Exercise for Prostate Cancer

Recruiting at 2 trial locations

Overseen By Christina Dieli-Conwright, PhD, MPH

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Dana-Farber Cancer Institute

Disqualifiers: Metastasis, Other active malignancies, others

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

Compensation: Varies

Number of Visits: 3

Duration: 16 weeks

68 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a 16-week, home-based exercise program can slow prostate cancer progression in Black men under active surveillance. The program includes high-intensity interval training (HIIT), which involves short bursts of intense exercise followed by rest. Participants will either follow this exercise plan or continue with their usual care for comparison. Men who identify as Black, have early-stage prostate cancer, are not planning invasive treatments soon, and currently exercise less than an hour weekly might be suitable candidates. As an unphased trial, this study provides participants the chance to contribute to important research that could enhance future care strategies.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the study team or your doctor.

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

Research has shown that high-intensity interval training (HIIT) is generally safe and well-tolerated by cancer patients, including those with prostate cancer. One study found that HIIT improved fitness and quality of life while reducing pain and blood pressure, indicating safety and comfort during exercise. Another study demonstrated that HIIT boosts fitness levels and reduces tiredness in prostate cancer patients, suggesting it is manageable for them.

Importantly, there have been no significant reports of serious side effects from HIIT in these cases. While participants might feel tired after exercising, they usually do not experience harmful effects. Overall, the evidence supports HIIT as a safe exercise option for people with cancer. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the potential of high-intensity interval training (HIIT) as a complementary approach for managing prostate cancer. Unlike traditional treatments like surgery, radiation, or hormone therapy, which directly target cancer cells, HIIT focuses on improving patients' overall physical fitness and cardiovascular health. The trial aims to determine if this type of exercise can enhance quality of life, boost physical function, and potentially improve outcomes for prostate cancer patients. This innovative approach could offer a non-invasive option that empowers patients to actively participate in their own care.

What evidence suggests that this exercise program might be an effective treatment for prostate cancer?

This trial will compare a 16-week high-intensity interval training (HIIT) exercise program with usual care for men with prostate cancer. Studies have shown that HIIT can benefit men with prostate cancer. For example, a 12-week HIIT program improved key health indicators in men under close monitoring. Another study found that HIIT enhanced fitness, improved quality of life, and reduced pain and blood pressure. Research also suggests that HIIT may improve heart and lung health more effectively than moderate exercise. Additionally, exercise in prostate cancer patients may increase substances in the body that help slow tumor growth. These findings suggest HIIT could be a promising way to manage prostate cancer. ^{2 3 5 6 7}

Who Is on the Research Team?

Christina Dieli-Conwright, PhD, MPH

Principal Investigator

Dana-Farber Cancer Institute

Are You a Good Fit for This Trial?

This trial is for Black men over 18 with early-stage prostate cancer who are on active surveillance. They should be able to visit Dana-Farber Cancer Institute, understand English, sign consent forms, and have medical clearance to exercise. They must do less than 60 minutes of moderate-to-vigorous exercise weekly and not plan any invasive treatments for the next 16 weeks.

Inclusion Criteria

I am currently being closely monitored for my condition without active treatment.

I do not plan to undergo invasive prostate cancer treatment within the next 16 weeks.

I have been diagnosed with early-stage prostate cancer.

Exclusion Criteria

I have cancer that has spread or I am being treated for another cancer.

Unstable comorbidities that prevent participation in moderate-to-vigorous intensity exercise

I am currently undergoing treatment aimed at curing my prostate cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants undergo a 16-week, home-based, virtually supervised exercise program or usual care

16 weeks

Virtual training sessions three times weekly for Group A; Testing visits at Week 1, 9, and 19 for Group A; Testing visits at Week 1 and 18 for Group B

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

1 visit (in-person)

Open-label extension (optional)

Participants in Group B may opt into a 16-week HIIT exercise program after the main trial

16 weeks

What Are the Treatments Tested in This Trial?

