Diet and Exercise Interventions Among Men With Prostate Cancer (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:

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

SECONDARY OBJECTIVES:

1. 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:

1. 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).

1. 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.