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Tadalafil in Preventing Erectile Dysfunction in Patients With Prostate Cancer Treated With Radiation Therapy

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ClinicalTrials.gov Identifier: NCT00931528
Recruitment Status : Completed
First Posted : July 2, 2009
Results First Posted : July 27, 2016
Last Update Posted : February 14, 2018
Sponsor:
Collaborators:
National Cancer Institute (NCI)
NRG Oncology
Information provided by (Responsible Party):
Radiation Therapy Oncology Group

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Supportive Care
Conditions Prostate Cancer
Sexual Dysfunction
Interventions Drug: Tadalafil
Other: Placebo
Enrollment 242
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Tadalafil Placebo
Hide Arm/Group Description Beginning ≤ 7 days after the start of radiotherapy, patients receive oral tadalafil 5mg once daily for 24 weeks. Beginning ≤ 7 days after the start of radiotherapy, patients receive oral placebo once daily for 24 weeks.
Period Title: Overall Study
Started 121 121
Completed 80 [1] 61 [1]
Not Completed 41 60
Reason Not Completed
Protocol Violation             9             12
Withdrawal by Subject             4             12
Lost to Follow-up             6             13
Assessment outside of Time Frame             22             23
[1]
Subjects with data available for the primary analysis are considered to have completed the study.
Arm/Group Title Tadalafil Placebo Total
Hide Arm/Group Description Beginning ≤ 7 days after the start of radiotherapy, patients receive oral tadalafil 5mg once daily for 24 weeks. Beginning ≤ 7 days after the start of radiotherapy, patients receive oral placebo once daily for 24 weeks. Total of all reporting groups
Overall Number of Baseline Participants 112 109 221
Hide Baseline Analysis Population Description
All randomized eligible patients.
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 112 participants 109 participants 221 participants
63
(45 to 80)
63
(48 to 79)
63
(45 to 80)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 112 participants 109 participants 221 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
112
 100.0%
109
 100.0%
221
 100.0%
1.Primary Outcome
Title Percentage of Patients Maintaining Spontaneous (Off-drug) Erectile Function (EF) at Weeks 28-30 After Initiation of Radiation Therapy (RT)
Hide Description EF is measured by Question 1 of the International Index of Erectile Function (IIEF). The IIEF is a validated 15-item for measuring patient-reported erectile function. Question 1 asks "How often were you able to get an erection during sexual activity?" Responses ranged from 0=no sexual activity, to 5=Almost always or always. Higher scores indicated better functioning. All patients have erectile function prior to initiation of RT, indicated by a score of 3, 4, or 5 on IIEF Q1. Patients with a lower IIEF Q1 score at weeks 28-30 than at baseline will have less erectile function and be categorized as nonresponders. Patients with similar or improved erectile function will be categorized as responders (maintaining). Patient-related predictors of at erectile function at this time point are also reported with this outcome measure.
Time Frame Baseline and 30 weeks from the start of radiation therapy
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized eligible patients with IIEF at both baseline and 30 week time point.
Arm/Group Title Tadalafil Placebo
Hide Arm/Group Description:
Beginning ≤ 7 days after the start of radiotherapy, patients receive oral tadalafil once daily for 24 weeks.
Beginning ≤ 7 days after the start of radiotherapy, patients receive oral placebo once daily for 24 weeks.
