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

A Randomized Controlled Trial of Diet & Exercise Interventions Among Men With Prostate Cancer - II (Prostate 8-II)

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.

PRIMARY OBJECTIVE:

I. To examine the effects of 2-year exercise and/or diet interventions on time to prostate-specific antigen (PSA) recurrence after RP.

SECONDARY OBJECTIVES:

I. Assess the proportion of participants with PSA recurrence at 6-, 12-and 24-months post-surgery.

II. To examine quality of life (QOL) across intervention groups over time. Outcomes will include sexual and urinary function, anxiety, depression, and overall QOL assessed at all timepoints.

III. To examine intervention feasibility measured by intervention component use.

IV. To examine exercise and diet behaviors across groups over time using patient reported data and accelerometer data.

EXPLORATORY OBJECTIVES:

I. To examine mRNA expression pathways/scores in prostate tissue at RP accounting for baseline factors.

II. To examine Decipher prognostic scores in RP tissue, accounting for baseline factors.

III. To examine longitudinal changes in PSA from baseline to 12 and 24 months. IV. To examine intervention acceptability (self-report: surveys and/or interviews).

V. To examine the effect of the interventions on exercise and diet confidence (self-report from surveys and coaching calls). Additionally, investigators will also examine other behavioral constructs in a similar manner (social support, perceived barriers, use of change strategies).

VI. To examine changes in blood biomarkers across groups over time, including metabolic markers, CRP, HbA1c, and lipid panel.

VII. To examine changes in body weight, and waist and hip circumference across groups over time.

The Prostate 8-II study enrolls participants up to 8 weeks prior to surgery. Participants may continue the intervention from time of study entry to 96 weeks after RP surgery.

All participants will receive Group A educational materials and tools, but these will be distributed at different times based on group assignment.

The remaining 3 groups will receive different combinations of exercise (Group B), diet (Group C) and exercise and diet (Group D) tools. Participants 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. Following the completion of the intervention, participant's treatment and disease status will be collected on a yearly basis, for up to 3 additional years.

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