-modal exercise program in prostate cancer patients with bone metastases: a randomized controlled trial. [2022]