EMPOWER Men to Reduce Weight and Inhibit Prostate Cancer Progression

Korábbi kezelés

• Prior or planned bariatric surgery
• Use of prescription weight loss medication (including off label use of medications) or over-the-counter orlistat within 6 months
• Chronic use (at least past 6 months) of medications likely to cause weight gain or prevent weight loss (e.g. corticosteroids, lithium, olanzapine, risperidone, clozapine), including androgen deprivation therapy

Más betegség

• Any clinical or radiographic evidence of metastatic disease by computed tomography (CT) of the chest, abdomen and pelvis and technetium-99 bone scintigraphy (bone scan)
• MI, stroke or ASCVD procedure within 6 months
• Serious medical condition likely to hinder accurate measurement of weight, or for which weight loss is contraindicated, or which would cause weight loss
• Unstable angina or medical conditional that would prevent routine exercise

Egyéb

• Unintentional or intentional weight loss within 6 months of enrollment (≥ 5% of body weight)

• Understand and voluntarily sign consent form
• Able to adhere to study protocol
• Demonstrated use of internet and email
• Access to internet at least 4 days per week
• Willingness to change diet, physical activity and weight
• Willingness to be randomized to immediate start or standard of care
• Histologically confirmed diagnosis of adenocarcinoma of the prostate with evidence of biochemical recurrence following local therapy (surgery and radiation will be allowed). Biochemical recurrence will be defined as a PSA >= 0.2 ng/mL.
• Surgically treated men must not be eligible for or decline salvage radiation. Men who recurred within 3 years of completion of salvage radiation will be included.
• Definitive therapy (surgery or radiation) should be at least 4 weeks from time of consent.
• Men who received prior hormone therapy with definitive local therapy (standard with radiation) are permitted if serum testosterone level is >150 ng/dL and hormone treatment was discontinued > 1 year from time of enrollment.
• Body mass index >= 25 kg/m2
• Eastern Cooperative Oncology Group (ECOG) performance status < 2
• Willingness to return for clinical visit at 6 months, 12 months, and 24 months
• Men receiving testosterone replacement therapy will be included if they are on a stable dose with testosterone levels in the normal range.