A Study of Tadalafil After Radical Prostatectomy

Official Title: “A Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Effect on Unassisted Erectile Function of the Early Use of Tadalafil 5 mg Once a Day and Tadalafil 20 mg On Demand Treatment for 9 Months in Subjects Undergoing Bilateral Nerve-Sparing Radical Prostatectomy”

The study will include patients with localized prostate cancer who experience erectile dysfunction following bilateral nerve-sparing radical prostatectomy. Patients will be randomly assigned to three treatment arms: Tadalafil 5 mg once a day, Tadalafil 20 mg on demand (prior to anticipated sexual activity), and placebo. Patients will stay on therapy for 9 months and after withdrawal of medication for 6 weeks, patients will be evaluated for recovery of unassisted erectile function (without medication). An open-label extension for three months will evaluate the responsiveness of all patients to Tadalafil 5 mg once a day.

Further objectives are to evaluate the treatment satisfaction of the respective therapies.

Intervention(s) in this Clinical Trial

• Drug: Tadalafil
  • Administered by mouth for 9 months
• Drug: Placebo
  • Administered by mouth, daily or on demand for 9 months

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Tadalafil daily (5mg)
  • After the treatment period and 6 week study drug free period, all participants can continue on study in an optional 5mg tadalafil 3 month open label period.
• Experimental: Tadalafil on demand (20mg)
  • After the treatment period and 6 week study drug free period, all participants can continue on study in an optional 5mg tadalafil 3 month open label period.
• Placebo Comparator: Placebo
  • After the treatment period and 6 week study drug free period, all participants can continue on study in an optional 5mg tadalafil 3 month open label period.

Primary Measures

• Percentage of subjects with a score of greater than or equal to 22 in the Erectile Function (EF) Domain of the International Index of Erectile Function (IIEF) questionnaire
  • Time Frame: Randomization to end of 6 weeks of study drug free washout
    Safety Issue?: No

Secondary Measures

• Percentage of subjects with a score of greater than or equal to 22 in the IIEF-EF Domain
  • Time Frame: Randomization to end of 9 months of treatment, end of 3 months open-label treatment
    Safety Issue?: No
• Change from baseline to endpoint in IIEF-EF total score
  • Time Frame: Randomization to end of 9 months of treatment, end of 6 weeks of study drug free washout, end of 3 month open label treatment
    Safety Issue?: No
• Change from baseline to endpoint in IIEF domains (Intercourse Satisfaction Domain, Orgasmic Function Domain, Sexual Desire Domain, Overall Satisfaction Domain)
  • Time Frame: Randomization to end of 9 months of treatment, end of 6 weeks of study drug free washout, end of 3 month open label treatment
    Safety Issue?: No
• Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) questionnaire summary score
  • Time Frame: End of 9 months of treatment, end of 3 month open label treatment
    Safety Issue?: No
• Change from baseline in Self Esteem and Relationship (SEAR) questionnaire score
  • Time Frame: Randomization, 2 months, 5 months, end of 9 months of treatment, end of 3 month open label treatment
    Safety Issue?: No
• Global Assessment Questions (GAQ) 1 and 2
  • Time Frame: End of 9 month treatment, end of 3 month open label treatment
    Safety Issue?: No
• Residual Erectile Function (REF)
  • Time Frame: Randomization, 2 months, 5 months, end of 9 months treatment, end of 6 week study drug free washout, end of 3 month open label treatment
    Safety Issue?: No
• Change from baseline in 'yes' answers to questions 1 to 5 of the Sexual Encounter Profile (SEP)
  • Time Frame: Randomization to end of 9 months of treatment, end of 6 weeks of study drug free washout, end of 3 month open label treatment
    Safety Issue?: No
• Change from baseline in 'yes' answers to morning erections
  • Time Frame: Randomization to end of 6 week study drug free washout
    Safety Issue?: No
• Standardised Morning Erections Question score
  • Time Frame: 2 months, 5 months, end of 9 months treatment, end of 3 month open label treatment
    Safety Issue?: No
• Change from baseline in 26-item Expanded Prostate Cancer Index Composite (EPIC-26) questionnaire score
  • Time Frame: Randomization to end of 9 months of treatment, end of 3 month open label treatment
    Safety Issue?: No
• Change in penile length and girth (cm)
  • Time Frame: Randomization to end of 9 months treatment
    Safety Issue?: No

Inclusion Criteria:

• scheduled to undergo Bilateral nerve-sparing radical prostatectomy (BNSRP) for organ-confined, non-metastatic prostate cancer
• have a normal preoperative erectile function score of more or equal to 22 at screening(as evaluated by International Index of Erectile Function - Erectile
• Function domain (IIEF-EF))
• develop Erectile Dysfunction (ED) (defined as the consistent inability to achieve and/or maintain an erection sufficient to permit satisfactory sexual intercourse) after surgery
• have an interest in resuming sexual activity as soon as possible after surgery and anticipate having the same adult female sexual partner during the study
• agree not to use any other treatment for ED, including herbal and over-the-counter (OTC) medications, during the study
• does not require the initiation of adjuvant therapy for prostate cancer

Exclusion Criteria:

• history of ED
• have received previous or current treatment with tadalafil or any other PDE5 (Phosphodiesterase Type 5) inhibitor
• have undergone, or plan to undergo, radiation or hormonal therapy for prostate cancer
• have a history of prostatic surgery or prostatic physical treatments
• have a history of diabetes mellitus
• have a history of galactose intolerance, lapp lactase deficiency, or glucose-galactose malabsorption
• have clinically significant renal insufficiency as determined by the investigator

Gender Eligibility for this Clinical Trial: Male

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 67 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Eli Lilly and Company Industry

Overall Clinical Trial Officials and Contacts

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Study Director Eli Lilly and Company  

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT01026818

Study ID Number: 13086

ClinicalTrials.gov Identifier: NCT01026818

Health Authority: Germany: Federal Institute for Drugs and Medical Devices