Exercise Training for Prostate Cancer

(EXTRA-PC Trial)

Recruiting at 1 trial location

Overseen By Alexandra Marshall, MS

Age: 18+

Sex: Male

Trial Phase: Phase 1 & 2

Sponsor: Virginia Commonwealth University

Must be taking: ADT

Disqualifiers: Cardiovascular disease, Heart failure, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

60 Participants Needed

Trial Summary

What is the purpose of this trial?

To test the preliminary effectiveness of a home-based exercise training (ET) intervention to improve exercise capacity (VO2 peak \& 6-minute walk distance \[6MWD\]) among prostate cancer (PC) patients compared to controls receiving healthy living education (HLE) at 12 weeks.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, since participants must be undergoing treatment with ADT (a type of prostate cancer therapy), it seems you may need to continue that specific medication.

What data supports the effectiveness of the treatment Exercise Training Intervention for prostate cancer?

Research shows that exercise can help reduce the side effects of prostate cancer treatments like androgen-deprivation therapy (ADT). Studies found that exercise improves body composition and mobility, and can be safely done at home, even for those with advanced prostate cancer. ^{1 2 3 4 5}

Is exercise training safe for men with prostate cancer?

Exercise training for men with prostate cancer, including those on androgen deprivation therapy, has been shown to be safe without serious adverse events, and it can help manage treatment side effects. ^{6 7 8 9 10}

How is the exercise training treatment for prostate cancer different from other treatments?

Exercise training for prostate cancer is unique because it is a non-drug treatment that can be done at home, making it more accessible and convenient. It focuses on improving quality of life and reducing side effects of other treatments, like hormone therapy, through physical activity. ^{3 4 5 8 11}

Research Team

Alexander R Lucas, PhD

Principal Investigator

Virginia Commonwealth University

Eligibility Criteria

This trial is for men aged 40-85 with stage II/III/IV prostate cancer, currently on ADT treatment, and who've completed curative-intent treatments like surgery or radiation. Participants must be able to use a computer or phone, speak English, and have no serious conditions that would make exercise unsafe.

Inclusion Criteria

I have been diagnosed with stage II, III, or IV prostate cancer.

I can participate in sessions using my computer, smartphone, or phone and agree to have my interview recorded.

I am currently on hormone therapy for cancer.

Exclusion Criteria

I cannot have an MRI due to metal in my body, inability to lie flat, or claustrophobia.

I have a known heart condition or heart failure.

My platelet count is less than 10 x 10^9/L.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a 12-week home-based exercise training intervention or receive healthy living education

12 weeks

Remote sessions and telephone calls

Follow-up

Participants are monitored for changes in exercise capacity and other health metrics

12 weeks

Treatment Details

Interventions

• Exercise Training Intervention
• Healthy Living Education

Trial Overview The study compares the effects of a home-based exercise training program against healthy living education in improving physical fitness of prostate cancer patients. The focus is on whether exercise can boost peak oxygen intake and walking distance after 12 weeks.

Participant Groups

Group I: Exercise Training Intervention Experimental Treatment 1 Intervention

The exercise program (ET) is tailored to each participant depending on his initial functional capacity, cardiorespiratory fitness and strength, to achieve ≥150 moderate to vigorous physical activity

Group II: Healthy Living Education Control Active Control 1 Intervention

Educational modules delivered remotely (or manual and telephone call) in a group-based setting to approximately match contact frequency and structure with the ET arm.

Exercise Training Intervention is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Exercise Training for:

• Cardiovascular Disease Risk Reduction
• Improvement of Exercise Capacity in Prostate Cancer Patients

Approved in European Union as Physical Training for:

• Cardiovascular Disease Prevention
• Rehabilitation and Improvement of Physical Fitness

Approved in Canada as Exercise Therapy for:

• Cardiovascular Health
• Physical Rehabilitation

Who Is Running the Clinical Trial?

Virginia Commonwealth University

Lead Sponsor

Trials

732

Recruited

22,900,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Findings from Research

A 3-month supervised exercise program for 50 prostate cancer patients starting androgen-deprivation therapy (ADT) significantly improved their quality of life and reduced cardiovascular risk, even after exercise was withdrawn.