Interventions

• High-Intensity Interval Training Exercise Program

Trial Overview The REMOVE Trial tests if a home-based, virtual high-intensity interval training (HIIT) program can slow prostate cancer progression in participants. It's a supervised 16-week aerobic exercise regimen designed specifically for this study.

How Is the Trial Designed?

Group I: Group B: 16-Week Usual Care Experimental Treatment 1 Intervention

Participants will be allocated in a 1:1 ratio, using a permuted blocked design with varying block size. Study procedures will be conducted as follows: * Testing visits at Week 1 and 18 for physical exams, physical fitness and function assessments, and survey questionnaires. * Upon completion of post-intervention assessments, participants will have the option to take part in the 16-week HIIT exercise program.

Group II: Group A: 16-Week HIIT Exercise Program Experimental Treatment 1 Intervention

Participants will be allocated in a 1:1 ratio, using a permuted blocked design with varying block size. Study procedures will be conducted as follows: * Testing visits at Week 1, 9, and 19 for physical exams, physical fitness and function assessments, survey questionnaires, and cardiopulmonary fitness assessment. * Virtual, aerobic training sessions three times weekly with trained oncology exercise specialist.

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

High-intensity interval training (HIIT) and resistance training (RT) are feasible and can improve muscle strength in men with prostate cancer on active surveillance, with HIIT increasing leg press strength and RT enhancing multiple strength measures.

RT specifically increased serum insulin-like binding protein-3 (IGFBP-3), which may help suppress tumor-promoting effects of insulin-like growth factor-I (IGF-I), suggesting a potential mechanism for its benefits in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-intensity interval training or resistance training versus usual care in men with prostate cancer on active surveillance: a 3-arm feasibility randomized controlled trial. Papadopoulos, E., Gillen, J., Moore, D., et al.[2022]

A scoping review of 69 studies on high-intensity interval training (HIIT) in older adults found that HIIT protocols are generally well-tolerated and can provide significant health benefits, particularly in improving cardiorespiratory fitness.

Most research has focused on healthy older adults, highlighting a need for larger studies and more investigation into HIIT's effects on older adults with various health conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-Intensity Interval Training in Older Adults: a Scoping Review. Marriott, CFS., Petrella, AFM., Marriott, ECS., et al.[2021]

In a study involving 52 men with prostate cancer on active surveillance, those participating in a 12-week supervised high-intensity interval training (HIIT) program showed excellent adherence, attending 96% of sessions and reporting increased enjoyment and motivation for exercise after the program.

The HIIT group not only felt more in control and confident about their exercise plans compared to the usual care group, but they also faced minimal barriers to participation, indicating that HIIT could be a highly effective and motivating exercise option for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of supervised high-intensity interval training on motivational outcomes in men with prostate cancer undergoing active surveillance: results from a randomized controlled trial. Kang, DW., Boulé, NG., Field, CJ., et al.[2022]

In a study of 30 men with localized prostate cancer, preoperative high-intensity interval training (HIIT) did not show a significant difference in tumor natural killer (NK)-cell infiltration compared to usual care, suggesting that HIIT alone may not enhance this immune response.

However, within the group that participated in HIIT, there was a significant increase in NK-cell infiltration when analyzed per protocol, indicating that more consistent exercise sessions may positively influence immune cell activity in tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise training to increase tumour natural killer-cell infiltration in men with localised prostate cancer: a randomised controlled trial. Djurhuus, SS., Simonsen, C., Toft, BG., et al.[2023]

In a study of 72 prostate cancer patients undergoing radiation therapy, both high-intensity interval training (HIIT) and resistance training (RES) significantly reduced cancer-treatment-related fatigue compared to usual care, indicating their efficacy in managing side effects of treatment.

Both exercise modalities were found to be safe, with no adverse events reported, and they improved functional exercise capacity, demonstrating that structured exercise can be beneficial during cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of high-intensity interval training compared with resistance training in prostate cancer patients undergoing radiotherapy: a randomized controlled trial. Piraux, E., Caty, G., Renard, L., et al.[2021]

Whole-body electromyostimulation (WB-EMS) has been shown to significantly inhibit the growth and increase the death of prostate and colon cancer cells, based on serum analysis from advanced cancer patients who underwent a 12-week exercise program.

