Exercise Program for Prostate Cancer

Recruiting at 2 trial locations

Overseen By Christina M Dieli-Conwright, PhD

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Dana-Farber Cancer Institute

Must be taking: Androgen deprivation

Must not be taking: Chemotherapy

Disqualifiers: Unstable bone lesions, other malignancies, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 16 weeks

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a 16-week supervised exercise program can help men with prostate cancer who feel frail due to their treatment. The focus is on improving strength and reducing disease progression for those undergoing androgen deprivation therapy, a common prostate cancer treatment. Participants will either join a supervised exercise group (Supervised Circuit Training) or continue their normal activities to compare results. Ideal candidates are those with metastatic prostate cancer who have experienced frailty and do not currently engage in regular exercise. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance the quality of life for prostate cancer patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you must be on androgen deprivation therapy and cannot be receiving chemotherapy or treatment for other active cancers, except for basal cell carcinoma.

What prior data suggests that this exercise program is safe for prostate cancer patients?

Research shows that supervised exercise programs are generally safe and well-tolerated by participants. Studies have demonstrated that these programs can enhance the quality of life for people with prostate cancer. For example, one study found that a supervised exercise program helped reduce side effects from androgen deprivation therapy (ADT), a common prostate cancer treatment.

Another study compared exercises done at home with those done in supervised groups and found both methods effective and manageable for participants. This indicates that supervised exercises, like those in this trial, have been safely used in similar situations.

Overall, evidence suggests that supervised exercise is a safe option for most people, with no major negative effects reported in the studies reviewed. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the supervised circuit training program for prostate cancer because it offers a non-invasive approach that could complement existing treatments like surgery, radiation, or hormone therapy. Unlike traditional treatments that directly target cancer cells, this exercise regimen focuses on improving overall physical health, which may help patients better tolerate cancer treatments and improve their quality of life. The program's unique feature is its structured and supervised environment, ensuring participants engage safely and effectively, potentially leading to improved outcomes and reduced treatment side effects.

What evidence suggests that this exercise program is effective for prostate cancer?

Research has shown that supervised exercise can greatly improve the quality of life for people with prostate cancer. In this trial, participants in the Exercise Group will engage in a 16-week supervised exercise program. Studies indicate that regular, supervised exercise benefits quality of life more than not exercising at all. Exercise programs have successfully prevented weight gain, lowered blood pressure, and enhanced physical abilities in cancer patients. Additionally, high-intensity interval training (HIIT) has helped slow cancer cell growth and reduce prostate-specific antigen (PSA) levels, indicators of prostate cancer. These findings suggest that a supervised exercise program may offer significant benefits for those receiving treatment for advanced prostate cancer. ^{1 2 3 6 7}

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?

The FIERCE Trial is for English-speaking men over 18 with metastatic prostate cancer who are pre-frail or frail and on ADT. They must be willing to travel to Dana-Farber Cancer Institute, have physician clearance for exercise, and not already doing much structured exercise.

Inclusion Criteria

Have physician's clearance to participate in exercise

Willing to travel to Dana-Farber Cancer Institute for necessary data collection and exercise sessions

I have been diagnosed with prostate cancer that has spread.

Exclusion Criteria

You have been doing specific resistance exercises at least twice a week and moderate-to-intense aerobic exercises for at least an hour a week. Doing too much extra exercise could make it hard to see the effects of the study exercise program.

I am currently undergoing chemotherapy for issues related to androgen deprivation therapy.

I have bone lesions that are at high risk of fractures.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants partake in a 16-week supervised exercise program or continue with normal activities

16 weeks

Weekly supervised exercise sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Supervised Circuit Training

Trial Overview This study tests a 16-week supervised circuit training program combining resistance and functional exercises with self-directed aerobic activity. It aims to see if this can improve frailty, sarcopenia (muscle loss), and disease progression in patients.

How Is the Trial Designed?

Group I: Exercise Group Experimental Treatment 1 Intervention

Participants will partake in a 16-week supervised exercise program.

Group II: Attention Control Group Experimental Treatment 1 Intervention

Participants will continue with their normal daily activities.

Who Is Running the Clinical Trial?

Dana-Farber Cancer Institute

Lead Sponsor

Trials

1,128

Recruited

382,000+

Prostate Cancer Foundation

Collaborator

Trials

52

Recruited

3,000+

Published Research Related to This Trial

Exercise is strongly supported as an effective strategy to manage several adverse effects of androgen deprivation therapy (ADT) in prostate cancer patients, including loss of muscle mass, fatigue, and declining physical function.

In addition to physical benefits, exercise may also improve mental health outcomes such as depression and anxiety, suggesting it plays a crucial role in enhancing overall quality of life and survivorship for men undergoing ADT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of exercise in the management of adverse effects of androgen deprivation therapy for prostate cancer: a rapid review. Edmunds, K., Tuffaha, H., Scuffham, P., et al.[2021]

This study aims to evaluate the safety and efficacy of a 3-month modular multi-modal exercise program for 90 prostate cancer survivors with bone metastases, addressing concerns about muscle atrophy and functional impairments due to prior treatments.

