What side effects are associated with this type of intervention?

Common treatments for prostate cancer include surgery, radiation therapy, hormone therapy, and chemotherapy. These treatments can have various side effects such as urinary incontinence, erectile dysfunction, bowel problems, fatigue, and hot flashes. In contrast, exercise therapy, like the regular home-based walking sessions on a treadmill studied in the trial, generally has fewer and milder side effects. Potential side effects of exercise therapy may include musculoskeletal injuries, such as strains or sprains, and rare serious medical events like arrhythmia or myocardial infarction. However, these risks are generally low, and the benefits of improved physical function and quality of life often outweigh the potential side effects.

What prior FDA approvals exist?

FDA-approved treatments for prostate cancer include androgen deprivation therapy (ADT), abiraterone, and enzalutamide, which are used for advanced, recurrent, and metastatic stages of the disease. These treatments have shown significant benefits in overall survival and failure-free survival in clinical trials. While exercise therapy, such as regular home-based walking sessions on a treadmill, is being studied for its potential benefits in low-risk prostate cancer patients on active surveillance, it is not a treatment modality that has received FDA approval specifically for prostate cancer management.

What other types of research exist?

Promising, novel alternatives to regular home-based walking sessions on a treadmill for prostate cancer patients could include: 1) High-Intensity Interval Training (HIIT), which has shown benefits in other cancer types and may offer similar advantages for prostate cancer. 2) Resistance training, which can improve muscle strength and overall physical health. 3) Mindfulness-based stress reduction programs, which can help manage stress and improve quality of life. 4) Telehealth systems to enhance adherence to home exercise programs, providing remote support and monitoring.

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Exercise Therapy for Prostate Cancer

Phase 2

Recruiting

Led By Lee Jones, PhD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6-12 months

Awards & highlights

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial involves exercise therapy rather than medication, side effects may include typical physical activity-related issues such as muscle soreness, fatigue, joint pain or injury risk. However, these are generally mild and manageable.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6-12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6-12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6-12 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

Change in molecular, radiologic, and pathologic nimbosus hallmarks from baseline to follow-up

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Participants Assigned to Exercise TherapyExperimental Treatment1 Intervention

Participants with histologically confirmed localized prostate cancer undergoing active surveillance

Group II: Participants Assigned to Usual CareActive Control1 Intervention

Participants with histologically confirmed localized prostate cancer undergoing active surveillance

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Exercise Therapy

2013

Completed Phase 3

~750

Do I qualify?Apply below to find out

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 surgery (removal of the prostate gland), radiation therapy (using high-energy rays to kill cancer cells), hormone therapy (reducing or blocking the production of testosterone which fuels cancer growth), chemotherapy (using drugs to kill rapidly dividing cells), and immunotherapy (boosting the immune system to fight cancer). Exercise therapy, such as regular home-based walking sessions on a treadmill, can be beneficial for prostate cancer patients by improving physical fitness, reducing fatigue, and potentially enhancing the body's ability to tolerate and respond to other treatments. This holistic approach can improve overall quality of life and may positively impact cancer outcomes.

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Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,956 Previous Clinical Trials

595,454 Total Patients Enrolled

133 Trials studying Prostate Cancer

51,526 Patients Enrolled for Prostate Cancer

Lee Jones, PhDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

7 Previous Clinical Trials

5,439 Total Patients Enrolled

1 Trials studying Prostate Cancer

70 Patients Enrolled for Prostate Cancer

Media Library

Exercise Therapy Clinical Trial Eligibility Overview. Trial Name: NCT05751434 — Phase 2

Prostate Cancer Research Study Groups: Participants Assigned to Usual Care, Participants Assigned to Exercise Therapy

Prostate Cancer Clinical Trial 2023: Exercise Therapy Highlights & Side Effects. Trial Name: NCT05751434 — Phase 2

Exercise Therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT05751434 — Phase 2

~59 spots leftby Feb 2027

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