The study identified exercise-sensitive genes in prostate cancer cells that may play a role in how exercise affects cancer cell growth and apoptosis, highlighting the potential of incorporating exercise into cancer treatment plans, especially for patients who are physically weakened.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical activity and advanced cancer: evidence of exercise-sensitive genes regulating prostate cancer cell proliferation and apoptosis. Schwappacher, R., Schink, K., Sologub, S., et al.[2021]

A 12-week exercise program significantly improved physical function and health quality of life in 17 prostate cancer patients undergoing androgen deprivation therapy, with benefits lasting for 3-6 months post-program.

High-intensity interval training (HIIT) was more effective than moderate-intensity continuous training (MICT) for enhancing muscle endurance, which is crucial for preventing falls and fractures in older patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Exercise on Physical Function and Quality of Life in Prostate Cancer Patients Receiving Androgen Deprivation Therapy: High-Intensity Interval Training versus Moderate-Intensity Continuous Training. Yoo, S., Lee, KH., Jamrasi, P., et al.[2023]

In a study of 40 men undergoing chemotherapy for testicular cancer, only one participant experienced a thromboembolic event during a 6-week high-intensity interval training (HIIT) program, suggesting that HIIT may not significantly increase the risk of such events in this population.

The HIIT program led to significant improvements in upper and lower body strength, indicating that it can be a feasible exercise option for men with testicular cancer undergoing chemotherapy, although no significant changes in cardiorespiratory fitness were observed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-intensity interval training and thromboembolic events during chemotherapy for testicular cancer: a retrospective analysis from the Body & Cancer cohort. Bloomquist, K., Andersen, C., Munck, S., et al.[2023]

High-intensity interval training (HIIT) significantly improves aerobic capacity and reduces fatigue in prostate cancer patients, as shown in a meta-analysis of 6 studies involving 215 male participants with an average age of 64.4 years.

HIIT also effectively decreases PSA levels in prostate cancer patients, indicating potential benefits for disease management, although it does not significantly impact inflammatory markers like IL-6 or TNF-α.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of high-intensity interval training on aerobic capacity and fatigue among patients with prostate cancer: a meta-analysis. Chang, M., Wang, J., Hashim, HA., et al.[2022]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39009705/

Effects of high-intensity interval training on cardiometabolic ... Conclusions: The ERASE Trial showed that a 12-week aerobic HIIT program improved several cardiometabolic biomarkers in patients with prostate cancer on AS that ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S1440244023004218

Clinical updates on the effects of high intensity interval ... Participation in HIIT exercise was associated with higher retention and improvements in aerobic fitness, quality of life, pain and diastolic blood pressure.

3. frontiersin.org frontiersin.org/journals/physiology/articles/10.3389/fphys.2025.1594574/full

Effects of high-intensity interval training (HIIT) versus ... Conclusion: HIIT appears superior to MICT in enhancing VO2 peak and, consequently, cardiopulmonary function in cancer survivors. Nonetheless, ...

4. nature.com nature.com/articles/s41391-023-00661-7

Can high-intensity interval training impact tumor ... Exercise in advanced prostate cancer elevates myokine levels and suppresses in-vitro cell growth. Prostate Cancer Prostatic Dis. 2022;25:86–92.

5. ijbnpa.biomedcentral.com ijbnpa.biomedcentral.com/articles/10.1186/s12966-022-01365-2

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.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10584719/

Effects of high-intensity interval training on functional ... This review investigates the effect of HIIT on functional performance in cancer patients. We reviewed the relative peak oxygen uptake (relV̇O 2PEAK ) and meta- ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9580114/

Effect of high-intensity interval training on aerobic capacity ... HIIT improves aerobic capacity, fatigue, and PSA levels among PCa patients but does not significantly affect IL-6 or TNF-α content.