A Study of Tadalafil After Radical Prostatectomy (REACTT)
2013년 12월 12일 업데이트: Eli Lilly and Company
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.
연구 개요
연구 유형
중재적
등록 (실제)
583
단계
- 4단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Amsterdam, 네덜란드, 1066 CX
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Leiden, 네덜란드, 2300 RC
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Nijmegen, 네덜란드, 6532 SZ
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Rotterdam, 네덜란드, 3045 PM
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S-Hertogenbosch, 네덜란드, 5211 NL
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Veldhoven, 네덜란드, 5504 DB
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Berlin, 독일, 12203
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Braunschweig, 독일, 38126
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Dresden, 독일, 01307
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Essen, 독일, 45122
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Hamburg, 독일, 20246
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Hannover, 독일, 30625
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Herne, 독일, 44627
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Leipzig, 독일, 04103
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Leverkusen, 독일, 51375
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Kortrijk, 벨기에, 8500
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Leuven, 벨기에, 3000
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Liège, 벨기에, 4000
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Basel, 스위스, CH-4031
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Luzern, 스위스, CH-6000
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Zurich, 스위스, CH-8091
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Aravaca, 스페인, 28023
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Cordoba, 스페인, 14004
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Madrid, 스페인, 28046
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Majadahonda, 스페인, 28222
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Málaga, 스페인, 29010
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Sevilla, 스페인, 41013
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Valencia, 스페인, 46010
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Cambridgeshire
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Cambridge, Cambridgeshire, 영국, CB2 0QQ
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Cleveland
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Middlesbrough, Cleveland, 영국, TS4 3BW
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Herts
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Stevenage, Herts, 영국, SG4 7NH
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Manchester
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Withington, Manchester, 영국, M20 9BX
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Acquavivadellefonti, 이탈리아, 70021
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Bergamo, 이탈리아, 24128
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Bologna, 이탈리아, 40138
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Genova, 이탈리아, 16132
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Milano, 이탈리아, 20132
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Perugia, 이탈리아, 06122
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Alberta
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Calgary, Alberta, 캐나다, T2W 1P9
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British Columbia
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Victoria, British Columbia, 캐나다, V8T 5G1
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Ontario
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London, Ontario, 캐나다, N6A 4V2
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Bydgoszcz, 폴란드, 85-168
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Gdansk, 폴란드, 80-952
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Kielce, 폴란드, 25-734
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Warsaw, 폴란드, 02-005
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Zabrze, 폴란드, 41-800
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Creteil, 프랑스, 94010
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Grenoble, 프랑스, 38043
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Lyon, 프랑스, 69437
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Nice, 프랑스, 06002
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Nimes, 프랑스, 30029
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Pierre Benite, 프랑스, 69495
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
남성
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Tadalafil daily [5 milligrams (mg)]
After the treatment period and 6-week study Drug-Free Period, all participants can continue on study in an optional 5-mg tadalafil 3-month Open-Label Period.
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Administered by mouth for 9 months
다른 이름들:
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실험적: Tadalafil on demand (20 mg)
After the treatment period and 6-week study Drug-Free Period, all participants can continue on study in an optional 5-mg tadalafil 3-month Open-Label Period.
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Administered by mouth for 9 months
다른 이름들:
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위약 비교기: Placebo
After the treatment period and 6-week study Drug-Free Period, all participants can continue on study in an optional 5-mg tadalafil 3-month Open-Label Period.
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Administered by mouth, daily or on demand for 9 months
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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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
기간: Month 10.5
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Self-reported erectile function during the past 4 weeks.
IIEF- EF is the sum of Questions 1-5 and 15 of the IIEF.
Questions 1-5 are scored 0 (no sexual activity for Question 1, no sexual stimulation for Question 2 and did not attempt intercourse for Questions 3-5) to 5 (high erectile function) and Question 15 is scored 1 (very low confidence) to 5 (very high confidence), for a total score ranging from 1 to 30.
Higher scores represent better erectile function.
Data presented are the percentage of participants with an IIEF-EF Total Score greater than or equal to (≥) 22.
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Month 10.5
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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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
기간: Month 9 and Month 13.5
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Self-reported erectile function during the past 4 weeks.
IIEF- EF is the sum of Questions 1-5 and 15 of the IIEF.
Questions 1-5 are scored 0 (no sexual activity for Question 1, no sexual stimulation for Question 2 and did not attempt intercourse for Questions 3-5) to 5 (high erectile function) and Question 15 is scored 1 (very low confidence) to 5 (very high confidence), for a total score ranging from 1 to 30.
