Health Interventions in Men Undergoing Radical Prostatectomy- A Randomized Controlled Clinical Trial

This project will assess whether a health-promotion intervention initiated prior to and continuing beyond radical prostatectomy for the treatment of clinically localized prostate cancer results in improvements in overall health, health-related quality of life, and specific urological outcomes, specifically recovery of EF and urinary continence. While there is an abundance of literature supporting the harmful impact that obesity has on prostate cancer risk, delayed diagnosis, surgical outcomes, pathological outcomes and overall mortality, there is a paucity of data on the impact of health/fitness interventions on immediate post-operative quality of life outcomes.

Data supporting the benefit of lifestyle interventions in terms of overall health come from the Look AHEAD trial [1], which demonstrated clinically significant weight loss and improvements in diabetic control and cardiovascular risk factors in obese, type 2 diabetics. It is expected that this intervention will result in beneficial changes to the participants' overall health status as represented in the short term by improvements in objective clinical measurements (such as reduction in weight, BP, serum cholesterol and fasting serum glucose levels), and overall health-related quality of life. The investigators also hypothesize that such an intervention will result in improved post-operative urological outcomes, namely accelerated return of urinary continence and EF. Urologists are in a good position to promote healthy living, and initiating interventions such as these prior to surgery can provide the foundation of a healthy lifestyle that will enable the patient to maintain the aforementioned benefits well beyond their surgery, and extending beyond the urological domain.

The goal is to prove that patients participating in one of two lifestyle interventions, a more intense health promotion intervention or a less intense text-message program, will report improved physical parameters: BMI, BP, metabolic parameters (fasting serum glucose, serum cholesterol), health-related quality of life, recovery of EF and urinary continence (the latter three as reported by questionnaires) compared to patients who are given standard advice prior to radical prostatectomy.

Specific Aim: To evaluate by means of a randomized, controlled, clinical trial the relative benefits and costs of an intensive health-promotion intervention, compared with a less intensive intervention consisting of regular daily text message health reminders, compared with the standard advice given to patients undergoing radical prostatectomy. While it is intuitive that healthier patients will feel better and have easier recoveries after radical prostatectomy, there is no existing evidence thus far to support this. The investigation will apply a single center, randomized, clinical 18 month study design and employ validated instruments to assess health related quality of life status, EF and urinary continence.

The study design will be a single center, randomized, clinical 3-arm study, comparing the effects of an intensive lifestyle intervention based on the Look AHEAD regimen vs. a less intensive text message intervention vs. standard lifestyle advice typically provided prior to radical prostatectomy. For the control arm, participants will complete post-operative assessments at months 3, 6, 12 and 18 where they will repeat the baseline questionnaires and measures. Please note that for all recruited patients who are not local, the follow-up questionnaires will be obtained via mail, and the physical parameters will be derived from direct contact with the patient's local care provider. In the event that this is not possible, we will rely on patient self-report. Standard practice associated with surgery and postoperative laboratory testing will be performed. Patients may use a phosphodiesterase type 5 inhibitor (sildenafil, tadalafil or vardenafil) following surgery as conventional "on-demand" therapy for erectile dysfunction (ED).