Overall Number of Participants Analyzed 80 61
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
79
(70 to 88)
74
(63 to 85)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tadalafil, Placebo
Comments Sample size calculations were based on the hypothesis that the use of tadalafil would statistically significant increase the proportion of patients maintaining spontaneous erectile function compared to the use of placebo. Based on a 2-sided Fisher exact test with alpha=0.05, 91 patients/arm would provide 80% statistical power to detect an increase from 20% to 40% in spontaneous erectile response at weeks 28-30. Although designed for the Fisher exact test, Chi-square was used and reported.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.49
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentages
Estimated Value 5
Confidence Interval (2-Sided) 95%
1 to 9
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tadalafil, Placebo
Comments Logistic regression using generalized estimating equations was performed modeling the probability of non-responders. Only treatment arm (Placebo vs. Tadalafil), age (> 65 vs. other), RT method (External RT vs. brachytherapy), and significant pretreatment characteristics [N stage (NX vs. N0)] were retained in the model. (Dropped: ethnicity, Zubrod, T stage, prostate-specific antigen (PSA).) The results for each explanatory variable are reported separately. Treatment arm is reported here.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2386
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Tadalafil, Placebo
Comments Logistic regression using generalized estimating equations was performed modeling the probability of non-responders. Only treatment arm (Placebo vs. Tadalafil), age (> 65 vs. other), RT method (External RT vs. brachytherapy), and significant pretreatment characteristics [N stage (NX vs. N0)] were retained in the model. (Dropped pretreatment characteristics: ethnicity, Zubrod, T stage, PSA.)The results for each explanatory variable are reported separately. RT method is reported here.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7908
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Tadalafil, Placebo
Comments Logistic regression using generalized estimating equations was performed modeling the probability of non-responders. Only treatment arm (Placebo vs. Tadalafil), age (> 65 vs. other), RT method (External RT vs. brachytherapy), and significant pretreatment characteristics [N stage (NX vs. N0)] were retained in the model. (Dropped pretreatment characteristics: ethnicity, Zubrod, T stage, PSA.) The results for each explanatory variable are reported separately. Age is reported here.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0467
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Tadalafil, Placebo
Comments Logistic regression using generalized estimating equations was performed modeling the probability of non-responders. Only treatment arm (Placebo vs. Tadalafil), age (> 65 vs. other), RT method (External RT vs. brachytherapy), and significant pretreatment characteristics [N stage (NX vs. N0)] were retained in the model. (Dropped pretreatment characteristics: ethnicity, Zubrod, T stage, PSA.) The results for each explanatory variable are reported separately. N Stage is reported here.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0068
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Patients Maintaining Spontaneous (Off-drug) EF at Years 1 and 2 After Initiation of RT
Hide Description The International Index of Erectile Function (IIEF) is a validated 15-item for measuring patient-reported erectile function. Question 1 asks "How often were you able to get an erection during sexual activity?" Responses ranged from 0=no sexual activity, to 5=Almost always or always. Higher scores indicated better functioning. All patients have erectile function prior to initiation of RT, indicated by a score of 3, 4, or 5. Patients with a lower IIEF Q1 score at weeks 28-30 than at baseline will have less erectile function and be categorized as nonresponders. Patients with similar or improved erectile function will be categorized as responders (maintaining). Patient-related predictors of at erectile function at Years 1 and 2 are also reported with this outcome measure.
Time Frame Baseline, 1 and 2 years from the start of tadalafil or placebo
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized eligible patients with IIEF at both baseline and corresponding time point.
Arm/Group Title Tadalafil Placebo
Hide Arm/Group Description:
Beginning ≤ 7 days after the start of radiotherapy, patients receive oral tadalafil once daily for 24 weeks.
Beginning ≤ 7 days after the start of radiotherapy, patients receive oral placebo once daily for 24 weeks.
Overall Number of Participants Analyzed 109 108
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Year 1 Number Analyzed 54 participants 49 participants
72.2
(60.3 to 84.1)
71.4
(58.7 to 84.1)
Year 2 Number Analyzed 57 participants 49 participants
68.4
(56.3 to 80.5)
63.3
(49.8 to 76.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tadalafil, Placebo
Comments Year 1
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.93
Comments [Not Specified]
Method Chi-squared
Comments 2-sided significance level = 0.05
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tadalafil, Placebo
Comments Year 2
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.58
Comments [Not Specified]
Method Chi-squared
Comments 2-sided significance level = 0.05
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Tadalafil, Placebo
