NCT03999151Active, not recruiting
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)
Source: ClinicalTrials.gov · Last updated 16 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 204 (actual)
- First submitted
- 21 Jun 2019
- Start date
- 11 May 2018
- Primary completion date
- 31 Aug 2028
- Lead sponsor
- University of California, San Francisco
- Diseases
- Prostate cancer
- NCT number
- NCT03999151
What you commit to
- Study type: Interventional
- Participants enrolled: 204
- From 11 May 2018 to the primary completion date, 31 Aug 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Cannot have neoadjuvant radiation or hormone therapy planned at time of enrollment (if enrolling \>4 weeks prior to RP).
Lab values
- 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 attack
- Heart surgery, cardiac catheterization, or coronary angioplasty
- Pacemaker/implantable cardiac defibrillator/rhythm disturbance
- Heart valve disease
- Heart failure
- Heart transplantation
- Congenital heart disease
- Diabetes
- Kidney (renal) disease
- Chest discomfort with exertion
- Unreasonable breathlessness
- Dizziness, fainting, or blackouts
- Ankle swelling
- Unpleasant awareness of forceful, rapid or irregular heart rate
- Burning or cramping sensations in your lower legs when walking short distance
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of California, San Francisco (UCSF) Coordinator of this site? Confirm its status | San Francisco | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.