Diet and Exercise for Prostate Cancer

(Prostate 8-II Trial)

Overseen By Imelda A Tenggara

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: University of California, San Francisco

Disqualifiers: Heart disease, Diabetes, Kidney disease, others

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

Compensation: Varies

Number of Visits: 2

Duration: 24 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how different combinations of diet and exercise support can improve health and quality of life for men undergoing prostate surgery. Participants receive various educational tools and coaching to help them adopt healthier habits. The trial includes groups focusing on exercise, diet, or both, to determine which approach works best. Men with non-metastatic prostate cancer who plan to have prostate surgery and have regular internet access might be a good fit.

As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance recovery and well-being after prostate surgery.

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 mainly focuses on diet and exercise changes.

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

Research has shown that exercise and dietary changes are generally safe and can benefit men with prostate cancer. Structured diet and exercise programs can lead to weight loss and better blood sugar control in overweight men with this condition. Studies have also found that regular physical activity can reduce the risk of dying from prostate cancer by 30% and improve overall health. While these lifestyle changes are usually manageable, consulting a healthcare provider before starting any new exercise or diet plan is advisable to ensure it suits individual health needs. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how personalized lifestyle changes, specifically diet and exercise, can impact prostate cancer recovery and management. Unlike standard treatments that often focus on surgery, radiation, or medication, this trial looks at integrating comprehensive lifestyle modifications through educational materials and coaching. The trial is distinctive because it provides participants with continuous support, such as online tools, text messages, and personalized coaching sessions over two years, to help them make sustainable changes in their diet and exercise routines. By studying these lifestyle interventions, researchers hope to find out if these changes can significantly improve recovery and quality of life for men with prostate cancer.

What evidence suggests that this trial's treatments could be effective for prostate cancer?

This trial will compare different approaches to diet and exercise for men with prostate cancer. Studies have shown that a structured diet and exercise program can greatly benefit these patients. Research indicates that such lifestyle changes lead to weight loss and better blood sugar control, both crucial for overall health. Exercise has improved measurable health indicators and enhanced patients' quality of life. While exercise might not shrink tumors, it can increase oxygen levels in the tumor and improve recovery chances. Overall, adopting healthy diet and exercise habits can lead to better health outcomes for men with prostate cancer. ^{2 3 6 7 8}

Who Is on the Research Team?

Stacey A Kenfield, DSc

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

This trial is for men over 18 with non-metastatic prostate cancer who've chosen surgery (radical prostatectomy) and can read English. They need internet access and text messaging. It's not for those already following exercise guidelines, planning radiation or hormone therapy before surgery, or have health issues that make exercise risky without doctor approval.

Inclusion Criteria

I have prostate cancer and am choosing surgery as my primary treatment.

Able to speak and read English

You need to have a device that can connect to the internet and send text messages.

Exclusion Criteria

I am not scheduled for radiation or hormone therapy before surgery if enrolling more than 4 weeks before my surgery.

I follow all 7 prostate-specific dietary guidelines.

I have a heart condition or other listed health issues that prevent me from doing intense exercise.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Up to 8 weeks

1 visit (in-person)

Baseline Assessment

Baseline assessments including questionnaires, blood and urine collection, diet recall, and accelerometer measurement

1 week

1 visit (in-person)

Treatment

Participants receive educational materials and tools related to diet and exercise, with interventions varying by group assignment

24 months

Quarterly phone sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment, with annual collection of treatment and disease status

3 years

Annual follow-up

What Are the Treatments Tested in This Trial?

Interventions

• Exercise and Diet

Trial Overview

The Prostate 8-II study tests different diet and exercise educational tools on biological outcomes, clinical recovery, and life quality in men undergoing prostate cancer surgery. Participants are randomly assigned to various combinations of these interventions.

How Is the Trial Designed?

Group I: Arm D (Arm A + Exercise + Diet) Experimental Treatment 1 Intervention

Arm D receives the following: Arm A material plus access to an online portal with additional educational materials to help improve exercise and diet habits and various tools, such as the ability to track exercise and diet; additional educational print materials on exercise and diet; additional text messages over 2 years that supports healthy exercise and diet habits; a 1-hour phone session at the start of the study followed by eight 30-minute quarterly phone sessions with an exercise coach over 2 years; and a 1-hour phone session at the start of the study followed by eight 30-minute quarterly phone sessions with a diet coach over 2 years.

Group II: Arm C (Arm A + Diet) Experimental Treatment 1 Intervention

Arm C receives the following: Arm A material plus access to an online portal with additional educational materials to help improve diet habits and various tools, such as the ability to track diet; additional educational print materials on diet; additional text messages over 2 years that supports healthy diet habits; and a 1-hour phone session at the start of the study followed by eight 30-minute quarterly phone sessions with a diet coach over 2 years.

Group III: Arm B (Arm A + Exercise) Experimental Treatment 1 Intervention

Arm B receives the following: Arm A material plus access to an online portal with additional educational materials to help improve exercise habits and various tools, such as the ability to track exercise; additional educational print materials on exercise; additional text messages over 2 years that supports healthy exercise habits; and a 1-hour phone session at the start of the study followed by eight 30-minute quarterly phone sessions with an exercise coach over 2 years.

Group IV: Arm A: Reference Group Active Control 1 Intervention

Arm A will receive print educational materials about the benefits of exercise and diet for men with prostate cancer, with recommendations geared at men living with prostate cancer, mailed around the date of surgery. They also receive a 10-week text messaging program focused on recovery after radical prostatectomy surgery.

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+

Published Research Related to This Trial

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]

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 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]

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]

Only a small percentage of long-term prostate cancer survivors (11.8% using diet and 7.8% using exercise) actively employed dietary changes or exercise to manage their condition, indicating a potential gap in awareness or utilization of these strategies.

Younger, more educated survivors, and those involved in support groups were more likely to adopt these lifestyle changes, suggesting that targeted counseling could enhance the use of diet and exercise to improve quality of life and cancer outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Factors associated with the use of diet and the use of exercise for prostate cancer by long-term survivors. Hughes, S., Egger, S., Carle, C., et al.[2020]

The Prostate 8-II trial is a 4-arm randomized controlled trial involving 200 men with prostate cancer, aiming to assess the effects of exercise and diet interventions on cancer recurrence and patient quality of life over a 24-month period after radical prostatectomy.

Participants are assigned to one of four groups (exercise-only, diet-only, exercise + diet, or usual care) and will receive various resources and support to help achieve their health goals, with the primary focus on measuring biochemical recurrence and secondary outcomes related to tumor biomarkers and quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Protocol for a 4-arm randomized controlled trial testing remotely delivered exercise-only, diet-only, and exercise + diet interventions among men with prostate cancer treated with radical prostatectomy (Prostate 8-II). Van Blarigan, EL., Chan, JM., Sanchez, A., et al.[2023]

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