Exercise Therapy for Prostate Cancer

Not currently recruiting at 9 trial locations

Overseen By Jessica Scott, PhD

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the impact of regular exercise, specifically home-based treadmill walking, on prostate cancer indicators in men with low-risk prostate cancer who are not currently undergoing treatment. Participants will either follow an assigned exercise plan with guidance from an exercise physiologist or maintain their usual exercise routines. The trial aims to compare the effects of these routines on prostate cancer indicators. Men with localized prostate cancer who have not been meeting national exercise guidelines are potential candidates for this trial. As a Phase 2 trial, the research focuses on assessing the effectiveness of the exercise intervention in an initial, smaller group, offering participants a chance to contribute to important findings.

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 prior data suggests that exercise therapy is safe for people with prostate cancer?

Research shows that exercise therapy is generally safe for people with prostate cancer. Studies have found that exercise can reduce tiredness, improve quality of life, and enhance physical abilities during cancer treatment. One study found that being active might lessen side effects like tiredness and bone loss, suggesting that exercise is well-tolerated by people with prostate cancer.

Previous patients who engaged in various exercises, such as aerobic and resistance training, did not report major negative effects. This supports the idea that exercise is a safe option for men with prostate cancer. Overall, evidence suggests that exercise therapy is safe and may benefit people with low-risk prostate cancer who are being closely monitored. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about exercise therapy for prostate cancer because it offers a non-invasive approach to managing the condition. Unlike traditional treatments like surgery, radiation, or hormone therapy, exercise therapy focuses on improving overall health and potentially slowing cancer progression through physical activity. This approach could reduce side effects and enhance quality of life for patients, making it a promising complementary option in the management of localized prostate cancer.

What evidence suggests that exercise therapy might be an effective treatment for prostate cancer?

Research shows that exercise can help men with prostate cancer. In this trial, participants will join either an Exercise Therapy group or a Usual Care group. Studies have found that physical activity improves health for those under close monitoring for prostate cancer. Exercise can reduce tiredness, enhance quality of life, and boost physical ability. In some studies, men who regularly exercised after prostate cancer treatment experienced significant improvements in their activity levels. Overall, exercise programs have led to better health and well-being for men with prostate cancer. ^{1 2 6 7 8}

Who Is on the Research Team?

Jessica Scott, PhD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

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)

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

BMI <40 kg/m^2

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.

Any other condition or intercurrent illness that, in the opinion of the investigator, makes the subject a poor candidate for study participation

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10854832/

The Impact of Physical Activity on the Outcomes ... The present review explores the impact of physical activity (PA) on patients with prostate cancer (PCa) managed through active surveillance (AS) ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0738399125006792

Effectiveness in physical activity levels of Proactive ... The results of this study indicated a significant improvement in physical activity levels of prostate cancer survivors after implementing ...

3. jamanetwork.com jamanetwork.com/journals/jamaoncology/article-abstract/2821208

Exercise for Prostate Cancer—Worthy Goals but ... The panel concluded that exercise interventions during cancer treatment reduced fatigue, enhanced quality of life, and improved physical function.

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/28169575/

A Clinician Referral and 12-Week Exercise Training ... ... exercise training program increased vigorous physical activity at 12 weeks among men with prostate cancer. Here, we report the 6- and 12-month outcomes.

5. nature.com nature.com/articles/s41391-021-00406-4

Exercise medicine in men with prostate cancer Exercise intervention studies in men with prostate cancer have shown well documented improvements in objective and self-reported outcomes [1] ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40540036/

Comparing aerobic and resistance exercise emphasis ... This study aimed to determine the feasibility of an aerobic-emphasised (AE) versus a resistance-emphasised (RE) exercise intervention in men with prostate ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0305737225001185

Exercise in patients with metastatic prostate cancer Physical activity improves quality of life in PC patients. · Exercise counters ADT side effects like fatigue and bone loss. · Exercise boosts immune response ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT04500080

Feasibility and Safety of Physical Exercise in Men With ... However, both therapies are associated with significant side effects, such as fatigue, loss of muscle mass and strength, cognitive decline that together lead to ...