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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2009-01602 | Registry Identifier | NCI CTRP | |
| CDR0000570272 | Registry Identifier | PDQ |
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Accrual too slow
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RATIONALE: Sildenafil citrate and alprostadil may help patients who have undergone prostatectomy for prostate cancer to recover from erectile dysfunction.
PURPOSE: This randomized clinical trial is studying giving sildenafil together with alprostadil in treating patients undergoing nerve-sparing robotic-assisted radical prostatectomy for nonmetastatic prostate cancer.
PRIMARY OBJECTIVES:
I. To determine the rate of erectile function (defined as the ability to achieve and maintain an erection sufficient for intercourse without the use of pharmacological assistance) at 1 year post-operatively in men undergoing BNS-RAP without the use of post-operative maintenance pharmacotherapy.
II. To describe whether early post-operative maintenance pharmacotherapy Viagra can improve return of erectile function at 1 year post-operatively in patients undergoing BNS-RAP.
III. To describe if early post-operative maintenance pharmacotherapy Viagra can decrease the time-to-return of erectile function in patients undergoing BNS-RAP.
SECONDARY OBJECTIVES:
I. To describe whether early post-operative maintenance pharmacotherapy MUSE can improve return of erectile function at 1 year post-operatively in patients undergoing BNS-RAP.
II. To describe if early post-operative maintenance pharmacotherapy MUSE can decrease the time-to-return of erectile function in patients undergoing BNS-RAP.
III. To compare sexual function quality of life in men undergoing early post-operative maintenance pharmacotherapy to those without early post-operative maintenance pharmacotherapy.
IV. To compare the rate of potency at 1, 3, 6, 9, 12, and 18 months in men using Viagra versus MUSE for early post-operative maintenance pharmacotherapy.
V. To describe the dropout rate for MUSE maintenance pharmacotherapy secondary to urethral pain in men using 2% Lidocaine lubricant.
VI. To describe if penile length is decreased following BNS-RAP. VII. To describe if penile length at one year is different in men who have return of potency versus those with no return of potency.
OUTLINE: Patients receive 2 doses of intraurethral alprostadil prior to undergoing bilateral nerve-sparing robotic-assisted prostatectomy. Within 4 weeks after surgery, patients are randomized to 1 of 3 treatment arms.
ARM I: Patients receive intraurethral alprostadil once daily for up to 9 months in the absence of disease progression or unacceptable toxicity. Patients also receive 3 doses of oral sildenafil citrate at least 48 hours apart monthly for up to 18 months.
ARM II: Patients receive 3 doses of oral sildenafil citrate on 3 separate occasions at least 48 hours apart monthly for 18 months.
ARM III: Patients receive oral sildenafil citrate once daily for up to 9 months in the absence of disease progression or unacceptable toxicity. Patients also receive 3 doses of oral sildenafil citrate at least 48 hours apart monthly for up to 18 months.
