Exercise for Enlarged Prostate

(PROUD Trial)

Recruiting at 1 trial location

Overseen By Stacey Kenfield, ScD

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: University of California, San Francisco

Must be taking: BPH medications

Must not be taking: Overactive bladder medications

Disqualifiers: Cancer, Neurologic conditions, Heart disease, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12 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 12-week exercise program can assist men experiencing urination difficulties due to an enlarged prostate, known as benign prostatic hyperplasia (BPH). Participants will either follow a personalized exercise plan or receive health education to assess which approach improves symptoms. The trial targets men aged 60 or older who have moderate-to-severe urination issues and have been mostly inactive. The study seeks to provide insights into whether exercise can effectively treat BPH symptoms. As an unphased trial, it offers participants the chance to contribute to valuable research that could lead to new non-invasive treatment options for BPH.

Will I have to stop taking my current medications?

The trial requires that participants do not start, stop, or change their BPH medications or other medications affecting urinary symptoms for the entire study period of 7 months, unless necessary by their clinician.

What prior data suggests that this exercise intervention is safe for older men with LUTS/BPH?

Research has shown that exercise can safely help manage symptoms of an enlarged prostate. Studies have found that regular physical activity may reduce the risk of developing benign prostatic hyperplasia (BPH), or an enlarged prostate, by half compared to inactivity. This indicates that exercise is generally safe and could ease symptoms without major risks.

One study found that spending less time sitting also seemed to protect against BPH, further supporting the idea that staying active is beneficial. While exercise doesn't prevent BPH from developing, it does help reduce the symptoms. Overall, evidence suggests that exercise is a safe and helpful way to support prostate health. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for an enlarged prostate, which often include medications like alpha-blockers and 5-alpha-reductase inhibitors, as well as surgical options, the use of exercise offers a non-invasive alternative with potentially fewer side effects. Researchers are particularly excited about this approach because it not only aims to alleviate symptoms but also promotes overall health and wellness. The unique aspect of using exercise is that it could improve prostate health while enhancing cardiovascular fitness and mental well-being, offering a holistic benefit that standard medication or surgery might not provide.

What evidence suggests that exercise might be an effective treatment for an enlarged prostate?

Research has shown that physical activity can help reduce symptoms of an enlarged prostate. In this trial, participants in the Exercise Arm will undergo a personalized 12-week exercise program. Studies have found that men who exercise frequently experience fewer urinary problems related to benign prostatic hyperplasia (BPH). Engaging in moderate to vigorous exercise may lower the risk of these symptoms by up to 25% compared to inactivity. Additionally, running longer distances each week might decrease the chance of developing BPH, regardless of weight or diet. Regular physical activity is associated with a significantly lower risk of BPH. ^{2 6 7 8 9}

Who Is on the Research Team?

Scott R. Bauer, MD, ScM

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

Men aged 60+ with moderate-to-severe urinary symptoms due to enlarged prostate, not very active physically, can walk 400m unaided (cane ok), and have a smartphone. They shouldn't be on certain bladder medications or have had recent changes in prostate meds, nor should they have a history of specific urologic surgeries or cancers.

Inclusion Criteria

I am 60 years old or older.

I was assigned male at birth.

I have had moderate to severe urinary symptoms in the past month.

Exclusion Criteria

I have had narrowings in my urethra before.

Post-void residual >=450ml measured by ultrasound during screening or the baseline visit

Use of a permanent or temporary urinary catheter

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a 12-week remote exercise intervention or health education control

12 weeks

Weekly remote monitoring and bi-weekly phone calls

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Exercise

Trial Overview The study is testing if a remote exercise program helps older men with urinary issues from an enlarged prostate better than just receiving health education. Participants will either do the exercises or get calls and newsletters for comparison.

How Is the Trial Designed?

Group I: Exercise Arm Experimental Treatment 1 Intervention

Participants in this study arm will receive an individualized 12-week exercise intervention plus a remote health education program.

Group II: Control Arm Active Control 1 Intervention

Participants in this study arm will receive a remote health education program which consists of twice-monthly "Successful Aging" newsletters and phone calls to reinforce and discuss topics in each newsletter.

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

University of California, Berkeley

Collaborator

Trials

193

Recruited

716,000+

University of California, San Diego

Collaborator

Trials

1,215

Recruited

1,593,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Published Research Related to This Trial

A systematic review of 21 trials involving 1748 prostate cancer patients found that resistance exercise significantly improved body composition, functional capacity, and muscle strength, with a notable reduction in fat mass and an increase in lean mass.

The study suggests that lower volume resistance training at moderate to high intensity is just as effective as higher volume training, which may help make exercise more accessible and encourage adherence among patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Resistance Exercise Dosage in Men with Prostate Cancer: Systematic Review, Meta-analysis, and Meta-regression. Lopez, P., Taaffe, DR., Newton, RU., et al.[2023]

A review of 14 studies indicates a strong inverse relationship between exercise and the development of benign prostatic hyperplasia (BPH) and lower urinary tract symptoms (LUTS), suggesting that a healthy lifestyle can significantly impact prostate health.

Proposed mechanisms for this relationship include reduced sympathetic nervous system activity, prevention of metabolic syndrome, and decreased oxidative damage to the prostate, highlighting the importance of exercise in maintaining prostate health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review of exercise and the risk of benign prostatic hyperplasia. Sea, J., Poon, KS., McVary, KT.[2010]

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]

A 10-week structured exercise program for 41 men with prostate cancer received overwhelmingly positive feedback, highlighting benefits such as increased exercise confidence, motivation, and social support.

