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).

Nutrition and physical activity are associated with prostate cancer recurrence and mortality. Few randomized controlled trials (RCT) have examined the effects of long-term exercise and diet changes on prostate cancer clinical, biological, and patient-reported outcomes.

Prostate 8-II is a 4-arm RCT among 200 men with prostate cancer who chose radical prostatectomy (RP) as their primary treatment. Men are enrolled prior to RP and randomized to exercise-only, diet-only, exercise + diet, or usual care (50/arm). Participants begin their assigned intervention 0-5 weeks prior to RP and continue for 24-months following surgery. The 3 active intervention arms receive access to a web-portal and text messages, coaching calls, and other intervention resources (e.g., heart rate sensor and resistance bands and/or recipe booklet). Weekly exercise goals for the exercise intervention groups are 150 min moderate or 75 min vigorous aerobic exercise, 2 strength sessions, and 2 flexibility sessions. Diet intervention groups work with a dietitian to customize their goals (e.g., increase cruciferous vegetables, cooked tomatoes, healthy fats, fish; limit processed meats, whole milk). The primary endpoint is biochemical recurrence. Secondary endpoints include change in tumor biomarkers from biopsy to RP as well as patient-reported outcomes (e.g., quality-of-life), blood and urine biomarkers, and anthropometry at 0, 6, 12, and 24 months.

This 4-arm RCT will examine the impact of change in exercise and diet (alone or in combination) on prostate cancer recurrence, biology, and quality-of-life.

Contemporary clinical trials. 2023 Jan 05 [Epub ahead of print]

Erin L Van Blarigan, June M Chan, Ada Sanchez, Li Zhang, Kerri Winters-Stone, Vivian Liu, Greta Macaire, Neil Panchal, Rebecca E Graff, Imelda Tenggara, Anthony Luke, Jeffry P Simko, Matthew R Cooperberg, Peter R Carroll, Stacey A Kenfield

Department of Urology, University of California, San Francisco, (UCSF), San Francisco, CA, United States of America; Department of Epidemiology and Biostatistics, University of California, San Francisco, San Francisco, CA, United States of America; UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, CA, United States of America., Department of Urology, University of California, San Francisco, (UCSF), San Francisco, CA, United States of America., Department of Epidemiology and Biostatistics, University of California, San Francisco, San Francisco, CA, United States of America; UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, CA, United States of America; Department of Medicine, University of California, San Francisco, San Francisco, CA, United States of America., Division of Oncological Sciences, School of Medicine, Oregon Health & Sciences University, Portland, OR, United States of America., Department of Epidemiology and Biostatistics, University of California, San Francisco, San Francisco, CA, United States of America., UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, CA, United States of America., UCSF Human Performance Center, San Francisco, CA, United States of America., UCSF Human Performance Center, San Francisco, CA, United States of America; Department of Orthopedic Surgery, University of California, San Francisco, San Francisco, CA, United States of America., Department of Urology, University of California, San Francisco, (UCSF), San Francisco, CA, United States of America; Department of Pathology, University of California, San Francisco, San Francisco, CA, United States of America., Department of Urology, University of California, San Francisco, (UCSF), San Francisco, CA, United States of America; UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, CA, United States of America., Department of Urology, University of California, San Francisco, (UCSF), San Francisco, CA, United States of America; Department of Epidemiology and Biostatistics, University of California, San Francisco, San Francisco, CA, United States of America; UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, CA, United States of America. Electronic address: .