Exercise Training for Prostate Cancer

(BETR-PC Trial)

Overseen By Massey CTO CPC Team

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Virginia Commonwealth University

Must be taking: ADT

Disqualifiers: Hearing impairments, Sight impairments, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a remote exercise program specifically designed for people with prostate cancer. The goal is to determine if this exercise approach, known as Behavioral Exercise Training (BET), can help those undergoing hormone therapy (ADT) build healthy exercise habits. The trial uses a group setting to foster support and connection among participants. It suits men, transwomen, or non-binary individuals with stage II, III, or IV prostate cancer who are currently on hormone therapy and have completed surgery or radiation. Participants must be able to join group sessions online or by phone and should not have serious health issues that would make exercising unsafe. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could improve exercise habits for those on hormone therapy.

Will I have to stop taking my current medications?

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

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

Research shows that exercise is generally safe and beneficial for men with prostate cancer. One study found that even a small amount of exercise can lower the risk of cancer progression. Another study demonstrated that exercise can reduce cancer severity and slow tumor growth.

Specifically, a clinical trial found that remotely monitored exercise training was safe and well-received by men with advanced prostate cancer, with no major safety issues reported. Experts agree that exercise can reduce fatigue, improve quality of life, and enhance physical ability during cancer treatment.

Overall, these findings suggest that exercise programs are well-tolerated and safe for individuals with prostate cancer. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Behavioral Exercise Training (BET) for prostate cancer because it's a fresh approach focusing on lifestyle changes rather than medications or surgery. Unlike traditional treatments like hormone therapy, radiation, or surgery, BET emphasizes building behavioral skills to adopt a consistent exercise routine, which can enhance overall health and potentially improve cancer outcomes. This method also fosters social support and group cohesion, which is unique because it aims to create a supportive community among participants, making the lifestyle change more sustainable and enjoyable.

What evidence suggests that Behavioral Exercise Training is effective for prostate cancer?

Research has shown that exercise can greatly benefit prostate cancer patients. One study found that prostate cancer survivors who began exercising regularly increased their activity levels. Another study discovered that exercise improved erectile function in prostate cancer patients compared to those who did not exercise. Some research even suggests that regular exercise might boost the immune system and possibly slow cancer growth. Overall, these findings suggest that a structured exercise program, such as the Behavioral Exercise Training (BET) tested in this trial, could help prostate cancer patients enhance their health and quality of life. ^{1 6 7 8 9}

Who Is on the Research Team?

Alexander Lucas, PhD

Principal Investigator

Virginia Commonwealth University

Are You a Good Fit for This Trial?

Men over 40 (if non-Hispanic Black or rural) or over 60 up to age 85 with stage II/III/IV prostate cancer, currently on ADT, and who've completed local treatment like surgery or radiation. They must be able to use a computer or phone for the study, speak English, and not have serious health issues that would make exercise unsafe.

Inclusion Criteria

Willing to give informed consent and sign a HIPAA authorization form

My prostate cancer is at stage II, III, or IV.

No hearing or sight impairments that result in inability to use the telephone or hear normal conversation

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 remotely delivered behavioral exercise training intervention while receiving Androgen Deprivation Therapy

12 weeks

Remote sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Behavioral Exercise Training (BET)

Trial Overview

The trial is testing a remote Behavioral Exercise Training program designed for men undergoing hormone therapy for prostate cancer. The goal is to refine this program before it's tested in a larger group of participants.

How Is the Trial Designed?

Group I: Behavioral exercise training (BET) to introduce behavioral skills for adopting an exercise program Experimental Treatment 1 Intervention

Single-arm, ORBIT-prospective, multicenter, nonblinded clinical trial, feasibility pilot. The BET intervention will be delivered and refined over 12 weeks. The protocol aim is to enroll men from the same representative groups of underserved men in groups of 5-10, to foster social support and group cohesion.

Who Is Running the Clinical Trial?

Virginia Commonwealth University

Lead Sponsor

Trials

732

Recruited

22,900,000+

NRG Oncology

Collaborator

Trials

242

Recruited

105,000+

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]

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 study of 40 Italian men newly diagnosed with prostate cancer revealed that while 65% reported being physically active, over half did not meet recommended exercise levels, indicating a need for improved physical activity among this group.