While most participants preferred structured exercise classes, individual preferences varied, indicating that future interventions should be tailored to accommodate these differences and include ongoing patient feedback.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real World Evidence: A Quantitative and Qualitative Glance at Participant Feedback from a Free-Response Survey Investigating Experiences of a Structured Exercise Intervention for Men with Prostate Cancer. Fox, L., Cahill, F., Burgess, C., et al.[2022]

A systematic analysis of 150 YouTube videos on pelvic floor muscle training after prostate cancer surgery revealed that the overall quality of these videos is high, with average scores of 3.35 on the DISCERN Scale and 3.38 on the Global Quality Score.

The videos had a significant reach, averaging over 124,000 views, indicating that they are widely accessed by patients seeking information on postoperative exercises, highlighting the need for health professionals to ensure the accuracy and reliability of online health resources.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quality Analysis of YouTube Videos Presenting Pelvic Floor Exercises after Prostatectomy Surgery. Rodriguez-Rodriguez, AM., Blanco-Diaz, M., Lopez-Diaz, P., et al.[2021]

Pelvic floor muscle exercises significantly improved urinary symptoms, such as reduced frequency of urination and terminal dribbling, in patients after transurethral prostatectomy, with notable differences observed as early as 4 weeks post-exercise.

Patients who engaged in pelvic floor muscle exercises reported higher satisfaction with life compared to those who did not, indicating that these exercises not only help with physical symptoms but also enhance psychological and social well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The early effect of pelvic floor muscle exercise after transurethral prostatectomy. Chang, PL., Tsai, LH., Huang, ST., et al.[2006]

Men who underwent pelvic muscle exercise (PME) with biofeedback after radical prostatectomy regained urinary continence faster (mean of 51 days) compared to those who did not receive PME instruction (56 days).

While the PME/biofeedback group showed improvements in urinary incontinence metrics such as episodes and pad usage, these changes were not statistically significant, indicating that further research is needed to confirm the effectiveness of PME as a treatment for urinary incontinence post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pelvic muscle exercise/biofeedback for urinary incontinence after prostatectomy: an education program. Mathewson-Chapman, M.[2015]

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]

A systematic review of 25 randomized controlled trials found that physical exercise can significantly improve quality of life, fitness, and reduce fatigue in prostate cancer patients during and after medical treatment.

Supervised exercise programs were shown to be more effective than non-supervised ones, highlighting the importance of structured support in exercise interventions for these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical exercise interventions in prostate cancer patients--a systematic review of randomized controlled trials. Baumann, FT., Zopf, EM., Bloch, W.[2022]

Men aged 45 and over with sedentary or light occupational work had a higher risk of incidental prostate cancer, with an odds ratio of 1.9, indicating a significant association between low physical activity at work and prostate cancer risk.

Conversely, higher levels of occupational physical activity were linked to a reduced risk of prostate cancer, with odds ratios decreasing from 1.0 for sedentary jobs to 0.2 for high/very high activity levels, suggesting that being more active at work may help lower the risk of developing prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lifetime occupational physical activity and incidental prostate cancer (Canada). Bairati, I., Larouche, R., Meyer, F., et al.[2019]

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]

Engaging in a supervised exercise program before prostate surgery (prehabilitation) significantly improved muscle strength and physical function in men with prostate cancer, helping to mitigate declines after surgery.

While post-surgery rehabilitation also improved strength and function, there were no significant differences in urinary incontinence, hospital stay, or patient-reported outcomes between prehabilitation and rehabilitation groups, suggesting that pre-surgery exercise is particularly beneficial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prehabilitative versus rehabilitative exercise in prostate cancer patients undergoing prostatectomy. Singh, F., Newton, RU., Taaffe, DR., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4342314/

Physical Activity and Benign Prostatic Hyperplasia-Related ... Mechanistically, these findings suggest that PA does not prevent the initiation of BPH-related outcomes and LUTS but does lead to reduced symptom experiences ...

2. jamanetwork.com jamanetwork.com/journals/jamainternalmedicine/fullarticle/210484

Physical Activity and Benign Prostatic Hyperplasia Our results indicate that more physically active men have a lower frequency of lower urinary tract symptoms.

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0302283808001917

Physical Activity, Benign Prostatic Hyperplasia, and Lower ... Our results suggest that moderate to vigorous physical activity may reduce the risk of BPH or LUTS by as much as 25% relative to a sedentary lifestyle.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2828466/

Effects of Running Distance and Performance on Incident ... Greater distances run per week may reduce BPH risk independent of BMI, 10-km performance, and diet.

5. journals.sagepub.com journals.sagepub.com/doi/10.1177/15579883241311209

Strenuous Sports as a Preventive Tactic Against Benign ... For example, a meta-analysis showed that men who regularly participate in physical activity have a significantly reduced risk of BPH, especially ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4180167/

The Study About Physical Activity for Subjects With ... Our study showed that reducing sedentary time could have a protective effect and reduce the prevalence of BPH.

7. mdpi.com mdpi.com/1648-9144/61/8/1362

Modulating Benign Prostatic Hyperplasia Through Physical ... High levels of physical activity were associated with a cross-sectional odds ratio of 0.5 for BPH compared to inactivity, indicating a halving of the odds of ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S2287888222000381

Lifestyle habits to prevent the development of benign ... This result coincides with a meta-analysis which demonstrates that lifestyle with moderate to high intensity exercise significantly reduces the risk of BPH ...

9. health.harvard.edu health.harvard.edu/blog/exercise-and-benign-prostatic-hyperplasia-bph-201104261561

Exercise and benign prostatic hyperplasia (BPH) Emerging scientific evidence suggests that engaging in a few hours of exercise a week may help keep prostate enlargement in check. Note: Talk ...