Phase 4
N=131
A Safety and Efficacy Study of Prograf in the Prevention of Erectile Dysfunction After Radical Prostatectomy
Erectile Dysfunction · Prostate Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00106392 ↗Enrolled (actual)
131
Serious AEs
0.8%
Results posted
Oct 2010
Primary outcome: Primary: Erectile Function Domain Score Between Treated and Untreated Groups — 18.0; 23.5 Erectile Function Domain Score — p=0.111
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Tacrolimus (Drug); Placebo (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- Male
- Sponsor
- Astellas Pharma Inc
- Primary completion
- Apr 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Erectile Function Domain Score Between Treated and Untreated Groups |
18.0; 23.5 | 0.111 |
| SECONDARY Percentage of Patients Achieving Normal Spontaneous Erectile Function as Measured by the Erectile Function (EF) Domain Score |
45.3; 54.1 | 0.453 |
| SECONDARY Time Taken to Achieve Normalization of the Erectile Function (EF) Domain Score |
104.5; 180.0 | 0.790 |
| SECONDARY Percentage of Patients Considered Successful Responders to Impotence Medications |
73.1; 86.2 | 0.099 |
| SECONDARY Time to Achieve Response to Impotence Medications |
102.0; 113.5 | 0.575 |
| SECONDARY Continence Level as Quantified by Part I of the Prostate Health-Related Quality of Life Questionnaire |
22.0; 22.0 | 0.879 |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00106392). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.