A Safety and Efficacy Study of Prograf in the Prevention of Erectile Dysfunction After Radical Prostatectomy

Astellas

Status and phase: Completed; Phase 4

Conditions: Erectile Dysfunction; Prostate Cancer

Treatments: Drug: Tacrolimus; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00106392

20-03-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 131 patients

Sex: Male

Ages: Under 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male scheduled to undergo bilateral nerve sparing radical prostatectomy for prostate cancer.

Exclusion criteria

• Patient is > 65 years of age
• Patient has been diagnosed with Type 1 or Type 2 diabetes
• Patient is actively smoking on a daily basis

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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131 participants in 2 patient groups, including a placebo group

Tacrolimus

Experimental group

Description:

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.

Treatment:

Drug: Tacrolimus

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo