Summary

Eligibility
for males ages 18 years and up (full criteria)
Location
at UCSF
Dates
study started
estimated completion
Principal Investigator
Stacey Kenfield, DSc (ucsf)

Description

Summary

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.

Official Title

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

Details

This is a PI initiated, randomized controlled trial of four exercise and diet interventions among 200 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. Patients 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, we will follow the patient's treatment and disease status on a yearly basis, for 3 more years.

Keywords

Prostate Cancer Exercise Diet Lifestyle Digital Text messaging Coach Prostatic Neoplasms Exercise and Diet

Eligibility

You can join if…

Open to males ages 18 years and up

  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
  6. Cleared by their physician to participate in unsupervised physical activity, if patient has certain health conditions or symptoms, outlined in

You CAN'T join if...

Exclusion Criteria:

  1. Cannot have adjuvant radiation or hormone therapy planned prior to surgery 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:
  3. Heart attack
  4. Heart surgery, cardiac catheterization, or coronary angioplasty
  5. Pacemaker/implantable cardiac defibrillator/rhythm disturbance
  6. Heart valve disease
  7. Heart failure
  8. Heart transplantation
  9. Congenital heart disease
  10. Diabetes
  11. Kidney (renal) disease
  12. . Chest discomfort with exertion
  13. . Unreasonable breathlessness
  14. . Dizziness, fainting, or blackouts
  15. . Ankle swelling
  16. . Unpleasant awareness of forceful, rapid or irregular heart rate
  17. . Burning or cramping sensations in your lower legs when walking short distance
  18. 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
  19. Men who are already meeting all of the 7 prostate-specific dietary recommendations

Location

  • University of California, San Francisco (UCSF) accepting new patients
    San Francisco California 94143 United States

Lead Scientist at UC Cancer

  • Stacey Kenfield, DSc (ucsf)
    Associate Professor, Urology. Authored (or co-authored) 76 research publications.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT03999151
Study Type
Interventional
Last Updated