What side effects are associated with this type of intervention?

Common treatments for prostate cancer, such as androgen deprivation therapy (ADT), often lead to side effects including cardiovascular issues, bone density loss, muscle weakness, fatigue, and mental health impacts. The combination of ADT with other treatments like abiraterone can increase the risk of hypertension and hypokalemia. Structured aerobic and resistance exercise interventions are being studied to mitigate these side effects by enhancing cardiovascular health, physical fitness, and overall well-being.

What prior FDA approvals exist?

The FDA has approved several treatments for prostate cancer that aim to manage symptoms and improve quality of life. Notably, androgen deprivation therapy (ADT) is a common treatment that reduces androgen levels to slow cancer growth. Drugs like abiraterone, often used in combination with ADT, have shown significant benefits in extending survival and managing symptoms. Additionally, the STAMPEDE trial demonstrated the efficacy of combining ADT with abiraterone and prednisolone, resulting in improved overall and failure-free survival. These treatments, while pharmacological, share the goal of enhancing patient well-being, similar to the benefits observed with structured aerobic and resistance exercise interventions.

What other types of research exist?

Promising novel alternatives to aerobic and resistance exercise for prostate cancer patients include: 1) Technology-based interventions such as virtual reality exercise programs, which can provide engaging and tailored physical activity experiences. 2) Mind-body exercises like yoga and tai chi, which have been shown to improve physical fitness, reduce stress, and enhance overall well-being. 3) Aquatic therapy, which offers low-impact exercise options that can improve cardiovascular health and physical fitness without putting stress on the joints.

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Exercise for Prostate Cancer

N/A

Recruiting

Led By Christina C Dieli-Conwright, PhD, MPH

Research Sponsored by Dana-Farber Cancer Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Over 18 years old; children under the age of 18 will be excluded due to the rarity of the disease

Have been receiving androgen deprivation therapy (ADT) for at least one month with a plan to continue ADT for at least 4 months at the time of recruitment

Must not have

Are not receiving ADT

Are not English or Spanish speaking

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 4 months

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While the trial itself does not involve medication that would cause side effects, participants may experience typical physical responses related to new exercise routines such as muscle soreness or fatigue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am over 18 years old.

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

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I have been diagnosed with prostate cancer, either localized or spread.

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I don't have health issues worsened by exercise like severe bone disease or uncontrolled heart/lung problems.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not on hormone therapy for cancer.

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I do not speak English or Spanish.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 4 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to 4 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 4 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Cardiovascular Diseases

Secondary study objectives

Cancer treatment symptoms - MDASI

Cardiorespiratory capacity

Fat mass

+12 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Aerobic and resistance exerciseExperimental Treatment1 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 careActive Control1 Intervention

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

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for prostate cancer include androgen deprivation therapy (ADT) and structured physical activity such as aerobic and resistance exercise. ADT works by reducing the levels of androgens, which are hormones that can stimulate the growth of prostate cancer cells. This therapy helps to slow down or shrink the cancer. On the other hand, aerobic and resistance exercise improves cardiovascular health, physical fitness, and overall well-being. Exercise helps to mitigate some of the side effects of ADT, such as weight gain, loss of muscle mass, and decreased bone density, thereby enhancing the quality of life for prostate cancer patients. These combined approaches are crucial as they not only target the cancer cells but also support the patient's overall health and functional status.