Clinical trial NCT03999151: Diet and Exercise Interventions Among Men With Prostate Cancer (Prostate 8-II)
Official title: A Randomized Controlled Trial of Diet & Exercise Interventions Among Men With Prostate Cancer - II (Prostate 8-II)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Prostate Cancer
Keywords: Exercise
Diet
Lifestyle
Digital
Text messaging
Coach
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2019-06-26
Enrollment: 204
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed description: This is a PI initiated, randomized controlled trial of four exercise and diet interventions among men opting for radical prostatectomy for prostate cancer.

The Prostate 8-II study enrolls men up to 8 weeks prior to surgery and participants remain on study for 24 cycles after surgery (1 cycle=28 days). After obtaining written informed consent, enrolled subjects will be scheduled for the baseline assessments. All participants will receive Group A educational materials and tools, but these will be distributed at different times based on group assignment. The other 3 groups will receive different combinations of exercise (Group B), diet (Group C) and exercise and diet (Group D) tools. Men in all arms will be asked to complete questionnaires at baseline, pre-surgery, and at cycles 6,12, \& 24 post-surgery, and complete blood and urine collection, diet recall, and accelerometer measurement at select time points. Specimens from biopsy and radical prostatectomy will be reviewed by the investigators' collaborator, GenomeDx, for RNA characterization and assessment of the genomic risk scores. Participants will be followed for 30 days after completion of the 2-year 24-cycle intervention period or removal from the study, or until death, whichever occurs first for any treatment-related adverse events. Following the completion of the intervention, participant's treatment and disease status will be collected on a yearly basis, for 3 more years.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. Cannot have neoadjuvant radiation or hormone therapy planned at time of enrollment (if enrolling \>4 weeks prior to RP).
2. 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:

   1. Heart attack
   2. Heart surgery, cardiac catheterization, or coronary angioplasty
   3. Pacemaker/implantable cardiac defibrillator/rhythm disturbance
   4. Heart valve disease
   5. Heart failure
   6. Heart transplantation
   7. Congenital heart disease
   8. Diabetes
   9. Kidney (renal) disease
   10. Chest discomfort with exertion
   11. Unreasonable breathlessness
   12. Dizziness, fainting, or blackouts
   13. Ankle swelling
   14. Unpleasant awareness of forceful, rapid or irregular heart rate
   15. Burning or cramping sensations in your lower legs when walking short distance
3. Men already meeting aerobic AND resistance exercise recommendations. To be eligible, must not meet at least one of the following: (1) 150 minutes per week of planned moderate aerobic exercise or 75 minutes per week of planned vigorous aerobic exercise or combination;(2) Two or more days per week of resistance exercise; (3) Eight or more resistance exercises per session
4. Men who are already meeting all of the 7 prostate-specific dietary recommendations

Primary outcomes:
measure: Proportion of patients with detectable levels of Prostate-specific antigen (PSA)
timeFrame: 6 months and 24 months post-surgery
measure: Annual PSA recurrence rate
timeFrame: Up to 5 years
Secondary outcomes:
measure: Changes in Messenger Ribonucleic Acid (mRNA) expression patterns (focusing on change between biopsy and RP)
timeFrame: From baseline to up to 8 weeks
measure: Decipher score (focusing on change between biopsy and RP)
timeFrame: From baseline to up to 8 weeks
measure: Change in sexual function as measured by the Expanded Prostate Cancer Index Composite Short Form (EPIC-26)
timeFrame: Baseline, and 6 months, 12 months, and 24 months post-surgery
measure: Change in urinary function as measured by the EPIC-26
timeFrame: Baseline, and 6 months, 12 months, and 24 months post-surgery
measure: Change in scores on the general anxiety scale of the Patient-Reported Outcomes Measurement Information System (PROMIS)
timeFrame: Baseline, and 6 months, 12 months, and 24 months post-surgery
measure: Change in scores on the Memorial Anxiety Scale for Prostate Cancer (MAX-PC)
timeFrame: Baseline, and 6 months, 12 months, and 24 months post-surgery
measure: Change in scores on the general depression scale of the Patient-Reported Outcomes Measurement Information System (PROMIS)
timeFrame: Baseline, and 6 months, 12 months, and 24 months post-surgery
measure: Change in scores on the SF-12
timeFrame: Baseline, and 6 months, 12 months, and 24 months post-surgery
measure: Change in physical activity over time
timeFrame: Baseline, and 6 months, 12 months, and 24 months post-surgery
measure: Change in scores on the Godin-Shephard Leisure-Time Physical Activity Questionnaire
timeFrame: Baseline, and 6 months, 12 months, and 24 months post-surgery
measure: Change in Harvard Food Frequency Questionnaire (FFQ) over time
timeFrame: Baseline, and 6 months, 12 months, and 24 months post-surgery
measure: Diet recall
timeFrame: Baseline, and 6 months, 12 months, and 24 months post-surgery
measure: Intervention feasibility and acceptability (intervention arms)
timeFrame: Baseline, and 6 months, 12 months, and 24 months post-surgery
measure: Self/efficacy confidence in adopting healthy behaviors over time
timeFrame: Baseline, and 6 months, 12 months, and 24 months post-surgery
measure: Changes in scores on the Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Baseline, and 6 months, 12 months, and 24 months post-surgery
measure: Changes in perceived social support
timeFrame: Baseline, and 6 months, 12 months, and 24 months post-surgery
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco (UCSF)
state: California
Study officials:
affiliation: University of California, San Francisco
name: Stacey A Kenfield, DSc
role: PRINCIPAL_INVESTIGATOR
References: