Trial Outcomes & Findings for Study of Sildenafil Citrate During and After Radiotherapy/Hormone Therapy for Erectile Function Versus Radiotherapy/Hormone Therapy for Prostate Cancer (NCT NCT00142506)
NCT ID: NCT00142506
Last Updated: 2017-10-20
Results Overview
The International Index of Erectile Function (IIEF) is used for the evaluation of male sexual function and diagnostic evaluation of Erectile Dysfunction (ED) severity. There are 5 domains of the IIEF: erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction. A score of 0-5 is awarded to each question of the IIEF. Total IIEF scores range from 0-75. Lower scores indicate severe erectile dysfunction (0=severe erectile dysfunction), while higher scores indicate less erectile dysfunction (75=no erectile dysfunction).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
290 participants
Primary outcome timeframe
Baseline, 6 months, 12 months, 24 months
Results posted on
2017-10-20
Participant Flow
Participant milestones
| Measure |
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
|
|---|---|---|
|
Overall Study
STARTED
|
184
|
106
|
|
Overall Study
COMPLETED
|
112
|
77
|
|
Overall Study
NOT COMPLETED
|
72
|
29
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of Sildenafil Citrate During and After Radiotherapy/Hormone Therapy for Erectile Function Versus Radiotherapy/Hormone Therapy for Prostate Cancer
Baseline characteristics by cohort
| Measure |
Prophylactic Sildenafil Citrate With Radiotherapy
n=184 Participants
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
n=106 Participants
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
n=290 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
112 Participants
n=93 Participants
|
60 Participants
n=4 Participants
|
172 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
72 Participants
n=93 Participants
|
46 Participants
n=4 Participants
|
118 Participants
n=27 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
184 Participants
n=93 Participants
|
106 Participants
n=4 Participants
|
290 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
184 participants
n=93 Participants
|
106 participants
n=4 Participants
|
290 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline, 6 months, 12 months, 24 monthsThe International Index of Erectile Function (IIEF) is used for the evaluation of male sexual function and diagnostic evaluation of Erectile Dysfunction (ED) severity. There are 5 domains of the IIEF: erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction. A score of 0-5 is awarded to each question of the IIEF. Total IIEF scores range from 0-75. Lower scores indicate severe erectile dysfunction (0=severe erectile dysfunction), while higher scores indicate less erectile dysfunction (75=no erectile dysfunction).
Outcome measures
| Measure |
Prophylactic Sildenafil Citrate With Radiotherapy
n=125 Participants
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
n=77 Participants
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
|
|---|---|---|
|
Assessment of Erectile Dysfunction
Baseline
|
64 units on a scale
Interval 57.0 to 71.0
|
64 units on a scale
Interval 56.75 to 69.0
|
|
Assessment of Erectile Dysfunction
6 mos
|
59.00 units on a scale
Interval 41.5 to 67.75
|
58 units on a scale
Interval 35.0 to 64.0
|
|
Assessment of Erectile Dysfunction
12 mos
|
58.00 units on a scale
Interval 41.5 to 66.75
|
51 units on a scale
Interval 34.5 to 63.5
|
|
Assessment of Erectile Dysfunction
24 months (2 years)
|
58 units on a scale
Interval 39.0 to 65.0
|
54.50 units on a scale
Interval 29.75 to 64.75
|
Adverse Events
Prophylactic Sildenafil Citrate With Radiotherapy
Serious events: 38 serious events
Other events: 4 other events
Deaths: 0 deaths
Placebo With Radiotherapy
Serious events: 15 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Prophylactic Sildenafil Citrate With Radiotherapy
n=184 participants at risk