The exercise program is designed to be safe for patients with bone metastases, potentially improving physical function and delaying skeletal complications, which could significantly enhance the quality of life for these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of a modular multi-modal exercise program in prostate cancer patients with bone metastases: a randomized controlled trial. Galvão, DA., Taaffe, DR., Cormie, P., et al.[2022]

The 'Football Club (FC) Prostate' study is a randomized trial involving 80 men undergoing androgen deprivation therapy (ADT) for advanced prostate cancer, aiming to evaluate the effects of soccer training on various health outcomes over a 12-week period.

The primary focus is on changes in lean body mass, with secondary outcomes including cardiovascular function and patient-reported quality of life, potentially demonstrating that soccer training can be a safe and effective rehabilitation strategy for men receiving ADT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of recreational soccer in men with prostate cancer undergoing androgen deprivation therapy: study protocol for the 'FC Prostate' randomized controlled trial. Uth, J., Schmidt, JF., Christensen, JF., et al.[2021]

A 12-week community-based exercise program significantly improved physical fitness and strength in 119 men with prostate cancer, including enhancements in walking distance, leg and chest strength, and overall physical function compared to a control group.

The study found that androgen deprivation therapy (ADT) did not affect the positive responses to exercise training, suggesting that exercise benefits men with prostate cancer regardless of their treatment status.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fitness outcomes from a randomised controlled trial of exercise training for men with prostate cancer: the ENGAGE study. Gaskin, CJ., Fraser, SF., Owen, PJ., 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 exercise trials in prostate cancer survivors found that while 93% of studies applied the principle of specificity in exercise programming, other key principles like progression and overload were less frequently applied, indicating potential inadequacies in exercise stimulus.

Although 79% of studies reported the components of the exercise prescription, none fully reported participant adherence to the prescribed programs, highlighting a gap that could hinder understanding the optimal exercise dose for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Attention to the principles of exercise training in exercise studies on prostate cancer survivors: a systematic review. Neil-Sztramko, SE., Medysky, ME., Campbell, KL., et al.[2020]

A 10-month study involving 40 prostate cancer patients showed that a home-based progressive resistance exercise training program significantly improved aerobic capacity, upper and lower limb strength, and health-related quality of life compared to a control group that received usual care.

While the exercise program did not significantly affect brachial artery flow-mediated dilatation, it was deemed safe, with only five adverse events reported, indicating that it can be a beneficial addition to recovery after robot-assisted radical prostatectomy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Supported progressive resistance exercise training to counter the adverse side effects of robot-assisted radical prostatectomy: a randomised controlled trial. Ashton, RE., Aning, JJ., Tew, GA., et al.[2021]

A pilot randomized controlled trial involving 25 men with metastatic castrate-resistant prostate cancer (mCRPC) demonstrated that remotely monitored exercise training is feasible, safe, and acceptable, with 82% of participants completing the 12-week program.

Participants showed high adherence to the exercise regimen, completing 90% of aerobic and 96% of resistance training sessions, and reported high satisfaction with the program, indicating strong potential for future studies on exercise's impact on clinical outcomes in this patient group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility, safety, and acceptability of a remotely monitored exercise pilot CHAMP: A Clinical trial of High-intensity Aerobic and resistance exercise for Metastatic castrate-resistant Prostate cancer. Kenfield, SA., Van Blarigan, EL., Panchal, N., et al.[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]

A study involving 57 prostate cancer patients with bone metastases showed that a multimodal exercise program significantly improved self-reported physical functioning and lower body muscle strength after 3 months, compared to usual care.

The exercise program was safe, with no reported exercise-related adverse events or skeletal fractures, indicating that supervised exercise can be beneficial for patients with bone metastases without increasing the risk of complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise Preserves Physical Function in Prostate Cancer Patients with Bone Metastases. Galvão, DA., Taaffe, DR., Spry, N., 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9385477/

Supervised exercise therapy compared with no ... Evidence of moderate quality shows that supervised exercise therapy probably is superior to no exercise therapy in improving 'disease-specific quality of life' ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1879406823002436

Home-based versus supervised group exercise in men ... A HOME exercise intervention appears non-inferior to GROUP for fatigue and functional endurance and requires fewer resources to implement.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9524100/

Effects of supervised high-intensity interval training on ... Men with prostate cancer on active surveillance were largely motivated and expected significant benefits from a supervised HIIT program.

4. ej-med.org ej-med.org/index.php/ejmed/article/view/2231

Effectiveness of Exercise Therapy for Patients with Prostate ... Recent studies have demonstrated that HIIT effectively improves cancer cell growth inhibition and decreases prostate-specific antigen levels in ...

5. ascopubs.org ascopubs.org/doi/10.1200/OP.21.00745

Nationwide Industry-Led Community Exercise Program for ... The community exercise program was feasible and effective in preventing weight gain, reducing blood pressure, and improving physical function in patients with ...

6. ascopubs.org ascopubs.org/doi/10.1200/GO.2023.9.Supplement_1.71

Effects of supervised exercise and self-managed ... Effects of supervised exercise and self-managed psychosexual therapy on sexual health in men with prostate cancer: A randomized clinical trial.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6051362/

Effects of a six-month supervised physical exercise ... This pilot study demonstrated that a supervised physical exercise program can reduce several androgen deprivation therapy-related side effects, improving ...