While exercise training prevented declines in cardiopulmonary fitness and fatigue during the program, these benefits were not maintained after the program ended, highlighting the importance of ongoing physical activity for sustained health benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise-induced attenuation of treatment side-effects in patients with newly diagnosed prostate cancer beginning androgen-deprivation therapy: a randomised controlled trial. Ndjavera, W., Orange, ST., O'Doherty, AF., et al.[2020]

The EX+D (exercise and dietary) intervention significantly improved body composition in prostate cancer patients undergoing androgen deprivation therapy, showing reductions in fat mass and increases in lean mass compared to standard care.

Improvements in body composition from the EX+D intervention were associated with better mobility performance and strength, highlighting its potential benefits for physical function in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a lifestyle intervention on body composition in prostate cancer patients on androgen deprivation therapy. Chaplow, ZL., Focht, BC., Lucas, AR., et al.[2022]

The EXACT trial demonstrated that a 12-week home-based exercise program was feasible and safe for men with metastatic castrate-resistant prostate cancer (mCRPC), with a high retention rate of 79% and no adverse events reported during the intervention.

Participants experienced significant improvements in functional fitness and reductions in fatigue, indicating that exercise can positively impact health-related quality of life for patients undergoing treatment for mCRPC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of home-based exercise training during adjuvant treatment for metastatic castrate-resistant prostate cancer patients treated with an androgen receptor pathway inhibitor (EXACT). Brown, M., Murphy, MH., McAneney, H., et al.[2023]

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]

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]

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]

A supervised exercise training intervention integrated into standard prostate cancer care was feasible and well-accepted, with 79% of eligible participants (36 out of 45) receiving the intervention despite COVID-19 lockdowns.

Participants engaged in an average of 27 minutes of aerobic exercise per session, achieving 92% of their target heart rate, and completed the program without serious adverse events, indicating the safety and potential benefits of exercise in managing the side effects of androgen deprivation therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Embedding supervised exercise training for men on androgen deprivation therapy into standard prostate cancer care: a feasibility and acceptability study (the STAMINA trial). Reale, S., Turner, RR., Sutton, E., et al.[2021]

A 12-week home-based exercise program for men with metastatic castration-resistant prostate cancer (mCRPC) was found to be feasible, with a 47% recruitment rate and a 73% retention rate among participants.

The exercise intervention led to significant improvements in thigh muscle size and endurance, with a 22% increase in muscle cross-sectional area and a 19% increase in time to exhaustion, indicating potential benefits of home-based training during hormone therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of home-based exercise training in men with metastatic castration-resistant prostate cancer. Hanson, ED., Alzer, M., Carver, J., et al.[2023]

This pilot study will assess the feasibility and safety of a 20-week multicomponent exercise program for 25 men undergoing androgen deprivation therapy (ADT) and radiotherapy (RT) for prostate cancer, focusing on improving physical and cognitive functions as well as quality of life.

The primary outcomes include recruitment, adherence, and safety of the exercise intervention, while secondary outcomes will evaluate muscle strength, balance, fatigue, anxiety, depression, cognitive function, quality of life, and the incidence of falls and fractures during and after the intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and safety of physical exercise in men with prostate cancer receiving androgen deprivation therapy and radiotherapy: a study protocol. Bressi, B., Iotti, C., Cagliari, M., 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]

References

1. England pubmed.ncbi.nlm.nih.gov

Exercise-induced attenuation of treatment side-effects in patients with newly diagnosed prostate cancer beginning androgen-deprivation therapy: a randomised controlled trial. [2020]

2. Germany pubmed.ncbi.nlm.nih.gov

Effects of a lifestyle intervention on body composition in prostate cancer patients on androgen deprivation therapy. [2022]

3. Germany pubmed.ncbi.nlm.nih.gov

Feasibility of home-based exercise training during adjuvant treatment for metastatic castrate-resistant prostate cancer patients treated with an androgen receptor pathway inhibitor (EXACT). [2023]

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

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

6. 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]

7. England pubmed.ncbi.nlm.nih.gov

Embedding supervised exercise training for men on androgen deprivation therapy into standard prostate cancer care: a feasibility and acceptability study (the STAMINA trial). [2021]

8. England pubmed.ncbi.nlm.nih.gov

Feasibility of home-based exercise training in men with metastatic castration-resistant prostate cancer. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Feasibility and safety of physical exercise in men with prostate cancer receiving androgen deprivation therapy and radiotherapy: a study protocol. [2022]

10. Belgium pubmed.ncbi.nlm.nih.gov

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

11. England pubmed.ncbi.nlm.nih.gov

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