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Study of Sildenafil Citrate During and After Radiotherapy/Hormone Therapy for Erectile Function Versus Radiotherapy/Hormone Therapy for Prostate Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00142506
First Posted: September 2, 2005
Last Update Posted: October 20, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Icahn School of Medicine at Mount Sinai
Beth Israel Medical Center
St. Luke's-Roosevelt Hospital Center
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center
Results First Submitted: December 17, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Prevention
Conditions: Prostate Cancer
Erectile Dysfunction
Interventions: Drug: sildenafil citrate and questionaires
Drug: placebo tablets and questionaires

  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
Prophylactic Sildenafil Citrate With Radiotherapy

radiotherapy with hormones, questionaire assessments

sildenafil citrate and questionaires: Hormone therapy patients will be instructed to begin the study drug simultaneously or within 1 month of start of hormone therapy. These patients will then continue to take the study drug for approximately 6 months following start of radiotherapy.In addition, during prophylactic phase (drug and placebo prophylactic arms) patients will have the opportunity to utilize oral 50 mg. tablets of Sildenafil Citrate in an on demand open label, flexible dose fashion. Hormone patients will be offered on demand Sildenafil for approximately 15-21 months.

Hormone therapy patients will complete assessments at baseline (within 4 weeks of start of study treatment) each month (only IIEF and QOL) before start of radiotherapy, at start of radiotherapy and at months 3, 6, 9, 12 18 and 24 from start of radiotherapy. Testosterone assessments will take place at baseline, and months 12 and 24.

Placebo With Radiotherapy

radiotherapy without hormones, questionaire assessments

placebo tablets & questionaires: Non-hormone therapy patients will be instructed to begin the study drug 3 days prior to start of radiotherapy. Patients beginning study drug anytime between 3 days before start of radiotherapy and 2 weeks after the first day of radiotherapy will also be acceptable. These patients will then continue to take the study drug for approximately 6 months following start of radiotherapy.

In addition, during prophylactic phase (drug and placebo prophylactic arms) patients will have the opportunity to utilize oral 50 mg. tablets of Sildenafil Citrate in an on demand, open label, flexible dose fashion. Non-hormone patients will be offered on demand Sildenafil for approximately 12 months.

Assessments (IIEF, IPSS, QOL) will be completed by non-hormone therapy patients at baseline (within 4 weeks of start of study treatment) and at approximately months 3, 6, 9, 12, 18 and 24 from start of radiotherap


Participant Flow:   Overall Study
    Prophylactic Sildenafil Citrate With Radiotherapy   Placebo With Radiotherapy
STARTED   184   106 
COMPLETED   112   77 
NOT COMPLETED   72   29 



  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.
No text entered.

Reporting Groups
  Description
Prophylactic Sildenafil Citrate With Radiotherapy

radiotherapy with hormones, questionaire assessments

sildenafil citrate and questionaires: Hormone therapy patients will be instructed to begin the study drug simultaneously or within 1 month of start of hormone therapy. These patients will then continue to take the study drug for approximately 6 months following start of radiotherapy.In addition, during prophylactic phase (drug and placebo prophylactic arms) patients will have the opportunity to utilize oral 50 mg. tablets of Sildenafil Citrate in an on demand open label, flexible dose fashion. Hormone patients will be offered on demand Sildenafil for approximately 15-21 months.

Hormone therapy patients will complete assessments at baseline (within 4 weeks of start of study treatment) each month (only IIEF and QOL) before start of radiotherapy, at start of radiotherapy and at months 3, 6, 9, 12 18 and 24 from start of radiotherapy. Testosterone assessments will take place at baseline, and months 12 and 24.

Placebo With Radiotherapy

radiotherapy without hormones, questionaire assessments

placebo tablets & questionaires: Non-hormone therapy patients will be instructed to begin the study drug 3 days prior to start of radiotherapy. Patients beginning study drug anytime between 3 days before start of radiotherapy and 2 weeks after the first day of radiotherapy will also be acceptable. These patients will then continue to take the study drug for approximately 6 months following start of radiotherapy.

In addition, during prophylactic phase (drug and placebo prophylactic arms) patients will have the opportunity to utilize oral 50 mg. tablets of Sildenafil Citrate in an on demand, open label, flexible dose fashion. Non-hormone patients will be offered on demand Sildenafil for approximately 12 months.

Assessments (IIEF, IPSS, QOL) will be completed by non-hormone therapy patients at baseline (within 4 weeks of start of study treatment) and at approximately months 3, 6, 9, 12, 18 and 24 from start of radiotherap

Total Total of all reporting groups

Baseline Measures
   Prophylactic Sildenafil Citrate With Radiotherapy   Placebo With Radiotherapy   Total 
Overall Participants Analyzed 
[Units: Participants]
 184   106   290 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      112  60.9%      60  56.6%      172  59.3% 
>=65 years      72  39.1%      46  43.4%      118  40.7% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      0   0.0%      0   0.0%      0   0.0% 
Male      184 100.0%      106 100.0%      290 100.0% 
Region of Enrollment 
[Units: Participants]
     
United States   184   106   290 


  Outcome Measures

1.  Primary:   Assessment of Erectile Dysfunction   [ Time Frame: Baseline, 6 months, 12 months, 24 months ]


  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
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: MICHAEL J ZELEFSKY
Organization: MEMORIAL SLOAN KETTERING CANCER CENTER
phone: +1212-639-6802
e-mail: zelefskm@MSKCC.ORG



Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00142506     History of Changes
Other Study ID Numbers: 05-007
First Submitted: August 31, 2005
First Posted: September 2, 2005
Results First Submitted: December 17, 2015
Results First Posted: October 20, 2017
Last Update Posted: October 20, 2017