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 explores whether a 16-week exercise program can help Black men with prostate cancer improve heart health, physical fitness, and overall well-being. Participants will either engage in aerobic and resistance exercises (exercise therapy) or continue their usual routine. It is ideal for Black men who have been on androgen deprivation therapy (a hormone treatment) for at least a month, do less than an hour of structured exercise per week, and can visit the Dana-Farber Cancer Institute for data collection. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance health outcomes for Black men with prostate cancer.

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.

What prior data suggests that this exercise intervention is safe for Black men with prostate cancer undergoing ADT?

Research has shown that aerobic and resistance exercises are generally safe for people with prostate cancer. Studies have found that exercise can help lessen the side effects of prostate cancer treatments, such as androgen deprivation therapy (ADT). Existing research indicates that exercise is well-tolerated, with few negative effects reported.

Beyond safety, exercise offers many benefits. It can improve body composition by balancing muscle and fat. Exercise also boosts physical fitness, enhances quality of life, and may reduce cancer symptoms.

Overall, evidence suggests that aerobic and resistance exercises are safe and beneficial for those receiving treatment for prostate cancer. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this exercise program for prostate cancer because it offers a unique, holistic approach to treatment. Unlike standard treatments such as surgery, radiation, or hormone therapy, which directly target cancer cells, this program focuses on improving overall health and quality of life through regular, virtually supervised aerobic and resistance exercises. The innovative home-based delivery method via Zoom allows patients to conveniently participate from their homes, encouraging consistent physical activity with professional guidance. This trial aims to demonstrate that such lifestyle interventions can be a valuable complement to traditional treatments, potentially enhancing outcomes and patient well-being.

What evidence suggests that aerobic and resistance exercise is effective for improving cardiovascular risk factors in Black men with prostate cancer undergoing ADT?

Research has shown that combining aerobic and resistance exercises, which participants in this trial may receive, can greatly improve the quality of life for men with prostate cancer. Studies have found that exercise can reduce cancer severity and may slow tumor growth and spread. It also enhances mental clarity, overall health, and sexual health. Additionally, exercise has improved erectile function in men with prostate cancer. Overall, exercise offers a promising way to address some challenges faced during prostate cancer treatment. ^{2 6 7 8 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.

Currently participate in less than or equal to 60 minutes of moderate or vigorous structured exercise per week

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

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]

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 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]

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]

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]

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]

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]

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]

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