Despite many participants being aware of their unhealthy habits, such as high alcohol consumption and being overweight, most were unwilling to change their lifestyle, highlighting the importance of healthcare professionals to encourage motivation for healthier behaviors during this critical time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical exercise habits, lifestyle behaviors, and motivation to change among men with prostate cancer: a cross-sectional study. Bressi, B., Iotti, C., Cagliari, M., et al.[2022]

A systematic review of 20 randomized controlled trials found that diet interventions, either alone or combined with exercise, can lead to significant weight loss in men treated for prostate cancer, with weight loss ranging from 0.8 kg to 6.1 kg.

Exercise alone did not result in weight loss, as most trials focused on improving fitness and quality of life rather than reducing body weight.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of dietary and exercise interventions on body weight in prostate cancer patients: a systematic review. Mohamad, H., McNeill, G., Haseen, F., et al.[2022]

The ENGAGE study, involving 147 prostate cancer survivors, demonstrated that an exercise intervention significantly increased participants' task self-efficacy, meaning they felt more confident in their ability to engage in vigorous physical activity (VPA) after the program.

Task self-efficacy was found to partially mediate the positive effects of the exercise intervention on VPA, indicating that improving confidence in exercise capability is crucial for enhancing physical activity levels in prostate cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mechanisms of Physical Activity Behavior Change for Prostate Cancer Survivors: A Cluster Randomized Controlled Trial. Craike, MJ., Gaskin, CJ., Mohebbi, M., et al.[2020]

The study demonstrated that a web-based behavioral intervention for men with prostate cancer is feasible and acceptable, with a high follow-up rate of 82.7% at 3 months and 77.2% at 6 months among 202 participants.

Participants who received the most comprehensive intervention (level 4) showed small improvements in diet and physical activity compared to those in the least intensive group (level 1), indicating that more tailored support may enhance health behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and Acceptability of a Remotely Delivered, Web-Based Behavioral Intervention for Men With Prostate Cancer: Four-Arm Randomized Controlled Pilot Trial. Chan, JM., Van Blarigan, EL., Langlais, CS., et al.[2021]

In a study of 71 men with low-risk prostate cancer, those who engaged in at least 3 hours of vigorous physical activity per week showed up-regulation of important pathways related to cell cycling and DNA repair, suggesting a potential protective effect against cancer progression.

The research indicates that vigorous activity may influence gene expression in normal prostate tissue, highlighting biological mechanisms that could help reduce the risk of prostate cancer progression, although further studies are needed to validate these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical activity and prostate gene expression in men with low-risk prostate cancer. Magbanua, MJ., Richman, EL., Sosa, EV., et al.[2021]

Exercise significantly benefits men undergoing androgen deprivation therapy (ADT) for prostate cancer by improving various health aspects such as aerobic fitness, muscular strength, quality of life, and mental wellbeing, without negatively affecting the efficacy of ADT.

The review supports that exercise can be safely integrated into routine prostate cancer care, with recommendations for moderate-to-high intensity aerobic and resistance training supervised by qualified professionals to maximize therapeutic effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise medicine for the management of androgen deprivation therapy-related side effects in prostate cancer. Cormie, P., Zopf, EM.[2021]

Exercise training (ET) combined with behavioral support is a feasible and acceptable primary therapy for men with low/intermediate-risk localized prostate cancer, with 92% of participants completing the 12-month study.

Participants in the ET group showed significant health improvements, including a reduction in body mass, lower blood pressure, and enhanced quality of life, with no serious adverse events reported.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise training as a novel primary treatment for localised prostate cancer: a multi-site randomised controlled phase II study. Bourke, L., Stevenson, R., Turner, R., et al.[2021]

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]

A 3-month supervised exercise program significantly preserved lean muscle mass and prevented fat gain in men undergoing androgen-deprivation therapy (ADT) for prostate cancer, compared to usual care.

The exercise intervention also improved various health outcomes, including cardiovascular fitness, muscular strength, sexual function, and mental health, suggesting that exercise can effectively reduce treatment-related toxicity and enhance quality of life during ADT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can supervised exercise prevent treatment toxicity in patients with prostate cancer initiating androgen-deprivation therapy: a randomised controlled trial. Cormie, P., Galvão, DA., Spry, N., et al.[2022]

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