Clinical trial · Interventional
A Safety and Efficacy Study of Prograf in the Prevention of Erectile Dysfunction After Radical Prostatectomy
A Randomized, Double-blind, Placebo-controlled Study to Assess the Safety and Efficacy of Prograf (Tacrolimus, FK 506) for the Prevention of Erectile Dysfunction Following Bilateral Nerve-sparing Radical Prostatectomy
NCT00106392CI-TRIAL-00004127completedPhase 4Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Erectile Dysfunction | — | UNRESOLVED | — |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Placebo | Drug | — | UNRESOLVED |
| Tacrolimus | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Tacrolimus
- 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.
- interventionNames
- Drug: Tacrolimus
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- 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.
- interventionNames
- Drug: Placebo
Primary outcomes (1)
- measure
- Erectile Function Domain Score Between Treated and Untreated Groups
Eligibility
Eligibility (as posted)
- Sex
- Male
- Maximum age
- 65 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDMulhall JP, Klein EA, Slawin K, Henning AK, Scardino PT. A Randomized, Double-Blind, Placebo-Controlled Trial to Assess the Utility of Tacrolimus (FK506) for the Prevention of Erectile Dysfunction Following Bilateral Nerve-Sparing Radical Prostatectomy. J Sex Med. 2018 Sep;15(9):1293-1299. doi: 10.1016/j.jsxm.2018.07.009. PMID 30224019