Comments Year 1: Logistic regression using generalized estimating equations was performed modeling the probability of non-responders. Only treatment arm (Placebo vs. Tadalafil), age (> 65 vs. other), RT method (External RT vs. brachytherapy), and significant pretreatment characteristics [none] were retained in the model. (Dropped pretreatment characteristics: ethnicity, Zubrod, N stage, T stage, PSA.) The results for each explanatory variable are reported separately. Treatment arm is reported here.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9501
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Tadalafil, Placebo
Comments Year 1: Logistic regression using generalized estimating equations was performed modeling the probability of non-responders. Only treatment arm (Placebo vs. Tadalafil), age (> 65 vs. other), RT method (External RT vs. brachytherapy), and significant pretreatment characteristics [none] were retained in the model. (Dropped pretreatment characteristics: ethnicity, Zubrod, N stage, T stage, PSA.) The results for each explanatory variable are reported separately. RT method is reported here.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1020
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Tadalafil, Placebo
Comments Year 1: Logistic regression using generalized estimating equations was performed modeling the probability of non-responders. Only treatment arm (Placebo vs. Tadalafil), age (> 65 vs. other), RT method (External RT vs. brachytherapy), and significant pretreatment characteristics [none] were retained in the model. (Dropped pretreatment characteristics: ethnicity, Zubrod, N stage, T stage, PSA.) The results for each explanatory variable are reported separately. Age is reported here.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1855
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Tadalafil, Placebo
Comments Year 2: Logistic regression using generalized estimating equations was performed modeling the probability of non-responders. Only treatment arm (Placebo vs. Tadalafil), age (> 65 vs. other), RT method (External RT vs. brachytherapy), and significant pretreatment characteristics [N stage (NX)] were retained in the model. (Dropped pretreatment characteristics: ethnicity, Zubrod, T stage, PSA.) The results for each explanatory variable are reported separately. Treatment arm is reported here.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5739
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Tadalafil, Placebo
Comments Year 2: Logistic regression using generalized estimating equations was performed modeling the probability of non-responders. Only treatment arm (Placebo vs. Tadalafil), age (> 65 vs. other), RT method (External RT vs. brachytherapy), and significant pretreatment characteristics [N stage (NX)] were retained in the model. (Dropped pretreatment characteristics: ethnicity, Zubrod, T stage, PSA.) The results for each explanatory variable are reported separately. RT method is reported here.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0422
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Tadalafil, Placebo
Comments Year 2: Logistic regression using generalized estimating equations was performed modeling the probability of non-responders. Only treatment arm (Placebo vs. Tadalafil), age (> 65 vs. other), RT method (External RT vs. brachytherapy), and significant pretreatment characteristics [N stage (NX)] were retained in the model. (Dropped pretreatment characteristics: ethnicity, Zubrod, T stage, PSA.) The results for each explanatory variable are reported separately. Age is reported here.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5237
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Tadalafil, Placebo
Comments Year 2: Logistic regression using generalized estimating equations was performed modeling the probability of non-responders. Only treatment arm (Placebo vs. Tadalafil), age (> 65 vs. other), RT method (External RT vs. brachytherapy), and significant pretreatment characteristics [N stage (NX)] were retained in the model. (Dropped pretreatment characteristics: ethnicity, Zubrod, T stage, PSA.) The results for each explanatory variable are reported separately. N Stage is reported here.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4770
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
3.Secondary Outcome
Title Overall Sexual Function as Measured by Change From Baseline in the International Index of Erectile Function (IIEF)
Hide Description The IIEF is a validated 15-item for measuring patient-reported erectile function. A score of 0-5 is given to each of the 15 questions that examine 5 main domains of male sexual function: erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction. Domain scores are the sum of each item. The erectile function domain has 5 items with a score range of 1-30, orgasmic function has 2 items with a score range of 0-10, sexual desire has 2 items with a score range of 0-10, intercourse satisfaction has 3 items with a score range of 0-15, and overall satisfaction has 2 items with a score range of 2-10. Total score ranges from 0-70, with higher scores indicated better functioning. Change from baseline is calculated by subtracting baseline score from score at the time point of interest.
Time Frame Baseline, week 30, and years 1 and 2 from start of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients with IIEF at baseline and corresponding time points.
Arm/Group Title Tadalafil Placebo
Hide Arm/Group Description:
Beginning ≤ 7 days after the start of radiotherapy, patients receive oral tadalafil 5mg once daily for 24 weeks.
Beginning ≤ 7 days after the start of radiotherapy, patients receive oral placebo once daily for 24 weeks.
