Clinical trial · Interventional
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)
NCT03999151CI-TRIAL-00118222active not recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Exercise and Diet | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- ACTIVE_COMPARATOR
- label
- Arm A: Reference Group
- description
- Arm A will receive print educational materials about the benefits of exercise and diet for men with prostate cancer, with recommendations geared at men living with prostate cancer, mailed around the date of surgery. They also receive a 10-week text messaging program focused on recovery after radical prostatectomy surgery.
- interventionNames
- Behavioral: Exercise and Diet
- type
- EXPERIMENTAL
- label
- Arm B (Arm A + Exercise)
- description
- Arm B receives the following: Arm A material plus access to an online portal with additional educational materials to help improve exercise habits and various tools, such as the ability to track exercise; additional educational print materials on exercise; additional text messages over 2 years that supports healthy exercise habits; and a 1-hour phone session at the start of the study followed by eight 30-minute quarterly phone sessions with an exercise coach over 2 years.
- interventionNames
- Behavioral: Exercise and Diet
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.