After completion of study treatment, patients are followed periodically for up to 18 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sildenafil Citrate/Mo+Aprostadil/day | Experimental | Patients receive intraurethral alprostadil once daily for up to 9 months in the absence of disease progression or unacceptable toxicity. Patients also receive 3 doses of oral sildenafil citrate at least 48 hours apart monthly for up to 18 months. Patients on all three arms will have undergone robotic-assisted laparoscopic surgery. All patients will take part in the questionnaire administration and quality-of-life assessments. |
|
| Sildenafil Citrate Monthly | Active Comparator | Patients receive 3 doses of oral sildenafil citrate on 3 separate occasions at least 48 hours apart monthly for 18 months. Patients on all three arms will have undergone robotic-assisted laparoscopic surgery. All patients will take part in the questionnaire administration and quality-of-life assessments. |
|
| Daily Sildenafil Citrate | Experimental | Patients receive oral sildenafil citrate once daily for up to 9 months in the absence of disease progression or unacceptable toxicity. Patients also receive 3 doses of oral sildenafil citrate at least 48 hours apart monthly for up to 18 months. Patients on all three arms will have undergone robotic-assisted laparoscopic surgery. All patients will take part in the questionnaire administration and quality-of-life assessments. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sildenafil citrate | Drug | Given orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Potency Rates (Ability to Obtain an Erection Sufficient for Penetration) Without Assistance Compared Between Patients in All Three Arms of the Study at 12 Months | Potency rates (ability to obtain an erection sufficient for penetration) without assistance in those patients receiving maintenance Viagra compared to non-pharmacology controls was compared at 12 months from start of treatment using the fisher's exact test | 12 months following BNS-RAP |
| Measure | Description | Time Frame |
|---|---|---|
| Potency Rates With or Without Assistance in the Control Group Versus Maintenance MUSE or Maintenance Viagra | Potency rates with or without assistance in the control group versus maintenance MUSE or maintenance Viagra were compared at each of 6 and 18 months | At 6 and 18 months |
| SHIMS-5 Scores in the Control Groups Versus Maintenance MUSE or Maintenance Viagra Groups |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Laura Crocitto | City of Hope Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope | Duarte | California | 91010 | United States |
Not provided
10 patients were not randomized, for the following reasons:
(5) deemed to have sensitivity to MUSE -- 2 patients
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| ID | Title | Description |
|---|---|---|
| FG000 | Sildenafil Citrate/Mo+Aprostadil/Day | Patients receive intraurethral alprostadil once daily for up to 9 months in the absence of disease progression or unacceptable toxicity. Patients also receive 3 doses of oral sildenafil citrate at least 48 hours apart monthly for up to 18 months. Patients on all three arms will have undergone robotic-assisted laparoscopic surgery. All patients will take part in the questionnaire administration and quality-of-life assessments. sildenafil citrate: Given orally alprostadil: Given intraurethrally robotic-assisted laparoscopic surgery: Undergo prostatectomy quality-of-life assessment: Ancillary studies questionnaire administration: Ancillary studies |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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| alprostadil | Drug | Given intraurethrally |
|
|
| robotic-assisted laparoscopic surgery | Procedure | Undergo prostatectomy |
|
| quality-of-life assessment | Procedure | Ancillary studies |
|
|
| questionnaire administration | Other | Ancillary studies |
|
Median and range of SHIM scores evaluated at 1, 3, 6, 9, 12, and 18 months. SHIMS-5 is the Sexual Health Inventory for Men, which includes 5 questions that are scored from 1 to 5 each. The total score is obtained by adding all five response scores, and can range from 5 to 25 when all 5 questions are answered. Questions that are left unanswered are scored as a 0, and can result in an overall score lower than 5 (as low as 0). Higher scores are more desirable. A Score of 22-25 = no ED, 17-21=Mild ED, 12-16=Mild to moderate ED, 8-11=Moderate ED, and 5-7 =Severe ED (ED=Erectile Dysfunction). There are no sub-scale scores within this questionnaire. |