Overall Number of Participants Analyzed 109 108
Mean (Standard Deviation)
Unit of Measure: change in total IIEF
Week 30 Number Analyzed 70 participants 58 participants
-8.2  (15.4) -9.0  (17.0)
Year 1 Number Analyzed 46 participants 45 participants
-9.5  (14.8) -10.5  (18.4)
Year 2 Number Analyzed 49 participants 45 participants
-9.7  (15.7) -14.1  (20.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tadalafil, Placebo
Comments Week 30
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.97
Comments [Not Specified]
Method t-test, 2 sided
Comments Significance level = 0.05
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tadalafil, Placebo
Comments Year 1
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.99
Comments [Not Specified]
Method t-test, 2 sided
Comments Significance level = 0.05
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Tadalafil, Placebo
Comments Year 2
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.24
Comments [Not Specified]
Method t-test, 2 sided
Comments Significance level = 0.05
4.Secondary Outcome
Title Overall Patient Sexual Satisfaction as Measured by Change From Baseline in the Sexual Adjustment Questionnaire (SAQ) Score
Hide Description The Sexual Adjustment Questionnaire (SAQ) is a 20-item questionnaire with an overall score range between 8 and 100 including the following domains: desire, ranging between 5 and 30; dysfunction, 0 and 25; activity, 0 and 10; satisfaction, 1 and 10; and fatigue, 1 and 5. The change in SAQ score is calculated by subtracting the baseline score from the follow-up score. A positive change indicates an improvement in sexual well-being.
Time Frame Baseline, week 30 and years 1 and 2 after the start of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients with data at baseline and corresponding time point
Arm/Group Title Tadalafil Placebo
Hide Arm/Group Description:
Beginning ≤ 7 days after the start of radiotherapy, patients receive oral tadalafil once daily for 24 weeks.
Beginning ≤ 7 days after the start of radiotherapy, patients receive oral placebo once daily for 24 weeks.
Overall Number of Participants Analyzed 63 51
Mean (Standard Deviation)
Unit of Measure: change in SAQ score
Week 30 Number Analyzed 47 participants 35 participants
-2.0  (11.3) -2.9  (8.0)
Year 1 Number Analyzed 36 participants 24 participants
-3.7  (9.7) -4.9  (9.9)
Year 2 Number Analyzed 31 participants 28 participants
-3.4  (9.3) -4.6  (14.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tadalafil, Placebo
Comments Week 30
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.70
Comments [Not Specified]
Method t-test, 2 sided
Comments Significance level = 0.05
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tadalafil, Placebo
Comments Year 1
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.65
Comments [Not Specified]
Method t-test, 2 sided
Comments Significance level = 0.05
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Tadalafil, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.72
Comments [Not Specified]
Method t-test, 2 sided
Comments Significance level = 0.05
5.Secondary Outcome
Title Overall Partner Sexual Satisfaction as Measured by Change From Baseline in the Sexual Adjustment Questionnaire-Partner (SAQ-P) Score
Hide Description The SAQ-P is an 18-item questionnaire with an overall score range between 0 and 90 including the following domains: desire, dysfunction, activity, satisfaction, and fatigue. The change in SAQ score is calculated by subtracting the baseline score from the follow-up score. A positive change indicates an improvement in sexual well-being.
Time Frame Baseline, week 30 and years 1 and 2 after the start of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Consenting partners of randomized eligible patients with data at baseline and corresponding time point
Arm/Group Title Tadalafil Placebo
Hide Arm/Group Description:
Beginning ≤ 7 days after the start of radiotherapy, patients receive oral tadalafil once daily for 24 weeks.
Beginning ≤ 7 days after the start of radiotherapy, patients receive oral placebo once daily for 24 weeks.
Overall Number of Participants Analyzed 42 40
Mean (Standard Deviation)
Unit of Measure: change in SAQ score
Week 30 Number Analyzed 27 participants 20 participants
-4.9  (7.5) -1.8  (8.2)
Year 1 Number Analyzed 21 participants 20 participants
-3.9  (6.4) -2.5  (7.1)
Year 2 Number Analyzed 18 participants 16 participants
1.5  (5.5) 5.1  (9.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tadalafil, Placebo
Comments Week 30
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.14
Comments [Not Specified]
Method t-test, 2 sided
Comments Significance level = 0.05
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tadalafil, Placebo
Comments Year 1
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.64
Comments [Not Specified]
Method t-test, 2 sided
Comments Significance level = 0.05
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Tadalafil, Placebo
Comments Year 2
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.18
Comments [Not Specified]
Method t-test, 2 sided
Comments Significance level = 0.05
6.Secondary Outcome
Title Patient Marital Adjustment as Measured by the Locke's Marital Adjustment Test
Hide Description The Locke Marital Adjustment Test (LMAT) is a 16-item questionnaire with scores ranging from 48 to 138 for participants. Higher scores indicate greater sexual function, sexual wellbeing, or marital adjustment. The change in LMAT score is calculated by subtracting the baseline score from the follow-up score.