Higher scores represent better erectile function.
Data presented are the percentage of participants with an IIEF-EF Total Score greater than or equal to (≥) 22.
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Month 9 and Month 13.5
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Change From Baseline to Endpoint in the International Index of Erectile Function- Erectile Function (IIEF-EF) Total Score
기간: Randomization (Baseline), Months 9 and 10.5 and 13.5
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Self-reported erectile function during the past 4 weeks.
IIEF- EF is the sum of Questions 1-5 and 15 of the IIEF.
Questions 1-5 are scored 0 (no sexual activity for Question 1, no sexual stimulation for Question 2 and did not attempt intercourse for Questions 3-5) to 5 (high erectile function) and Question 15 is scored 1 (very low confidence) to 5 (very high confidence), for a total score ranging from 1 to 30.
Higher scores represent better erectile function.
The Mixed Model for Repeated Measures (MMRM) analysis was used to calculate Least Squares (LS) mean and 95% confidence interval (CI).
LS mean values are adjusted for baseline score, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p<0.10).
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Randomization (Baseline), Months 9 and 10.5 and 13.5
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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)
기간: Randomization (Baseline), Months 9 and 10.5 and 13.5
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Self-reported overall satisfaction during past 4 weeks.
Orgasmic function score is sum of Questions (Q)9 and 10 of IIEF.
Scores range from 0 (no sexual stimulation or intercourse) to 5 (high orgasm) for each Q, total 0 to 10. Sexual desire score is sum of Q11 and 12 of IIEF.
Scores range from 1 (low/no desire) to 5 (high desire) for each Q, total 2 to 10. Intercourse satisfaction score is sum of Q6, 7 and 8 of IIEF.
Scores range from 0 (no attempts for Q6, did not attempt intercourse for Q7 and no intercourse for Q8) to 5 (high satisfaction) for each Q, total 0 to 15. Overall satisfaction score is sum of Q13 and 14 of IIEF.
Scores range from 1 (low/no satisfaction) to 5 (high satisfaction) for each Q, total 2 to 10. Higher total scores for each domain indicate higher function.
MMRM analysis was used to calculate LS mean and 95% CI.
LS mean values are adjusted for baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p<0.10).
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Randomization (Baseline), Months 9 and 10.5 and 13.5
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Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Questionnaire Mean Score
기간: Months 9 and 13.5
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The EDITS questionnaire is a validated questionnaire consisting of 11 questions evaluating self-reported satisfaction with the erectile dysfunction (ED) treatment.
Responses were based on the experiences during the previous 4 weeks.
Each question is rated on a scale of 0 (extremely low treatment satisfaction) to 4 (extremely high treatment satisfaction).
The EDITS mean score was obtained by adding each individual result for all questions, dividing by the number of questions answered.
The mean scores range from 0 (extremely low treatment satisfaction) to 4 (extremely high satisfaction).
The Mixed Model for Repeated Measures (MMRM) analysis was used to calculate Least Squares (LS) mean and 95% Confidence Interval (CI).
LS mean values are adjusted for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p<0.10).
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Months 9 and 13.5
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Change From Baseline in Self Esteem and Relationship (SEAR) Questionnaire Score
기간: Randomization (Baseline), Months 9 and 13.5
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The SEAR questionnaire is a participant-reported measure of psychosocial outcomes in men with erectile dysfunction (ED).
It consists of 14 items.
Sexual Relationship domain consists of 8 items (items 1-8).
Items 2-8 are rated on a scale of 1 (Never) to 5 (Always), whereas item 1 is reverse scored (1=Always and 5=Never).
The total scores for sexual relationship domain range from 8-40 with higher scores indicating better relationship.
Self-Esteem subdomain contains items 9 through 12 rated on a scale of 1 (no/low self-esteem) to 5 (high self-esteem).
Total scores for Self-Esteem subscale range from 4-20 with higher scores indicating higher self-esteem.
The Mixed Model for Repeated Measures (MMRM) analysis was used to calculate Least Squares (LS) mean and 95% Confidence Interval (CI).
LS mean values are adjusted for baseline domain score, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p<0.10).
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Randomization (Baseline), Months 9 and 13.5
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Global Assessment Questions (GAQ) Question 1 at Month 9
기간: Month 9
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GAQ Question 1: Choose the one number which best describes how you perceive your ability to achieve and maintain your erections now, compared to how it was before you began taking medication in this study.
Responses range from very much better (1) to very much worse (7).