| At 1, 3, 6, 9, 12, and 18 months |
| Penile Length | measurement of penile length in centimeters | At pre-treatment and 18 months |
| FG001 | Sildenafil Citrate Monthly | Patients receive 3 doses of oral sildenafil citrate on 3 separate occasions at least 48 hours apart monthly for 18 months. Patients on all three arms will have undergone robotic-assisted laparoscopic surgery. All patients will take part in the questionnaire administration and quality-of-life assessments. sildenafil citrate: Given orally robotic-assisted laparoscopic surgery: Undergo prostatectomy quality-of-life assessment: Ancillary studies questionnaire administration: Ancillary studies |
| FG002 | Daily Sildenafil Citrate | P atients receive oral sildenafil citrate once daily for up to 9 months in the absence of disease progression or unacceptable toxicity. Patients also receive 3 doses of oral sildenafil citrate at least 48 hours apart monthly for up to 18 months. Patients on all three arms will have undergone robotic-assisted laparoscopic surgery. All patients will take part in the questionnaire administration and quality-of-life assessments. sildenafil citrate: Given orally robotic-assisted laparoscopic surgery: Undergo prostatectomy quality-of-life assessment: Ancillary studies questionnaire administration: Ancillary studies |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Sildenafil Citrate/Mo+Aprostadil/Day | Patients receive intraurethral alprostadil once daily for up to 9 months in the absence of disease progression or unacceptable toxicity. Patients also receive 3 doses of oral sildenafil citrate at least 48 hours apart monthly for up to 18 months. Patients on all three arms will have undergone robotic-assisted laparoscopic surgery. All patients will take part in the questionnaire administration and quality-of-life assessments. sildenafil citrate: Given orally alprostadil: Given intraurethrally robotic-assisted laparoscopic surgery: Undergo prostatectomy quality-of-life assessment: Ancillary studies questionnaire administration: Ancillary studies |
| BG001 | Sildenafil Citrate Monthly | Patients receive 3 doses of oral sildenafil citrate on 3 separate occasions at least 48 hours apart monthly for 18 months. Patients on all three arms will have undergone robotic-assisted laparoscopic surgery. All patients will take part in the questionnaire administration and quality-of-life assessments. sildenafil citrate: Given orally robotic-assisted laparoscopic surgery: Undergo prostatectomy quality-of-life assessment: Ancillary studies questionnaire administration: Ancillary studies |
| BG002 | Sildenafil Citrate Monthly Daily Sildenafil Citrate | Patients receive oral sildenafil citrate once daily for up to 9 months in the absence of disease progression or unacceptable toxicity. Patients also receive 3 doses of oral sildenafil citrate at least 48 hours apart monthly for up to 18 months. Patients on all three arms will have undergone robotic-assisted laparoscopic surgery. All patients will take part in the questionnaire administration and quality-of-life assessments. sildenafil citrate: Given orally robotic-assisted laparoscopic surgery: Undergo prostatectomy quality-of-life assessment: Ancillary studies questionnaire administration: Ancillary studies |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Inter-Quartile Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Potency Rates (Ability to Obtain an Erection Sufficient for Penetration) Without Assistance Compared Between Patients in All Three Arms of the Study at 12 Months | Potency rates (ability to obtain an erection sufficient for penetration) without assistance in those patients receiving maintenance Viagra compared to non-pharmacology controls was compared at 12 months from start of treatment using the fisher's exact test | These are the patients who remained on treatment for the duration of the 12 months and were evaluable at that time point. | Posted | Count of Participants | Participants | 12 months following BNS-RAP |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Potency Rates With or Without Assistance in the Control Group Versus Maintenance MUSE or Maintenance Viagra | Potency rates with or without assistance in the control group versus maintenance MUSE or maintenance Viagra were compared at each of 6 and 18 months | patients who were evaluated at 6 months, 18 months | Posted | Count