Conditions: Erectile Dysfunction Prostate Cancer
Keywords: Treatment effectiveness Treatment efficacy Investigational, Therapies Immunosuppressant Erectile dysfunction Prostatectomy
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 131
Healthy volunteers: no

Brief summary:
The purpose of the study is to compare the safety and effectiveness of Prograf in the prevention of erectile dysfunction in men after a radical prostatectomy.

Detailed description:
The purpose of the study is to compare the safety and efficacy of Prograf versus placebo in the prevention of erectile dysfunction in men after a bilateral nerve-sparing radical prostatectomy.

Arms:
arm 1: Preoperatively: Tacrolimus 2 mg oral daily from 4 to 10 days prior to surgery through hospital discharge; Postoperatively: Tacrolimus 3 mg oral daily at time of hospital discharge through 6 months of follow up. arm 2: Preoperatively: Matching placebo oral daily from 4 to 10 days prior to surgery through hospital discharge; Postoperatively: Matching placebo oral daily at time of hospital discharge through 6 months of follow up.

Interventions: intervention 1: Tacrolimus intervention 2: Placebo
Intervention descriptions: intervention 1: oral intervention 2: oral

Protocol document: