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

Trial Summary

What is the purpose of this trial?

The purpose of this study is to determine whether a 16-week supervised, clinic-based circuit training intervention utilizing resistance and functional exercises and self-directed aerobic exercise will improve frailty and sarcopenic status and disease progression outcomes among pre-frail/frail metastatic prostate cancer patients receiving androgen deprivation therapy (ADT). The names of the study intervention involved in this study is: • Supervised circuit training (aerobic and resistance exercise regimen)

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 data supports the effectiveness of the treatment Supervised Circuit Training, Exercise Therapy, Physical Therapy, Rehabilitation Exercise for prostate cancer?

Research shows that exercise, including resistance and endurance training, can improve quality of life, muscle strength, and cardiovascular health in prostate cancer patients, especially those undergoing androgen-deprivation therapy. These exercises help manage treatment side effects like muscle loss and depression, and may also slow disease progression. ^{1 2 3 4 5}

Is exercise safe for prostate cancer patients?

Exercise, including resistance and endurance training, is generally safe for prostate cancer patients, even those undergoing androgen deprivation therapy, and can help manage treatment side effects like muscle loss and cardiovascular issues. ^{1 2 6 7 8}

How is the Supervised Circuit Training treatment for prostate cancer different from other treatments?

Supervised Circuit Training is unique because it focuses on improving physical function and quality of life through a combination of endurance and resistance exercises, even for prostate cancer patients with bone metastases, who are often excluded from exercise programs due to fracture risks. This approach helps counteract muscle loss and functional impairments caused by androgen deprivation therapy and other cancer treatments. ^{2 6 9 10 11}

Research Team

Christina M Dieli-Conwright, PhD

Principal Investigator

Dana-Farber Cancer Institute

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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 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]

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]

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]

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]

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 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 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]

References

1. Germany 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. [2022]

2. Belgium pubmed.ncbi.nlm.nih.gov

[Evaluation of a supervised six-month exercise program in patients with prostate cancer receiving androgen-deprivation therapy]. [2019]

3. Germany 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. [2021]

4. United States 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. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

What Should We Tell Patients About Physical Activity After a Prostate Cancer Diagnosis? [2020]

6. England 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. [2022]

7. Germany 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. [2021]

8. England 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. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Fitness outcomes from a randomised controlled trial of exercise training for men with prostate cancer: the ENGAGE study. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Attention to the principles of exercise training in exercise studies on prostate cancer survivors: a systematic review. [2020]

11. United States pubmed.ncbi.nlm.nih.gov

Exercise Preserves Physical Function in Prostate Cancer Patients with Bone Metastases. [2022]