of Participants | Participants | At 6 and 18 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | SHIMS-5 Scores in the Control Groups Versus Maintenance MUSE or Maintenance Viagra Groups | Median and range of SHIM scores evaluated at 1, 3, 6, 9, 12, and 18 months. SHIMS-5 is the Sexual Health Inventory for Men, which includes 5 questions that are scored from 1 to 5 each. The total score is obtained by adding all five response scores, and can range from 5 to 25 when all 5 questions are answered. Questions that are left unanswered are scored as a 0, and can result in an overall score lower than 5 (as low as 0). Higher scores are more desirable. A Score of 22-25 = no ED, 17-21=Mild ED, 12-16=Mild to moderate ED, 8-11=Moderate ED, and 5-7 =Severe ED (ED=Erectile Dysfunction). There are no sub-scale scores within this questionnaire. | patients with shim scores at 1 month | Posted | Median | Full Range | units on a scale | At 1, 3, 6, 9, 12, and 18 months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Penile Length | measurement of penile length in centimeters | patients who were willing to have penile measurements taken at baseline | Posted | Median | Full Range | centimeters | At pre-treatment and 18 months |
|
The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sildenafil Citrate/Mo+Aprostadil/Day | Patients receive intraurethral alprostadil once daily for up to 9 months in the absence of disease progression or unacceptable toxicity. Patients also receive 3 doses of oral sildenafil citrate at least 48 hours apart monthly for up to 18 months. Patients on all three arms will have undergone robotic-assisted laparoscopic surgery. All patients will take part in the questionnaire administration and quality-of-life assessments. sildenafil citrate: Given orally alprostadil: Given intraurethrally robotic-assisted laparoscopic surgery: Undergo prostatectomy quality-of-life assessment: Ancillary studies questionnaire administration: Ancillary studies | 0 | 34 | 0 | 34 | 24 | 34 |
| EG001 | Sildenafil Citrate Monthly | Patients receive 3 doses of oral sildenafil citrate on 3 separate occasions at least 48 hours apart monthly for 18 months. Patients on all three arms will have undergone robotic-assisted laparoscopic surgery. All patients will take part in the questionnaire administration and quality-of-life assessments. sildenafil citrate: Given orally robotic-assisted laparoscopic surgery: Undergo prostatectomy quality-of-life assessment: Ancillary studies questionnaire administration: Ancillary studies | 0 | 35 | 0 | 35 | 19 | 35 |
| EG002 | Daily Sildenafil Citrate | Patients receive oral sildenafil citrate once daily for up to 9 months in the absence of disease progression or unacceptable toxicity. Patients also receive 3 doses of oral sildenafil citrate at least 48 hours apart monthly for up to 18 months. Patients on all three arms will have undergone robotic-assisted laparoscopic surgery. All patients will take part in the questionnaire administration and quality-of-life assessments. sildenafil citrate: Given orally robotic-assisted laparoscopic surgery: Undergo prostatectomy quality-of-life assessment: Ancillary studies questionnaire administration: Ancillary studies | 0 | 31 | 0 | 31 | 24 | 31 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | MEDDRA10.0 | Non-systematic Assessment |
| |
| External ear inflammation | Ear and labyrinth disorders | MEDDRA10.0 | Non-systematic Assessment |
| |
| External ear pain | Ear and labyrinth disorders | MEDDRA10.0 | Non-systematic Assessment |
| |
| Cataract | Eye disorders | MEDDRA10.0 | Non-systematic Assessment |
| |
| Eye disorders - Other, specify | Eye disorders | MEDDRA10.0 | Non-systematic Assessment |
| |
| Eye pain | Eye disorders | MEDDRA10.0 | Non-systematic Assessment |
| |
| Photophobia | Eye disorders | MEDDRA10.0 | Non-systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MEDDRA10.0 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MEDDRA10.0 | Non-systematic Assessment |
| |
| Cheilitis | Gastrointestinal disorders | MEDDRA10.0 | Non-systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MEDDRA10.0 | Non-systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MEDDRA10.0 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MEDDRA10.0 | Non-systematic Assessment |
| |
| Fecal incontinence | Gastrointestinal disorders | MEDDRA10.0 | Non-systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MEDDRA10.0 | Non-systematic Assessment |
| |
