Quality of Life Study Using Gabapentin Versus Venlafaxine in Treating Hot Flashes in Patients With Prostate Cancer

60 evaluable patients with prostate cancer currently receiving androgen ablation therapy or
who have had an orchiectomy will be enrolled in this study. All patients will be
randomized 1:1 (30 patients per treatment arm) to either receive gabapentin or venlafaxine.
Treatment duration will be a total of 6 months. During those 6 months, study staff will
evaluate frequency and intensity of hot flashes using hot flash score from hot flash diary
every 28 days. Patients will also record side effects associated with either gabapentin or
venlafaxine on their medication diaries. Study staff will record the severity of all adverse
events reported. Patients will also complete the quality of life Functional Assessment of
Cancer Therapy-Prostate (FACT-P) form at baseline, cycle 3, and cycle 6/off study.

Inclusion Criteria:

- Men 18 years or older with histologically proven adenocarcinoma of the prostate

- Prior or current androgen deprivation for at least 6 months prior to study entry with
either bilateral orchiectomy or being maintained on a stable dose of LHRH
(luteinizing hormone-releasing hormone) agonist or antagonist

- Hot flash frequency of an average of 2 or more per day (average of 14 hot flash
episodes per week)

Exclusion Criteria:

- cannot currently be taking serotonin reuptake inhibitors (SSRIs),
serotonin-norepinephrine reuptake inhibitors (SNRIs) or monoamine oxidase inhibitors
(MAOIs)

- cannot have uncontrolled hypertension

- cannot have history of past or current of epilepsy, epilepsy syndrome or other
seizure disorder

- cannot have psychiatric history of mania, hypomania, bipolar disorder or
anorexia nervosa

- cannot be receiving concurrent treatment with amy medications or herbal products
being used with the express purpose of treating hot flashes.