Time Frame Baseline, week 30 and years 1 and 2 after the start of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients with data at baseline and time point of interest.
Arm/Group Title Tadalafil Placebo
Hide Arm/Group Description:
Beginning ≤ 7 days after the start of radiotherapy, patients receive oral tadalafil 5mg once daily for 24 weeks.
Beginning ≤ 7 days after the start of radiotherapy, patients receive oral placebo once daily for 24 weeks.
Overall Number of Participants Analyzed 61 60
Mean (Standard Deviation)
Unit of Measure: change in LMAT score
Week 30 Number Analyzed 35 participants 29 participants
-3.5  (7.7) -2.6  (10.4)
Year 1 Number Analyzed 22 participants 23 participants
-1.9  (7.2) -1.9  (6.3)
Year 2 Number Analyzed 27 participants 27 participants
-1.3  (9.87) -1.4  (5.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tadalafil, Placebo
Comments Week 30
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.67
Comments [Not Specified]
Method t-test, 2 sided
Comments Significance level = 0.05
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tadalafil, Placebo
Comments Year 1
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.98
Comments [Not Specified]
Method t-test, 2 sided
Comments Significance level = 0.05
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Tadalafil, Placebo
Comments Year 2
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.96
Comments [Not Specified]
Method t-test, 2 sided
Comments Significance level = 0.05
7.Secondary Outcome
Title Partner Marital Adjustment as Measured by the Locke's Marital Adjustment Test
Hide Description The Locke Marital Adjustment Test (LMAT) is a 16-item questionnaire with scores ranging from 48 to 138 for participants. Higher scores indicate greater sexual function, sexual wellbeing, or marital adjustment. The change in LMAT score is calculated by subtracting the baseline score from the follow-up score.
Time Frame Baseline, week 30 and years 1 and 2 after the start of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Consenting spouses of randomized, eligible patients with data at baseline and time point of interest
Arm/Group Title Tadalafil Placebo
Hide Arm/Group Description:
Beginning ≤ 7 days after the start of radiotherapy, patients receive oral tadalafil once daily for 24 weeks.
Beginning ≤ 7 days after the start of radiotherapy, patients receive oral placebo once daily for 24 weeks.
Overall Number of Participants Analyzed 34 27
Mean (Standard Error)
Unit of Measure: change in LMAT score
Week 30 Number Analyzed 19 participants 12 participants
-1.5  (6.3) -2.6  (6.4)
Year 1 Number Analyzed 16 participants 12 participants
-2.3  (5.1) 1.2  (7.3)
Year 2 Number Analyzed 13 participants 9 participants
-2.8  (5.8) -4.7  (7.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tadalafil, Placebo
Comments Week 30
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.86
Comments [Not Specified]
Method t-test, 2 sided
Comments Significance level = 0.05
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tadalafil, Placebo
Comments Year 1
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.93
Comments [Not Specified]
Method t-test, 2 sided
Comments Significance level = 0.05
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Tadalafil, Placebo
Comments Year 2
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.52
Comments [Not Specified]
Method t-test, 2 sided
Comments Significance level = 0.05
8.Other Pre-specified Outcome
Title Radiotherapy Factors Associated With Spontaneous (Off-drug) EF at Weeks 28-30 and Years 1 and 2 After Initiation of RT
Hide Description [Not Specified]
Time Frame Baseline, week 30 and years 1 and 2 after the start of treatment
Outcome Measure Data Not Reported
9.Other Pre-specified Outcome
Title Patient Follow-up Treatment for Erectile Dysfunction at Weeks 28-30 and Years 1 and 2 After Initiation of RT
Hide Description [Not Specified]
Time Frame Baseline, week 30 and years 1 and 2 after the start of treatment
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description Adverse event (AE) data is reported for eligible patients with adverse event data. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.
 
Arm/Group Title Tadalafil Placebo
Hide Arm/Group Description Beginning ≤ 7 days after the start of radiotherapy, patients receive oral tadalafil 5mg once daily for 24 weeks. Beginning ≤ 7 days after the start of radiotherapy, patients receive oral placebo once daily for 24 weeks.
