Phase 4
N=583
A Study of Tadalafil After Radical Prostatectomy
Erectile Dysfunction
Bottom Line
View on ClinicalTrials.gov: NCT01026818 ↗Enrolled (actual)
583
Serious AEs
1.8%
Results posted
Nov 2013
Primary outcome: Primary: Percentage of Participants 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 — 20.9; 16.9; 19.1 percentage of participants — p=0.675
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Tadalafil (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Eli Lilly and Company
- Primary completion
- Oct 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants 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 |
20.9; 16.9; 19.1 | 0.675 |
| SECONDARY Percentage of Participants With a Score of Greater Than or Equal to 22 in the International Index of Erectile Function- Erectile Function (IIEF-EF) Domain |
25.2; 19.7; 14.2; 32.4; 33.1; 27.0 | 0.016 sig |
| SECONDARY Change From Baseline to Endpoint in the International Index of Erectile Function- Erectile Function (IIEF-EF) Total Score |
7.73; 6.53; 4.93; 6.24; 5.76; 5.98 | 0.007 sig |
| SECONDARY Change From Baseline to Endpoint in the International Index of Erectile Function (IIEF) Domains (Intercourse Satisfaction Domain, Orgasmic Function Domain, Sexual Desire Domain, Overall Satisfaction Domain) |
2.76; 2.48; 2.39; 2.94; 2.48; 2.48 | 0.340 |
| SECONDARY Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Questionnaire Mean Score |
2.21; 2.11; 1.88; 2.54; 2.38; 2.25 | 0.005 sig |
| SECONDARY Change From Baseline in Self Esteem and Relationship (SEAR) Questionnaire Score |
4.78; 3.50; 3.02; 6.90; 6.68; 6.72 | 0.086 |
| SECONDARY Global Assessment Questions (GAQ) Question 1 at Month 9 |
9; 10; 4; 12; 22; 9 | — |
| SECONDARY Global Assessment Question (GAQ) Question 1 at Month 13.5 |
13; 19; 16; 24; 25; 18 | — |
| SECONDARY Global Assessment Question (GAQ) Question 2 at Month 9 |
7; 7; 3; 12; 25; 11 | — |
| SECONDARY Global Assessment Question (GAQ) Question 2 at Month 13.5 |
9; 20; 14; 29; 23; 21 | — |
| SECONDARY Residual Erectile Function (REF) at Baseline |
61; 62; 64; 46; 48; 47 | — |
| SECONDARY Residual Erectile Function (REF) at Month 2 |
28; 27; 38; 38; 51; 53 | — |
| SECONDARY Residual Erectile Function (REF) at Month 5 |
12; 21; 27; 37; 39; 35 | — |
| SECONDARY Residual Erectile Function (REF) at Month 9 |
11; 17; 23; 25; 28; 35 | — |
| SECONDARY Residual Erectile Function (REF) at Month 10.5 |
13; 17; 22; 29; 30; 29 | — |
| SECONDARY Residual Erectile Function (REF) at Month 13.5 |
5; 8; 11; 19; 20; 25 | — |
| SECONDARY Change From Baseline in 'Yes' Answers to Questions 1 to 5 of the Sexual Encounter Profile (SEP) |
67.41; 63.88; 52.54; 67.78; 64.24; 58.86 | 0.008 sig |
| SECONDARY Change From Baseline in 'Yes' Answers to Morning Erections |
8.92; 12.16; 14.04 | 0.162 |
| SECONDARY Standardized Morning Erections Question (SMEQ) Score at Month 2 |
4; 7; 7; 8; 15; 10 | — |
| SECONDARY Standardized Morning Erections Question (SMEQ) Score at Month 9 |
7; 9; 7; 21; 19; 9 | — |
| SECONDARY Standardized Morning Erections Question (SMEQ) Score at Month 13.5 |
13; 15; 13; 22; 24; 18 | — |
| SECONDARY Change From Baseline in 26-item Expanded Prostate Cancer Index Composite (EPIC-26) Questionnaire Score |
34.08; 31.12; 30.59; 37.41; 35.54; 35.44 | 0.196 |
| SECONDARY Change in Penile Length and Girth |
-1.53; -7.26; -5.73; 0.03; 0.82; -2.34 | 0.028 sig |
Summary
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.
Eligibility Criteria
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 Phosphodiesterase Type 5 (PDE5) 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
Data sourced from ClinicalTrials.gov (NCT01026818). 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.