Diet and Exercise Interventions Among Men With Prostate Cancer (Prostate 8-II)

NCT03999151 | Active Not Recruiting

• 3 other identifiers: 175513-HDFCCCNCI-2018-023475R01CA207749-05
• Study Type: interventional
• Target: 204
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prostate Cancer

Keywords

Exercise; Diet; Lifestyle; Digital; Text messaging; Coach

Outcome Measures

Primary Outcomes (2)

• Proportion of patients with detectable levels of Prostate-specific antigen (PSA)

  Detectable PSA will be defined based on current practice at the time of analysis. Point estimate and 95% confidence interval of the proportion of detectable PSA at 6 months and 2 years post-surgery for each group will be reported. In addition, Pearson's Chi-square test will be used to test if there are differences in the proportion of detectable PSA at least 6 weeks post-surgery among the groups. If there is a significant difference observed, a 2-sample proportion test to compare Groups B, C, and D, separately, with Group A and one another for each post-intervention time point will be performed. Point estimates and 95% confidence intervals of the recurrence proportion will be obtained for each group

  6 months and 24 months post-surgery

• Annual PSA recurrence rate

  Risk of cancer recurrence (based on current practice) measured using standard criteria using a log- rank test to evaluate the time to recurrence among groups, and multivariate Cox proportional hazards regression to obtain a hazard ratio for the time to recurrence

  Up to 5 years

Secondary Outcomes (16)

• Changes in Messenger Ribonucleic Acid (mRNA) expression patterns (focusing on change between biopsy and RP)

  From baseline to up to 8 weeks

• Decipher score (focusing on change between biopsy and RP)

  From baseline to up to 8 weeks

• Change in sexual function as measured by the Expanded Prostate Cancer Index Composite Short Form (EPIC-26)

  Baseline, and 6 months, 12 months, and 24 months post-surgery

• Change in urinary function as measured by the EPIC-26

  Baseline, and 6 months, 12 months, and 24 months post-surgery

• Change in scores on the general anxiety scale of the Patient-Reported Outcomes Measurement Information System (PROMIS)

  Baseline, and 6 months, 12 months, and 24 months post-surgery

Study Arms (4)

Arm A: Reference Group

ACTIVE COMPARATOR

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.

Behavioral: Exercise and Diet

Arm B (Arm A + Exercise)

EXPERIMENTAL

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.

Behavioral: Exercise and Diet

Arm C (Arm A + Diet)

EXPERIMENTAL

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.

Behavioral: Exercise and Diet

Arm D (Arm A + Exercise + Diet)

EXPERIMENTAL

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.

Behavioral: Exercise and Diet

Interventions

Exercise and Diet BEHAVIORAL

Behavioral program provides access to educational materials + clinical texting program (Arm A) + participant portal, text messaging, and coaching (Arms B-D)

Arm A: Reference Group; Arm B (Arm A + Exercise); Arm C (Arm A + Diet); Arm D (Arm A + Exercise + Diet)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>=18 years
• Diagnosed with non-metastatic prostate cancer and choose radical prostatectomy (RP) as primary treatment.
• Able to speak and read English
• Regular access to the Internet (via a computer, tablet, or phone) and text messaging capabilities on the phone
• Ability to understand a written informed consent document, and the willingness to sign it

You may not qualify if:

• Cannot have neoadjuvant radiation or hormone therapy planned at time of enrollment (if enrolling \>4 weeks prior to RP).
• Men who have contraindications to exercise based the American College of Sports Medicine 2016 Exercise pre-participation screening criteria (https://www.ncbi.nlm.nih.gov/pubmed/26473759), and who do not receive a physician clearance to participate in the moderate to vigorous intensity physical activity with one or more of the following self-reported conditions:
• Heart attack
• Heart surgery, cardiac catheterization, or coronary angioplasty
• Pacemaker/implantable cardiac defibrillator/rhythm disturbance
• Heart valve disease
• Heart failure
• Heart transplantation
• Congenital heart disease
• Diabetes
• Kidney (renal) disease
• Chest discomfort with exertion
• Unreasonable breathlessness
• Dizziness, fainting, or blackouts
• Ankle swelling

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of California, San Francisco (UCSF)

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Motor Activity

Interventions

Exercise; Diet

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Stacey A Kenfield, DSc

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2019
• First Posted: June 26, 2019
• Study Start: May 11, 2018
• Primary Completion (Estimated): August 31, 2028
• Study Completion (Estimated): August 31, 2028
• Last Updated: May 29, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)