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Month 9
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Global Assessment Question (GAQ) Question 1 at Month 13.5
기간: Month 13.5
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GAQ Question 1: Choose the one number which best describes how you perceive your ability to achieve and maintain your erections now, compared to how it was before you began taking medication in this study.
Responses range from very much better (1) to very much worse (7).
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Month 13.5
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Global Assessment Question (GAQ) Question 2 at Month 9
기간: Month 9
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GAQ Question 2: Choose the one number which best describes how you perceive your sexual life is now, compared to how it was before you began taking medication in this study.
Responses range from very much better (1) to very much worse (7).
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Month 9
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Global Assessment Question (GAQ) Question 2 at Month 13.5
기간: Month 13.5
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GAQ Question 2: Choose the one number which best describes how you perceive your sexual life is now, compared to how it was before you began taking medication in this study.
Responses range from very much better (1) to very much worse (7).
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Month 13.5
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Residual Erectile Function (REF) at Baseline
기간: Baseline
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The participant is asked to rate the hardness of his erection using a 5-point grading system, with 0 (penis does not enlarge), 1 (penis is larger but not hard), 2 (penis is hard but not enough for penetration), 3 (penis is hard enough for penetration but not completely hard), 4 (penis is completely hard and fully rigid.)
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Baseline
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Residual Erectile Function (REF) at Month 2
기간: Month 2
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The participant is asked to rate the hardness of his erection using a 5-point grading system, with 0 (penis does not enlarge), 1 (penis is larger but not hard), 2 (penis is hard but not enough for penetration), 3 (penis is hard enough for penetration but not completely hard), 4 (penis is completely hard and fully rigid.)
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Month 2
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Residual Erectile Function (REF) at Month 5
기간: Month 5
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The participant is asked to rate the hardness of his erection using a 5-point grading system, with 0 (penis does not enlarge), 1 (penis is larger but not hard), 2 (penis is hard but not enough for penetration), 3 (penis is hard enough for penetration but not completely hard), 4 (penis is completely hard and fully rigid.)
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Month 5
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Residual Erectile Function (REF) at Month 9
기간: Month 9
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The participant is asked to rate the hardness of his erection using a 5-point grading system, with 0 (penis does not enlarge), 1 (penis is larger but not hard), 2 (penis is hard but not enough for penetration), 3 (penis is hard enough for penetration but not completely hard), 4 (penis is completely hard and fully rigid.)
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Month 9
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Residual Erectile Function (REF) at Month 10.5
기간: Month 10.5
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The participant is asked to rate the hardness of his erection using a 5-point grading system, with 0 (penis does not enlarge), 1 (penis is larger but not hard), 2 (penis is hard but not enough for penetration), 3 (penis is hard enough for penetration but not completely hard), 4 (penis is completely hard and fully rigid.)
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Month 10.5
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Residual Erectile Function (REF) at Month 13.5
기간: Month 13.5
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The participant is asked to rate the hardness of his erection using a 5-point grading system, with 0 (penis does not enlarge), 1 (penis is larger but not hard), 2 (penis is hard but not enough for penetration), 3 (penis is hard enough for penetration but not completely hard), 4 (penis is completely hard and fully rigid.)
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Month 13.5
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Change From Baseline in 'Yes' Answers to Questions 1 to 5 of the Sexual Encounter Profile (SEP)
기간: Randomization (Baseline), Months 9 and 10.5 and 13.5
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Participant-assessed diary has 5 questions: Question (Q)1: erection achievement, Q2: successful penetration, Q3: successful intercourse, Q4: satisfied with erection, and Q5: satisfied with sexual experience) for each sexual encounter made over a specified period of time.
SEP Q1-Q5 scores were determined as the percentage of 'Yes' responses to each of the 5 questions out of all sexual attempts recorded during the time period.
The Mixed Model for Repeated Measures (MMRM) analysis was used to calculate Least Squares (LS) mean and 95% confidence interval (CI).
LS mean values are adjusted for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p<0.10).
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Randomization (Baseline), Months 9 and 10.5 and 13.5
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Change From Baseline in 'Yes' Answers to Morning Erections
기간: Randomization (Baseline), Month 10.5
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The participants were asked to complete the morning erections diary every morning during the 4-week period before randomization and during the 6-week, Drug-Free, Washout Period.
Data presented are the changes in the participant's percentage of "yes" responses relative to the number of days the question was answered during treatment.
The analysis of covariance (ANCOVA) was used to calculate Least Square (LS) mean and 95% confidence interval (CI).
LS mean values are adjusted for treatment, baseline morning erections frequency, age group and country.
