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

204 Participants Needed

Trial Summary

What is the purpose of this trial?

The Prostate 8-II study is a randomized controlled trial of testing different combinations of educational and supportive tools related to diet and exercise to evaluate biological, clinical, and quality of life outcomes in men choosing radical prostatectomy as treatment for prostate cancer.

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.

What data supports the effectiveness of the treatment Exercise and Diet for prostate cancer?

Research suggests that diet and exercise can improve quality of life and may help with weight loss in men treated for prostate cancer. Some studies indicate that these lifestyle changes are linked to better outcomes, such as reduced cancer recurrence and improved survival. ^{1 2 3 4 5}

Is the diet and exercise treatment for prostate cancer safe for humans?

Research shows that diet and exercise interventions for prostate cancer patients are generally safe, with studies reporting no serious adverse events during exercise programs. These interventions have been well-received by participants and can be safely integrated into standard cancer care. ^{2 3 4 6 7}

How does the Diet and Exercise treatment for prostate cancer differ from other treatments?

The Diet and Exercise treatment for prostate cancer is unique because it focuses on lifestyle changes to improve outcomes, such as maintaining a healthy weight and enhancing quality of life, rather than relying on medication or surgery. This approach may help reduce cancer recurrence and improve survival by promoting overall health through diet and physical activity. ^{1 2 3 8 9}

Research Team

Stacey A Kenfield, DSc

Principal Investigator

University of California, San Francisco

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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 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]

References

1. Canada 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. [2021]

2. United States 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). [2023]

3. United States pubmed.ncbi.nlm.nih.gov

The effect of dietary and exercise interventions on body weight in prostate cancer patients: a systematic review. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Prostate cancer - evidence of exercise and nutrition trial (PrEvENT): study protocol for a randomised controlled feasibility trial. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Factors associated with the use of diet and the use of exercise for prostate cancer by long-term survivors. [2020]

6. England 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). [2021]

7. Germany pubmed.ncbi.nlm.nih.gov

Effects of a lifestyle intervention on body composition in prostate cancer patients on androgen deprivation therapy. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Exercise does not counteract the effects of a "westernized" diet on prostate cancer xenografts. [2017]

9. Switzerland pubmed.ncbi.nlm.nih.gov

The Effect of Nutrition Therapy and Exercise on Cancer-Related Fatigue and Quality of Life in Men with Prostate Cancer: A Systematic Review. [2022]