| Gastrointestinal disorders - Other, specify | Gastrointestinal disorders | MEDDRA10.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MEDDRA10.0 | Non-systematic Assessment |
| |
| Rectal hemorrhage | Gastrointestinal disorders | MEDDRA10.0 | Non-systematic Assessment |
| |
| Stomach pain | Gastrointestinal disorders | MEDDRA10.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MEDDRA10.0 | Non-systematic Assessment |
| |
| Chills | General disorders | MEDDRA10.0 | Non-systematic Assessment |
| |
| Edema trunk | General disorders | MEDDRA10.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MEDDRA10.0 | Non-systematic Assessment |
| |
| General disorders and administration site conditions - Other, specify | General disorders | MEDDRA10.0 | Non-systematic Assessment |
| |
| Pain | General disorders | MEDDRA10.0 | Non-systematic Assessment |
| |
| Bladder infection | Infections and infestations | MEDDRA10.0 | Non-systematic Assessment |
| |
| Infections and infestations - Other, specify | Infections and infestations | MEDDRA10.0 | Non-systematic Assessment |
| |
| Bladder anastomotic leak | Injury, poisoning and procedural complications | MEDDRA10.0 | Non-systematic Assessment |
| |
| Bruising | Injury, poisoning and procedural complications | MEDDRA10.0 | Non-systematic Assessment |
| |
| Wound dehiscence | Injury, poisoning and procedural complications | MEDDRA10.0 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MEDDRA10.0 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MEDDRA10.0 | Non-systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MEDDRA10.0 | Non-systematic Assessment |
| |
| Cholesterol high | Investigations | MEDDRA10.0 | Non-systematic Assessment |
| |
| Creatinine increased | Investigations | MEDDRA10.0 | Non-systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MEDDRA10.0 | Non-systematic Assessment |
| |
| Alkalosis | Metabolism and nutrition disorders | MEDDRA10.0 | Non-systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | MEDDRA10.0 | Non-systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | MEDDRA10.0 | Non-systematic Assessment |
| |
| Hyperkalemia | Metabolism and nutrition disorders | MEDDRA10.0 | Non-systematic Assessment |
| |
| Hypertriglyceridemia | Metabolism and nutrition disorders | MEDDRA10.0 | Non-systematic Assessment |
| |
| Hyperuricemia | Metabolism and nutrition disorders | MEDDRA10.0 | Non-systematic Assessment |
| |
| Hypocalcemia | Metabolism and nutrition disorders | MEDDRA10.0 | Non-systematic Assessment |
| |
| Hypoglycemia | Metabolism and nutrition disorders | MEDDRA10.0 | Non-systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | MEDDRA10.0 | Non-systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | MEDDRA10.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MEDDRA10.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MEDDRA10.0 | Non-systematic Assessment |
| |
| Memory impairment | Nervous system disorders | MEDDRA10.0 | Non-systematic Assessment |
| |
| Nervous system disorders - Other, specify | Nervous system disorders | MEDDRA10.0 | Non-systematic Assessment |
| |
| Sinus pain | Nervous system disorders | MEDDRA10.0 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MEDDRA10.0 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MEDDRA10.0 | Non-systematic Assessment |
| |
| Libido decreased | Psychiatric disorders | MEDDRA10.0 | Non-systematic Assessment |
| |
| Hematuria | Renal and urinary disorders | MEDDRA10.0 | Non-systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MEDDRA10.0 | Non-systematic Assessment |
| |
| Renal and urinary disorders - Other, specify | Renal and urinary disorders | MEDDRA10.0 | Non-systematic Assessment |
| |
| Urinary frequency | Renal and urinary disorders | MEDDRA10.0 | Non-systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | MEDDRA10.0 | Non-systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MEDDRA10.0 | Non-systematic Assessment |
| |
| Urinary tract obstruction | Renal and urinary disorders | MEDDRA10.0 | Non-systematic Assessment |
| |
| Urinary tract pain | Renal and urinary disorders | MEDDRA10.0 | Non-systematic Assessment |
| |
| Urine discoloration | Renal and urinary disorders | MEDDRA10.0 | Non-systematic Assessment |
| |
| Erectile dysfunction | Reproductive system and breast disorders | MEDDRA10.0 | Non-systematic Assessment |
| |
| Pelvic pain | Reproductive system and breast disorders | MEDDRA10.0 | Non-systematic Assessment |
| |
| Penile pain | Reproductive system and breast disorders | MEDDRA10.0 | Non-systematic Assessment |
