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

This study has been completed.
Sponsor:
Collaborators:
National Cancer Institute (NCI)
NRG Oncology
Information provided by (Responsible Party):
Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier:
NCT00931528
First received: June 30, 2009
Last updated: June 14, 2016
Last verified: June 2016
Results First Received: April 18, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Supportive Care
Conditions: Prostate Cancer
Sexual Dysfunction
Interventions: Drug: Tadalafil
Other: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Tadalafil Beginning ≤ 7 days after the start of radiotherapy, patients receive oral tadalafil 5mg once daily for 24 weeks.
Placebo Beginning ≤ 7 days after the start of radiotherapy, patients receive oral placebo once daily for 24 weeks.

Participant Flow:   Overall Study
    Tadalafil     Placebo  
STARTED     121     121  
COMPLETED     80 [1]   61 [1]
NOT COMPLETED     41     60  
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.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All randomized eligible patients.

Reporting Groups
  Description
Tadalafil Beginning ≤ 7 days after the start of radiotherapy, patients receive oral tadalafil 5mg once daily for 24 weeks.
Placebo Beginning ≤ 7 days after the start of radiotherapy, patients receive oral placebo once daily for 24 weeks.
Total Total of all reporting groups

Baseline Measures
    Tadalafil     Placebo     Total  
Number of Participants  
[units: participants]
  112     109     221  
Age  
[units: years]
Median (Full Range)
  63  
  (45 to 80)  
  63  
  (48 to 79)  
  63  
  (45 to 80)  
Gender  
[units: participants]
     
Female     0     0     0  
Male     112     109     221  



  Outcome Measures

1.  Primary:   Spontaneous (Off-drug) Erectile Function (EF) as Measured by International Index of Erectile Function (IIEF) at Weeks 28-30 After Initiation of Radiation Therapy (RT)   [ Time Frame: Baseline to 30 weeks from the start of radiation therapy ]

2.  Secondary:   Spontaneous (Off-drug) EF at Years 1 and 2 After Initiation of RT   [ Time Frame: Baseline to 2 years from the start of radiation therapy ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Overall Sexual Function as Measured by the IIEF at Weeks 28-30 and Years 1 and 2 After Initiation of RT   [ Time Frame: Baseline to 2 years from the start of radiation therapy ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Patient and Partner Overall Sexual Satisfaction as Measured by the Sexual Adjustment Questionnaire (SAQ) at Weeks 28-30 and Years 1 and 2 After Initiation of RT   [ Time Frame: Baseline to 2 years from the start of radiation therapy ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   Patient and Partner Marital Adjustment as Measured by the Locke's Marital Adjustment Test at Weeks 28-30 and Years 1 and 2 After Initiation of RT   [ Time Frame: Baseline to 2 years from the start of radiation therapy ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

6.  Secondary:   Patient-related Predictors of EF at Weeks 28-30 and Years 1 and 2 After Initiation of RT   [ Time Frame: Baseline to 2 years from the start of radiation therapy ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

7.  Secondary:   Patient Follow-up Treatment for Erectile Dysfunction at Weeks 28-30 and Years 1 and 2 After Initiation of RT   [ Time Frame: Baseline to 2 years from the start of radiation therapy ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

8.  Secondary:   Radiotherapy Factors Associated With Spontaneous (Off-drug) EF at Weeks 28-30 and Years 1 and 2 After Initiation of RT   [ Time Frame: Baseline to 2 years from the start of radiation therapy ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Wendy Seiferheld
Organization: NRG Onoclogy
e-mail: seiferheldw@nrg.oncology.org


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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) )
Study First Received: June 30, 2009
Results First Received: April 18, 2016
Last Updated: June 14, 2016
Health Authority: United States: Food and Drug Administration