All-Cause Mortality
Tadalafil Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Tadalafil Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   3/111 (2.70%)   4/108 (3.70%) 
Gastrointestinal disorders     
Abdominal pain * 1  1/111 (0.90%)  1/108 (0.93%) 
Gastritis * 1  1/111 (0.90%)  0/108 (0.00%) 
Nausea * 1  1/111 (0.90%)  0/108 (0.00%) 
Rectal hemorrhage * 1  0/111 (0.00%)  1/108 (0.93%) 
Vomiting * 1  1/111 (0.90%)  0/108 (0.00%) 
General disorders     
Chills * 1  1/111 (0.90%)  0/108 (0.00%) 
Infections and infestations     
Sepsis * 1  1/111 (0.90%)  0/108 (0.00%) 
Investigations     
Investigations - Other * 1  1/111 (0.90%)  0/108 (0.00%) 
Lymphocyte count decreased * 1  1/111 (0.90%)  0/108 (0.00%) 
Platelet count decreased * 1  1/111 (0.90%)  0/108 (0.00%) 
Weight loss * 1  1/111 (0.90%)  0/108 (0.00%) 
Metabolism and nutrition disorders     
Dehydration * 1  1/111 (0.90%)  0/108 (0.00%) 
Hyperglycemia * 1  1/111 (0.90%)  0/108 (0.00%) 
Hyponatremia * 1  1/111 (0.90%)  0/108 (0.00%) 
Nervous system disorders     
Presyncope * 1  0/111 (0.00%)  1/108 (0.93%) 
Renal and urinary disorders     
Urinary retention * 1  1/111 (0.90%)  0/108 (0.00%) 
Vascular disorders     
Hypotension * 1  1/111 (0.90%)  1/108 (0.93%) 
Thromboembolic event * 1  0/111 (0.00%)  1/108 (0.93%) 
Visceral arterial ischemia * 1  0/111 (0.00%)  1/108 (0.93%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (4.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Tadalafil Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   85/111 (76.58%)   76/108 (70.37%) 
Gastrointestinal disorders     
Diarrhea * 1  18/111 (16.22%)  10/108 (9.26%) 
Gastrointestinal disorders - Other * 1  7/111 (6.31%)  2/108 (1.85%) 
General disorders     
Fatigue * 1  30/111 (27.03%)  28/108 (25.93%) 
Musculoskeletal and connective tissue disorders     
Back pain * 1  6/111 (5.41%)  4/108 (3.70%) 
Nervous system disorders     
Headache * 1  9/111 (8.11%)  4/108 (3.70%) 
Renal and urinary disorders     
Cystitis noninfective * 1  7/111 (6.31%)  10/108 (9.26%) 
Renal and urinary disorders - Other * 1  22/111 (19.82%)  21/108 (19.44%) 
Urinary frequency * 1  55/111 (49.55%)  50/108 (46.30%) 
Urinary retention * 1  17/111 (15.32%)  19/108 (17.59%) 
Urinary tract pain * 1  15/111 (13.51%)  14/108 (12.96%) 
Urinary urgency * 1  36/111 (32.43%)  22/108 (20.37%) 
Reproductive system and breast disorders     
Ejaculation disorder * 1  7/111 (6.31%)  6/108 (5.56%) 
Erectile dysfunction * 1  34/111 (30.63%)  31/108 (28.70%) 
Reproductive system and breast disorders - Other * 1  6/111 (5.41%)  0/108 (0.00%) 
Vascular disorders     
Hypertension * 1  6/111 (5.41%)  2/108 (1.85%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (4.0)
The protocol endpoint "Patient-related predictors of erectile function" refers to modeling of the first two outcome measures, and is therefore reported as additional statistical analyses for those outcome measures.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
PI's are required to abide by the sponsor's publication guidelines which require review by coauthors and subsequent review and approval by the sponsor.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Wendy Seiferheld
Organization: NRG Onoclogy
EMail: seiferheldw@nrg.oncology.org
Layout table for additonal information
Responsible Party: Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier: NCT00931528     History of Changes
Other Study ID Numbers: RTOG 0831
CDR0000647146
NCI-2011-01934 ( Registry Identifier: CTRP (Clinical Trials Reporting Program) )
First Submitted: June 30, 2009
First Posted: July 2, 2009
Results First Submitted: April 18, 2016
Results First Posted: July 27, 2016
Last Update Posted: February 14, 2018