| |
| Reproductive system and breast disorders - Other, specify | Reproductive system and breast disorders | MEDDRA10.0 | Non-systematic Assessment |
| |
| Scrotal pain | Reproductive system and breast disorders | MEDDRA10.0 | Non-systematic Assessment |
| |
| Testicular pain | Reproductive system and breast disorders | MEDDRA10.0 | Non-systematic Assessment |
| |
| Allergic rhinitis | Respiratory, thoracic and mediastinal disorders | MEDDRA10.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MEDDRA10.0 | Non-systematic Assessment |
| |
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MEDDRA10.0 | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MEDDRA10.0 | Non-systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MEDDRA10.0 | Non-systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MEDDRA10.0 | Non-systematic Assessment |
| |
| Flushing | Vascular disorders | MEDDRA10.0 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MEDDRA10.0 | Non-systematic Assessment |
|
In addition to the fact that the trial was closed mid-way through accrual, nearly half of those that accrued dropped out prior to completing treatment. There is not enough power to make any conclusions regarding any of the aims set forth.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Laura Crocitto, M.D. | City of Hope | 626-218-3708 | lcrocitto@coh.org |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D007172 | Erectile Dysfunction |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D012735 | Sexual Dysfunction, Physiological |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068677 | Sildenafil Citrate |
| D000527 | Alprostadil |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D011458 | Prostaglandins E |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D005229 | Fatty Acids, Monounsaturated |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |
Not provided
Not provided
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| OG002 | Daily Sildenafil Citrate | P atients receive oral sildenafil citrate once daily for up to 9 months in the absence of disease progression or unacceptable toxicity. Patients also receive 3 doses of oral sildenafil citrate at least 48 hours apart monthly for up to 18 months. Patients on all three arms will have undergone robotic-assisted laparoscopic surgery. All patients will take part in the questionnaire administration and quality-of-life assessments. sildenafil citrate: Given orally robotic-assisted laparoscopic surgery: Undergo prostatectomy quality-of-life assessment: Ancillary studies questionnaire administration: Ancillary studies |
|
|
|
| Sildenafil Citrate Monthly |
Patients receive 3 doses of oral sildenafil citrate on 3 separate occasions at least 48 hours apart monthly for 18 months. Patients on all three arms will have undergone robotic-assisted laparoscopic surgery. All patients will take part in the questionnaire administration and quality-of-life assessments. sildenafil citrate: Given orally robotic-assisted laparoscopic surgery: Undergo prostatectomy quality-of-life assessment: Ancillary studies questionnaire administration: Ancillary studies |
| OG002 | Daily Sildenafil Citrate | P atients receive oral sildenafil citrate once daily for up to 9 months in the absence of disease progression or unacceptable toxicity. Patients also receive 3 doses of oral sildenafil citrate at least 48 hours apart monthly for up to 18 months. Patients on all three arms will have undergone robotic-assisted laparoscopic surgery. All patients will take part in the questionnaire administration and quality-of-life assessments. sildenafil citrate: Given orally robotic-assisted laparoscopic surgery: Undergo prostatectomy quality-of-life assessment: Ancillary studies questionnaire administration: Ancillary studies |
|
|
|
| OG002 | Daily Sildenafil Citrate | P atients receive oral sildenafil citrate once daily for up to 9 months in the absence of disease progression or unacceptable toxicity. Patients also receive 3 doses of oral sildenafil citrate at least 48 hours apart monthly for up to 18 months. Patients on all three arms will have undergone robotic-assisted laparoscopic surgery. All patients will take part in the questionnaire administration and quality-of-life assessments. sildenafil citrate: Given orally robotic-assisted laparoscopic surgery: Undergo prostatectomy quality-of-life assessment: Ancillary studies questionnaire administration: Ancillary studies |
|
|
|