Exercise Program for Prostate Cancer

(ASX Trial)

No longer recruiting at 1 trial location

Overseen By June Chan

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: University of California, San Francisco

Must not be taking: Finasteride, Dutasteride

Disqualifiers: Uncontrolled illness, Heart failure, Cancer, 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: 20

Duration: 16 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a 16-week structured exercise program might affect prostate cancer progression. Researchers aim to determine if exercise can alter genetic markers that predict aggressive cancer. Participants will either follow a specific exercise routine or receive general advice on staying active. Men with localized prostate cancer, who are on active surveillance and have a low to moderate fitness level, might be a good fit. A group of healthy men without cancer will also be included for comparison.

As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research on exercise and cancer progression.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot use finasteride or dutasteride within 3 weeks or 6 months, respectively, before joining the study.

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

Research shows that exercise is generally safe for people with prostate cancer. Studies indicate that regular physical activity can improve quality of life and reduce fatigue in cancer patients. Men who exercise often may also have a lower risk of dying from prostate cancer.

Strong evidence suggests that exercise can help lessen cancer severity and slow tumor growth. These findings indicate that joining an exercise program, like the one in this trial, is unlikely to cause harm and might actually be beneficial. Overall, exercise appears to be a safe choice for those considering this trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the exercise program for prostate cancer because it takes a unique approach compared to traditional treatments like surgery, radiation, or hormone therapy. Instead of using medications or invasive procedures, this program focuses on improving patients' overall health and well-being through regular aerobic exercise. The program is designed to enhance cardiorespiratory fitness, potentially improving quality of life and physical functioning, which are not typically addressed by conventional treatments. By targeting lifestyle changes and physical fitness, this approach may offer a complementary benefit that traditional treatments don't provide, sparking interest in its potential to support long-term health in prostate cancer patients.

What evidence suggests that this exercise program could be effective for prostate cancer?

Research has shown that exercise might help slow down prostate cancer. In this trial, participants in Arm A will engage in aerobic exercise sessions. Previous studies have found that such exercises can reduce cancer severity and prevent its spread. Another study discovered that combining aerobic exercises (like walking or cycling) with strength exercises (like lifting weights) can improve the quality of life for prostate cancer patients. Exercise also correlates with better activity levels in survivors. Thus, regular exercise could be a helpful way to manage prostate cancer and improve overall health. ^{1 3 6 7 8}

Who Is on the Research Team?

June Chan, Sc.D.

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

Men with localized prostate cancer who've chosen active surveillance and have a Gleason score ≤6 or limited Gleason 3+4, a PSA ≤15 ng/ml (or PSAD <0.15), low to moderate fitness levels, and can pass an exercise test are eligible. Exclusions include recent serious cardiovascular events, uncontrolled illnesses, prior prostate cancer treatments, certain medication use within specified time frames before the study start, and mental impairments.

Inclusion Criteria

I am a man with prostate issues, my PSA is between 10-15, and I have low-risk prostate cancer.

English-speaking

I chose to monitor my low-risk prostate cancer instead of immediate treatment.

Exclusion Criteria

I have an active heart infection.

I haven't taken finasteride in the last 3 weeks or dutasteride in the last 6 months.

I don't have any recent health issues that could worsen with exercise.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo structured aerobic training or receive usual care for 16 weeks

16 weeks

4 sessions per week (home-based)

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months

Assessments at 16 weeks, 12 months, and 24 months

What Are the Treatments Tested in This Trial?

Interventions

• Exercise

Trial Overview This trial examines if a structured aerobic training program over 16 weeks can change genomic risk scores in men with prostate cancer under active surveillance compared to usual care advice. The goal is to see if exercise affects the likelihood of disease progression.

How Is the Trial Designed?

Group I: Arm A: Exercise Experimental Treatment 2 Interventions

Arm A will engage in up to 4 aerobic sessions per week at 55% to 75% of the individually determined exercise capacity (VO2peak; determined from the cardiopulmonary exercise test (CPET) performed at baseline) for 16 weeks. This exercise prescription will be achieved through \~ 4 sessions / week. Men are provided with a heart rate monitor to help ensure they exercise in their target zone. At baseline \& week 16, all patients will complete: (1) lifestyle and quality-of-life questionnaires, (2) measurement of weight (3) collection of research fasting blood sample, (4) collection of urine sample, and (5) cardiorespiratory fitness testing. Archival biopsy tissue samples from before and after the intervention will also be requested.

Group II: Arm C: Exploratory Active Control 2 Interventions

Arm C is a non-randomized control group of men without cancer, which will receive all baseline and 16 week follow-up assessments (except tissue procurement) will engage in up to 4 aerobic sessions per week at 55% to 75% of the individually determined exercise capacity (VO2peak; determined from the cardiopulmonary exercise test performed at baseline) for 16 weeks. This exercise prescription will be achieved through \~ 4 sessions / week. Men are provided with a heart rate monitor to help ensure they exercise in their target zone. At baseline \& week 16, all patients will complete: (1) lifestyle and quality-of-life questionnaires, (2) measurement of weight (3) collection of research fasting blood sample, (4) collection of urine sample, and (5) cardiorespiratory fitness testing.

Group III: Observational Non-Randomized Group Active Control 1 Intervention

There is also a non-randomized observational component to the study where biospecimens and survey data will be collected and one CPET will be administered. Individuals who will be enrolled to this group include those who do not meet all eligibility criteria for the RCT, or those who do not wish to be in a RCT, but are interested to participate in some lifestyle research.

Group IV: Arm B: Usual Care Active Control 1 Intervention

Arm B will receive print material with physical activity guidance which includes general physical activity information (e.g., "Moving through Cancer - A Guide to Exercise for Cancer Survivors") at baseline, but no specific exercise program or goals. At the conclusion of the 16 weeks, subjects in this group will be provided with a heart rate monitor, an individualized aerobic exercise program based on their cardiorespiratory fitness test results, and opportunity to consult with study exercise physiologist (one-time).

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10854832/

The Impact of Physical Activity on the Outcomes ... Specifically, increased levels of exercise have not only been linked to an improved quality of life for PCa patients, but also to a decreased ...

2. 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.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11674139/

The Effect of Resistance and/or Aerobic Training on Quality of ... The results show that combining strength and aerobic exercise significantly improves quality of life, especially in general health, mental clarity, and sexual ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0738399125006792

Effectiveness in physical activity levels of Proactive ... The results of this study indicated a significant improvement in physical activity levels of prostate cancer survivors after implementing ...

5. nature.com nature.com/articles/s41391-021-00406-4

Exercise medicine in men with prostate cancer Exercise intervention studies in men with prostate cancer have shown well documented improvements in objective and self-reported outcomes [1] ...

6. mskcc.org mskcc.org/news/can-exercise-impact-prostate-cancer-first-of-its-kind-clinical-trial

Can Exercise Impact Prostate Cancer? A First of its Kind ... We have also found that men reporting regular exercise have a lower risk of dying from prostate cancer than those who report they did not ...

7. jamanetwork.com jamanetwork.com/journals/jamaoncology/article-abstract/2821208

Exercise for Prostate Cancer—Worthy Goals but ... The panel concluded that exercise interventions during cancer treatment reduced fatigue, enhanced quality of life, and improved physical function.

8. fredhutch.org fredhutch.org/en/diseases/prostate-cancer/treatment/diet-and-exercise.html

Impact of Diet and Exercise Studies have found that people who get regular physical activity have a slightly lower risk of prostate cancer. Vigorous activity may have a ...