Prostate Cancer Clinical Trial
Diet and Exercise Interventions Among Men With Prostate Cancer (Prostate 8-II)
The Prostate 8-II study is a 2-year 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.
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.
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
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 surgery, cardiac catheterization, or coronary angioplasty
Pacemaker/implantable cardiac defibrillator/rhythm disturbance
Heart valve disease
Congenital heart disease
Kidney (renal) disease
Chest discomfort with exertion
Dizziness, fainting, or blackouts
Unpleasant awareness of forceful, rapid or irregular heart rate
Burning or cramping sensations in your lower legs when walking short distance
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
Men who are already meeting all of the 7 prostate-specific dietary recommendations
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There is 1 Location for this study
San Francisco California, 94143, United States
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