Exercise for Prostate Cancer

Overseen By Rana Sullivan, RN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Must be taking: Androgen deprivation therapy

Disqualifiers: Small cell carcinoma, Impaired cognition, Bone pain, others

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

Compensation: Varies

Number of Visits: 3

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if exercise can reduce the number of cancer cells in the blood for men with advanced prostate cancer. Participants will follow a guided exercise program for 12 weeks and track their activities. The trial targets men with metastatic prostate cancer who are on specific medications and have a rising PSA, a marker of prostate health.

As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research on exercise and cancer management.

Will I have to stop taking my current medications?

The trial does not require you to stop your current medications. In fact, you need to be on androgen deprivation therapy or an oral androgen axis inhibitor for at least 3 months to participate.

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

In a previous study, experts found that exercise during cancer treatment reduced tiredness and improved quality of life. Another study showed that physical activity lowered the risk of dying from prostate cancer by 30%. Exercise also improved physical abilities.

No evidence suggests that exercise negatively affects prostate cancer patients. Instead, staying active might reduce the risk of the cancer worsening. Therefore, the exercise treatment in this trial is likely safe and could benefit those with advanced prostate cancer. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional treatments for prostate cancer, such as surgery, radiation, and hormone therapy, the exercise intervention is unique because it focuses on enhancing the patient's physical activity as a form of therapy. This approach is exciting because it aims to improve overall health and potentially mitigate some side effects of conventional treatments, like fatigue and muscle loss. By personalizing an exercise program and adjusting it over time, researchers hope to show that staying active can positively impact the well-being of prostate cancer patients.

What evidence suggests that exercise intervention is effective for reducing circulating tumor cells in advanced prostate cancer?

Research has shown that regular exercise greatly benefits men with prostate cancer. In this trial, participants will follow a prescribed exercise program for 12 weeks. Studies have found that active prostate cancer survivors have a 30–60% lower risk of dying from the disease. Exercise also improves erectile function compared to those who do not exercise. Additionally, exercise can reduce the side effects of treatments like androgen deprivation therapy, which often alters body shape. Overall, exercise consistently links to better health outcomes for men with prostate cancer. ^{5 6 7 8 9}

Who Is on the Research Team?

Cathy Marshall, MD

Principal Investigator

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Are You a Good Fit for This Trial?

Men under 80 with advanced prostate cancer, currently on androgen deprivation therapy for at least 3 months, can join this trial. They should have circulating tumor cells (CTC) present, an ECOG performance status of 0 or 1, and if seeing a cardiologist, must be cleared to participate. Prior treatments are allowed.

Inclusion Criteria

I am 80 years old or younger.

I have been on hormone therapy for prostate cancer for at least 3 months.

Elevated (PSA > 1ng/mL) or rising PSA based on at least 2 readings at least 2 weeks apart

Exclusion Criteria

My condition is worsening and needs a new treatment plan or added radiation for symptom relief.

Unable to participate or monitor exercise compliance due to impaired cognition

I have a heart condition or other illness that makes exercising unsafe.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Exercise Intervention

Participants adhere to a prescribed exercise program for 12 weeks, with assessments and adjustments at Week 5 and Week 9

12 weeks

3 visits (in-person)

Follow-up

Participants undergo follow-up assessments 12 weeks after the exercise intervention and are monitored for vital status for 365 days

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Exercise Intervention

Trial Overview The study is testing how regular exercise affects the number of circulating tumor cells in men with advanced prostate cancer over a period of 12 weeks. Participants will undergo initial assessments, follow the exercise program for three months, then have follow-up evaluations.

How Is the Trial Designed?

Group I: Exercise Intervention Experimental Treatment 1 Intervention

Participants will be prescribed an exercise program after completing assessments at baseline. Participants will adhere to the prescribed exercise intervention for 12 weeks and log activity in a physical activity diary. Participants will return to clinic on Week 5 and Week 9 for assessments and adjustment to their exercise prescription as needed.

Who Is Running the Clinical Trial?

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Lead Sponsor

Trials

578

Recruited

33,600+

Physical Medicine & Rehabilitation Educ Research Foundation, Inc

Collaborator

Trials

1

Recruited

20+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12181210/

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 ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2405456923000640

Exercise Interventions for Men with Prostate Cancer Observational evidence suggests that prostate cancer survivors who are regularly physically active have a 30–60% lower risk of prostate cancer–specific ...

3. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2831323

Exercise and Psychosexual Education to Improve Sexual ... In this randomized clinical trial including 112 patients with prostate cancer, exercise improved erectile function compared with usual care.

4. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0263918

The effects of exercise on body composition of prostate cancer ... Exercise can help ameliorate the adverse effects of androgen deprivation therapy in body composition, with combination exercises including resistance exercise.

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

The Impact of Physical Activity on the Outcomes ... Some authors have found no correlation between engaging in physical exercise and the risk of tumor progression [24,25,27]. Specifically, two ...

7. 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.

8. nature.com nature.com/articles/s41391-022-00509-6

evidence that physical activity is beneficial for prostate cancer A recent systematic review and meta-analysis by Friedenreich et al. reported a 30% risk reduction for prostate cancer mortality and a 40% risk ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8377605/

Effects of Exercise on Cardiorespiratory Fitness and ... The data suggest that high-intensity aerobic exercise might be necessary to produce changes in biochemical outcomes in prostate cancer. Both ...