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Randomization (Baseline), Month 10.5
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Standardized Morning Erections Question (SMEQ) Score at Month 2
기간: Month 2
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Participants evaluated the frequency of their morning erections during the past 3-month period by answering the SMEQ ("Do you ever wake up with an erection") using a 4-point grading system ranging from 0 (Yes, regularly) to 3 (never).
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Month 2
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Standardized Morning Erections Question (SMEQ) Score at Month 9
기간: Month 9
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Participants evaluated the frequency of their morning erections during the past 3-month period by answering the SMEQ ("Do you ever wake up with an erection") using a 4-point grading system ranging from 0 (Yes, regularly) to 3 (never).
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Month 9
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Standardized Morning Erections Question (SMEQ) Score at Month 13.5
기간: Month 13.5
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Participants evaluated the frequency of their morning erections during the past 3-month period by answering the SMEQ ("Do you ever wake up with an erection") using a 4-point grading system ranging from 0 (Yes, regularly) to 3 (never).
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Month 13.5
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Change From Baseline in 26-item Expanded Prostate Cancer Index Composite (EPIC-26) Questionnaire Score
기간: Randomization (Baseline), Months 9 and 13.5
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EPIC-26 (participants) contains 26 items and 5 domains: Urinary Incontinence (Items 1-4), Urinary Irritative/Obstructive (Items 5-8), Bowel (Items 10-15), Sexual (Items 16-21), and Hormonal (Items 22-26).
Response options for each EPIC item form a Likert scale, and multi-item scale scores are transformed linearly to a 0 to 100 scale for each domain, with higher scores representing better health-related quality of life.
Responses are based on experiences during the previous 4 weeks.
The Mixed Model for Repeated Measures (MMRM) analysis was used to calculate Least Squares (LS) mean and 95% confidence interval (CI).
LS mean values are adjusted for baseline domain score, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p<0.10).
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Randomization (Baseline), Months 9 and 13.5
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Change in Penile Length and Girth
기간: Randomization (Baseline), Month 9
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Measurements were performed with the penis in the flaccid state.
The stretched penile length was measured from the tip of the glans to the pubopenile skin junction while applying tension to maximally stretch the penis.
The penile circumference at midshaft was measured.
All measurements were taken with a paper ruler to the nearest 0.5 centimeter (cm).
The analysis of covariance (ANCOVA) was used to calculate Least Square (LS) mean and 95% confidence interval (CI).
LS mean values are adjusted for treatment, baseline, age group and country.
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Randomization (Baseline), Month 9
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- Montorsi F, Oelke M, Henneges C, Brock G, Salonia A, d'Anzeo G, Rossi A, Mulhall JP, Buttner H. Exploratory Decision-Tree Modeling of Data from the Randomized REACTT Trial of Tadalafil Versus Placebo to Predict Recovery of Erectile Function After Bilateral Nerve-Sparing Radical Prostatectomy. Eur Urol. 2016 Sep;70(3):529-37. doi: 10.1016/j.eururo.2016.02.036. Epub 2016 Mar 3.
- Patel HR, Ilo D, Shah N, Cuzin B, Chadwick D, Andrianne R, Henneges C, Barry J, Hell-Momeni K, Branicka J, Buttner H. Effects of tadalafil treatment after bilateral nerve-sparing radical prostatectomy: quality of life, psychosocial outcomes, and treatment satisfaction results from a randomized, placebo-controlled phase IV study. BMC Urol. 2015 Apr 12;15:31. doi: 10.1186/s12894-015-0022-9.
- Montorsi F, Brock G, Stolzenburg JU, Mulhall J, Moncada I, Patel HR, Chevallier D, Krajka K, Henneges C, Dickson R, Buttner H. Effects of tadalafil treatment on erectile function recovery following bilateral nerve-sparing radical prostatectomy: a randomised placebo-controlled study (REACTT). Eur Urol. 2014 Mar;65(3):587-96. doi: 10.1016/j.eururo.2013.09.051. Epub 2013 Oct 13.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2009년 11월 1일
기본 완료 (실제)
2012년 10월 1일
연구 완료 (실제)
2012년 10월 1일
연구 등록 날짜
최초 제출
2009년 12월 3일
QC 기준을 충족하는 최초 제출
2009년 12월 3일
처음 게시됨 (추정)
2009년 12월 4일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2014년 1월 14일
QC 기준을 충족하는 마지막 업데이트 제출
2013년 12월 12일
마지막으로 확인됨
2013년 12월 1일
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- 13086
- H6D-EW-LVIK (기타 식별자: Eli Lilly and Company)
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .