Exercise for Prostate Cancer

Overseen By Christina M Dieli-Conwright, PhD

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Dana-Farber Cancer Institute

Must be taking: Androgen deprivation therapy

Disqualifiers: Uncontrolled cardiopulmonary, Metabolic diseases, others

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

Compensation: Varies

Number of Visits: 5

Duration: 16 weeks

62 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests if a home-based exercise program can improve heart health and overall well-being in Black men with prostate cancer undergoing hormone therapy. Participants will do supervised aerobic and resistance exercises several times a week. A combined aerobic and resistance exercise program over several months has shown significant benefits in heart and metabolic health in prostate cancer patients undergoing hormone therapy.

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

The trial does not specify if you need to stop taking your current medications. However, you must continue your androgen deprivation therapy (ADT) during the study.

Is exercise safe for people with prostate cancer?

Exercise, including aerobic and resistance training, is generally safe for people with prostate cancer and can improve cardiovascular fitness, muscle strength, and mental health. It is also effective in reducing some treatment-related side effects, such as high blood pressure and poor physical function. ^{1 2 3 4 5}

How does exercise therapy differ from other treatments for prostate cancer?

Exercise therapy for prostate cancer is unique because it involves physical activity, such as aerobic and resistance exercises, which can improve overall survival, reduce side effects of cancer treatments, and enhance quality of life. Unlike traditional drug treatments, it focuses on improving physical fitness and reducing the negative impacts of inactivity and hormonal treatments. ^{3 4 6 7 8}

What data supports the effectiveness of the treatment involving aerobic and resistance exercise for prostate cancer?

Research shows that exercise, including both aerobic and resistance types, can improve physical performance, quality of life, and reduce side effects like high blood pressure and depression in prostate cancer patients undergoing hormone therapy. Additionally, exercise may help improve survival rates in advanced prostate cancer cases. ^{2 3 4 6 9}

Who Is on the Research Team?

Christina M Dieli-Conwright, PhD

Principal Investigator

Dana-Farber Cancer Institute

Are You a Good Fit for This Trial?

This trial is for Black men over 18 with prostate cancer, undergoing androgen deprivation therapy, who exercise less than or equal to 60 minutes per week. They must be able to travel to DFCI for data collection, speak English/Spanish, and have medical clearance to exercise. Excluded are those not on ADT, unable to meet study requirements or with certain medical conditions.

Inclusion Criteria

Self-identify as Black

I am over 18 years old.

I have been on hormone therapy for prostate cancer for at least a month and plan to continue.

Exclusion Criteria

I have another diagnosis besides basal cell carcinoma.

I am not on hormone therapy for cancer.

Unable to travel to DFCI for necessary data collection

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants are randomly assigned to either a 16-week virtually supervised aerobic and resistance exercise program or usual care

16 weeks

2 visits (in-person), weekly virtual sessions

Mid-study Assessment

Exercise group undergoes additional testing at week 8 to assess aerobic fitness and muscular strength

1 week

1 visit (in-person)

Follow-up

Participants are monitored for cardiovascular risk factors, physical fitness, and other health outcomes

4 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Aerobic and resistance exercise
• Usual Care

Trial Overview The study tests if a 16-week program of culturally tailored aerobic and resistance exercises can improve cardiovascular health in Black prostate cancer patients on ADT compared to usual care without structured exercise. Participants will be randomly placed into one of these two groups.

How Is the Trial Designed?

Group I: Aerobic and resistance exercise Experimental Treatment 1 Intervention

Virtually supervised 16-week aerobic and resistance exercise performed at home via Zoom. The exercises will be performed three times per week for 16 weeks, and virtually supervised by a professional exercise trainer.

Group II: Usual care Active Control 1 Intervention

Maintenance of baseline exercise levels for 16 weeks with an offer to perform the same exercise program after 16 weeks.

Who Is Running the Clinical Trial?