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
n=106 participants at risk
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
|
|---|---|---|
|
Metabolism and nutrition disorders
ALT, SGPT
|
4.3%
8/184 • Number of events 13 • 24 months
|
3.8%
4/106 • Number of events 7 • 24 months
|
|
Metabolism and nutrition disorders
AST, SGOT
|
2.7%
5/184 • Number of events 11 • 24 months
|
3.8%
4/106 • Number of events 7 • 24 months
|
|
Metabolism and nutrition disorders
Albumin, low (hypoalbuminemia)
|
2.7%
5/184 • Number of events 22 • 24 months
|
0.94%
1/106 • Number of events 1 • 24 months
|
|
Metabolism and nutrition disorders
Alkaline phosphatase
|
1.1%
2/184 • Number of events 5 • 24 months
|
1.9%
2/106 • Number of events 2 • 24 months
|
|
Metabolism and nutrition disorders
Bilirubin (hyperbilirubinemia)
|
1.6%
3/184 • Number of events 5 • 24 months
|
0.00%
0/106 • 24 months
|
|
Metabolism and nutrition disorders
Calcium, high (hypercalcemia)
|
0.54%
1/184 • Number of events 1 • 24 months
|
0.00%
0/106 • 24 months
|
|
Metabolism and nutrition disorders
Creatinine
|
6.5%
12/184 • Number of events 24 • 24 months
|
3.8%
4/106 • Number of events 4 • 24 months
|
|
Metabolism and nutrition disorders
Glucose, high (hyperglycemia)
|
14.1%
26/184 • Number of events 80 • 24 months
|
5.7%
6/106 • Number of events 7 • 24 months
|
|
Blood and lymphatic system disorders
Hemoglobin
|
4.9%
9/184 • Number of events 45 • 24 months
|
2.8%
3/106 • Number of events 3 • 24 months
|
|
Blood and lymphatic system disorders
INR
|
1.1%
2/184 • Number of events 9 • 24 months
|
0.00%
0/106 • 24 months
|
|
Blood and lymphatic system disorders
Leukocytes (total WBC)
|
2.7%
5/184 • Number of events 12 • 24 months
|
0.00%
0/106 • 24 months
|
|
Blood and lymphatic system disorders
Lymphopenia
|
1.6%
3/184 • Number of events 5 • 24 months
|
0.00%
0/106 • 24 months
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes (ANC/AGC)
|
0.54%
1/184 • Number of events 1 • 24 months
|
0.00%
0/106 • 24 months
|
|
Blood and lymphatic system disorders
PTT
|
0.54%
1/184 • Number of events 1 • 24 months
|
0.00%
0/106 • 24 months
|
|
Metabolism and nutrition disorders
Phosphate, low (hypophosphatemia)
|
1.1%
2/184 • Number of events 4 • 24 months
|
0.00%
0/106 • 24 months
|
|
Blood and lymphatic system disorders
Platelets
|
3.3%
6/184 • Number of events 10 • 24 months
|
1.9%
2/106 • Number of events 2 • 24 months
|
|
Metabolism and nutrition disorders
Potassium, high (hyperkalemia)
|
1.6%
3/184 • Number of events 4 • 24 months
|
0.94%
1/106 • Number of events 1 • 24 months
|
|
Metabolism and nutrition disorders
Sodium, high (hypernatremia)
|
1.6%
3/184 • Number of events 4 • 24 months
|
0.94%
1/106 • Number of events 1 • 24 months
|
|
Metabolism and nutrition disorders
Sodium, low (hyponatremia)
|
1.6%
3/184 • Number of events 12 • 24 months
|
0.94%
1/106 • Number of events 1 • 24 months
|
|
Metabolism and nutrition disorders
Trglycrde, high (hypertriglyceridemia)
|
0.54%
1/184 • Number of events 2 • 24 months
|
0.00%
0/106 • 24 months
|
|
Metabolism and nutrition disorders
Cholesterol,high(hypercholestremia)
|
0.00%
0/184 • 24 months
|
0.94%
1/106 • Number of events 1 • 24 months
|
|
Metabolism and nutrition disorders
Glucose, low (hypoglycemia)
|
0.00%
0/184 • 24 months
|
1.9%
2/106 • Number of events 2 • 24 months
|
Other adverse events
| Measure |
Prophylactic Sildenafil Citrate With Radiotherapy
n=184 participants at risk
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
n=106 participants at risk
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
|
|---|---|---|
|
Metabolism and nutrition disorders
Glucose, high (hyperglycemia)
|
2.2%
4/184 • Number of events 11 • 24 months
|
0.94%
1/106 • Number of events 2 • 24 months
|
Additional Information
MICHAEL J ZELEFSKY
MEMORIAL SLOAN KETTERING CANCER CENTER
Phone: +1212-639-6802
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place