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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a home exercise program, known as the Exercise Training Intervention, can improve fitness in prostate cancer patients. It compares two groups: one engaging in tailored exercises and another receiving education on healthy living. Men with stage II, III, or IV prostate cancer undergoing hormone therapy may be suitable candidates, particularly if they can participate via computer or phone. Participants should be willing and able to safely engage in exercise activities. As a Phase 1, Phase 2 trial, this research seeks to understand how the treatment works in people and measure its effectiveness in an initial, smaller group, offering participants a chance to contribute to early-stage research.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that exercise is generally safe and well-tolerated for men with prostate cancer. One study found that home-based exercise programs improved physical abilities and quality of life while being easy for patients to follow. This indicates that patients can safely perform these exercises at home. Another study demonstrated that exercise might reduce cancer severity and slow tumor growth, supporting the idea that exercise is a safe way to help manage prostate cancer. Overall, these findings suggest that exercise is a safe option for prostate cancer patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Exercise Training Intervention for prostate cancer because it's a non-drug approach that focuses on improving physical fitness and overall health. Unlike standard treatments like surgery, radiation, or hormone therapy, this method tailors an exercise program to each participant's fitness level, aiming to enhance cardiorespiratory fitness and strength. By encouraging at least 150 minutes of moderate to vigorous physical activity per week, this intervention could improve quality of life and potentially impact cancer progression without the side effects associated with traditional treatments.

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

This trial will compare an Exercise Training Intervention with a Healthy Living Education Control for men with prostate cancer. Research has shown that exercise greatly benefits men with prostate cancer. Studies have found that exercise boosts energy levels and reduces tiredness. Home-based exercise proves just as effective as group exercise. Exercise might also support the immune system and slow cancer growth. Additionally, it can help manage side effects from prostate cancer treatments, such as changes in body shape. Overall, exercise appears to be a promising way to support health in men with prostate cancer. ^{1 6 7 8 9}

Who Is on the Research Team?

Alexander R Lucas, PhD

Principal Investigator

Virginia Commonwealth University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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]

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 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 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]

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]

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 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 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 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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37976654/

Home-based versus supervised group exercise in men ... There was an 89.8% probability that HOME was non-inferior to GROUP for both fatigue and functional endurance and a 9.5% probability that HOME reduced fatigue ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07126860

The Effect of a Structured Strength and Endurance Training ... Some studies even suggest that exercise might support the immune system and slow down the progression of cancer. The aim of this clinical trial ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10319656/

Feasibility of home-based exercise training during adjuvant ... Exercise is an effective adjuvant therapy that can alleviate treatment-related toxicities for men with prostate cancer (PC).

4. nature.com nature.com/articles/s41391-021-00450-0

a systematic review and meta-analysis | Prostate Cancer ... Evidence of moderate quality shows that supervised exercise therapy probably is superior to no exercise therapy in improving 'disease-specific quality of life' ...

5. 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.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7554354/

A randomized controlled trial of a home-based exercise ... A 24-week home-based exercise program that can improve prognosis, physical function, and quality of life (QoL) in men with prostate cancer (PCa).

7. sciencedirect.com sciencedirect.com/science/article/pii/S2950273X24000547

Effects of exercise training on prostate cancer Exercise has emerged as a promising strategy, with evidence suggesting its efficacy in reducing cancer severity, inhibiting tumor progression and metastasis.

8. clinicaltrials.gov clinicaltrials.gov/study/NCT05258526

Home Based Exercise for Patients With Breast or Prostate ... The purpose of this trial is to evaluate the feasibility of a home based exercise program for individuals with breast or prostate cancer patients undergoing ...

9. nature.com nature.com/articles/s41598-018-26682-0

Exercise training as a novel primary treatment for localised ... Observational data has suggested that physical activity could improve prostate cancer–specific mortality and overall mortality. Few clinical ...