Dana-Farber Cancer Institute

Lead Sponsor

Trials

1,128

Recruited

382,000+

Pfizer

Industry Sponsor

Trials

4,712

Recruited

50,980,000+

Known For

Vaccine Innovations

Top Products

Viagra, Zoloft, Lipitor, Prevnar 13

Albert Bourla

Pfizer

Chief Executive Officer since 2019

PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki

Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University

Prostate Cancer Foundation

Collaborator

Trials

52

Recruited

3,000+

Published Research Related to This Trial

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 6-month feasibility trial involving 24 prostate cancer patients undergoing androgen deprivation therapy (ADT) aims to compare the effects of resistance vs. aerobic exercise on cardiometabolic health and quality of life.

The study will assess various outcomes including recruitment, retention, adherence, and safety, which will help inform the design of a larger trial focused on optimizing exercise interventions for patients on ADT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comparison of aerobic- and resistance-emphasised exercise on cardiometabolic health and quality of life in men receiving androgen deprivation therapy for prostate cancer: Protocol for a feasibility trial. Murphy, K., Kehoe, B., Denieffe, S., et al.[2023]

Resistance exercise (RE) significantly improves body composition and physical function in prostate cancer patients, with notable increases in lean body mass and appendicular skeletal mass, as well as enhanced leg press strength and stair climbing ability.

Starting RE immediately after androgen deprivation therapy (ADT) and maintaining the exercise for at least 6 months leads to greater improvements, especially when performed at an intensity of 8-12 repetitions maximum (RM).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of resistance exercise on body composition and physical function in prostate cancer patients undergoing androgen deprivation therapy: an update systematic review and meta-analysis. Tian, S., Ding, M., Sun, H.[2022]

This phase III randomized controlled trial involves 866 participants with metastatic castrate-resistant prostate cancer (mCRPC) to assess whether supervised high-intensity aerobic and resistance exercise can improve overall survival compared to self-directed exercise.

The study will also explore the relationship between exercise and various health factors, such as immune function and metabolic biomarkers, which may help understand how exercise impacts survival outcomes in mCRPC patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intense Exercise for Survival among Men with Metastatic Castrate-Resistant Prostate Cancer (INTERVAL-GAP4): a multicentre, randomised, controlled phase III study protocol. Newton, RU., Kenfield, SA., Hart, NH., 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]

A systematic review of 21 trials involving 1748 prostate cancer patients found that resistance exercise significantly improved body composition, functional capacity, and muscle strength, with a notable reduction in fat mass and an increase in lean mass.

The study suggests that lower volume resistance training at moderate to high intensity is just as effective as higher volume training, which may help make exercise more accessible and encourage adherence among patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Resistance Exercise Dosage in Men with Prostate Cancer: Systematic Review, Meta-analysis, and Meta-regression. Lopez, P., Taaffe, DR., Newton, RU., et al.[2023]

A systematic review of 33 randomized controlled trials involving 2567 participants found that exercise has a small positive effect on cancer-specific quality of life (QoL) in men with prostate cancer, but the effect is not strongly influenced by the type of exercise performed.

Aerobic exercise was particularly effective in improving cardiovascular fitness (moderate to large effect) and had significant benefits on lower body strength, mental health, and blood pressure, highlighting its importance in enhancing metabolic health for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Do Patients with Prostate Cancer Benefit from Exercise Interventions? A Systematic Review and Meta-Analysis. Andersen, MF., Midtgaard, J., Bjerre, ED.[2022]

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]

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]

Citations

1. 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]

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

A comparison of aerobic- and resistance-emphasised exercise on cardiometabolic health and quality of life in men receiving androgen deprivation therapy for prostate cancer: Protocol for a feasibility trial. [2023]

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

The effects of resistance exercise on body composition and physical function in prostate cancer patients undergoing androgen deprivation therapy: an update systematic review and meta-analysis. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Intense Exercise for Survival among Men with Metastatic Castrate-Resistant Prostate Cancer (INTERVAL-GAP4): a multicentre, randomised, controlled phase III study protocol. [2022]

5. Belgium pubmed.ncbi.nlm.nih.gov

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

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

Resistance Exercise Dosage in Men with Prostate Cancer: Systematic Review, Meta-analysis, and Meta-regression. [2023]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Do Patients with Prostate Cancer Benefit from Exercise Interventions? A Systematic Review and Meta-Analysis. [2022]

8. Hungary pubmed.ncbi.nlm.nih.gov

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

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

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