|
|
Home
Search
Study Topics
Glossary
|
 |
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||||||||||||||||||||||
| Sponsor: | Memorial Sloan-Kettering Cancer Center |
|---|---|
| Collaborator: |
Pfizer |
| Information provided by: | Memorial Sloan-Kettering Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00955929 |
Purpose
When a bilateral nerve-sparing radical prostatectomy (RP) is performed, recovery of erectile function (rigid erections) is reported for up to 80% of patients, who are less than 60 years old. Erectile function recovery is also impacted by patient age, erectile function before surgery, and the length of time after surgery.
Current evidence from studies suggests that developing erections is important, however, these studies have been small, and the evidence is not definite. Animal studies suggest that erection medication (Viagra, Levitra, Cialis) may protect erection tissue, even in the absence of erections. However, the correct treatment plan is unknown. For example, how often does a man need to take sildenafil (Viagra®) to protect his erectile function or to maximize his erectile function recovery? Is only using erection medication enough for erectile function recovery? Would penile injections, which almost ensure production of an erection, be better than using sildenafil (Viagra®), or might a combination be even better at helping recovery of erections? These are types of questions this study might answer.
| Condition | Intervention |
|---|---|
|
Penile Cancer Erectile Dysfunction Radical Prostatectomy |
Drug: Placebo QHS and sildenafil and questionnaires Drug: Sildenafil and questionnaire Drug: Trimix combination (Papavarine 30mg/Phentholamine 1mg/Prostaglandin E1 10 mcgs/ml) and questionnaires |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Single Blind (Subject), Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Randomized Trial of Pharmacological Penile Rehabilitation in the Preservation of Erectile Function Following Bilateral Nerve-Sparing Radical Prostatectomy |
| Estimated Enrollment: | 100 |
| Study Start Date: | August 2009 |
| Estimated Study Completion Date: | August 2012 |
| Estimated Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
PRN Sildenafil: Experimental
Placebo QHS (blinded) and sildenafil 100mgs (open-label) as required for sexual relations. The placebo will be omitted on nights that 100mgs is used. Placebo will start within 24-48 hours post-surgery.
|
Drug: Placebo QHS and sildenafil and questionnaires
Pts will be offered sildenafil 100 mg to be used before intercourse on an as-required basis. They will be given six 100 mg doses, per month, for a 12-month duration. Each patient in this group will use a placebo pill (blinded) each night, except on a nights that 100mg is taken for the purpose of sexual relations. Patients will be evaluated in the clinic and will complete the questionnaires at baseline (pre-treatment evaluation), 3, 6, 9, 12, 18 and 24 months after the operation. At 12 months postoperatively, all patients will stop treatment. Visits 3, 6, 9, 12, 18, and 24 months will have ±2 week window.
|
|
Nightly Sildenafil Arm: Experimental
Patients will be instructed to take sildenafil 50 mg QHS (blinded) except on nights that they are interested in sexual relations, they will then be instructed to use sildenafil 100mgs (open-label) and skip the 50mg dose. Sildenafil treatment will start within 24-48 hours post-surgery.
|
Drug: Sildenafil and questionnaire
Patients will be instructed to take sildenafil 50 mg QHS (blinded) except on nights that they are interested in sexual relations, they will then be instructed to use sildenafil 100mgs (open-label) and skip the 50mg dose. Sildenafil treatment will start within 24-48 hours post-surgery. Patients will be evaluated in the clinic and will complete the questionnaires at baseline (pre-treatment evaluation), 3, 6, 9, 12, 18 and 24 months after the operation. At 12 months postoperatively, all patients will stop treatment. Visits 3, 6, 9, 12, 18, and 24 months will have ±2 week window
|
|
Combination Therapy Arm: Experimental
Trimix combination (Papavarine 30mg/Phentholamine 1mg/Prostaglandin E1 10 mcgs/ml), at initial dose of 5 units (0.05ml) will be given; the first 2 injections will be done in the MSKCC urology outpatient clinic (if needed, the investigator can determine appropriate amount of injections for patient training).
|
Drug: Trimix combination (Papavarine 30mg/Phentholamine 1mg/Prostaglandin E1 10 mcgs/ml) and questionnaires
Intracavernous injections of a trimix combination (Papaverine 30mg/Phentholamine 1mg/Prostaglandin E1 10 mcgs/ml) will be injected three times a week, and sildenafil 50mgs (blinded) taken on the other four (non-injection) nights. Injection therapy can be used for the purpose of sexual relations. Patients will be evaluated in the clinic and will complete the questionnaires at baseline (pre-treatment evaluation), 3, 6, 9, 12, 18 and 24 months after the operation. At 12 months postoperatively, all patients will stop treatment. Visits 3, 6, 9, 12, 18, and 24 months will have ±2 week window.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Any contraindications to sildenafil:
Exclusion Criteria:
Contacts and Locations| Contact: John Mulhall, MD | 646-422-4359 | |
| Contact: Peter Scardino, MD |
| United States, New York | |
| Memorial Sloan Kettering Cancer Center | Recruiting |
| New York, New York, United States, 10065 | |
| Contact: John Mulhall, MD | |
| Principal Investigator: | John Mulhall, MD | Memorial Sloan-Kettering Cancer Center |
More Information
| Responsible Party: | Memorial Sloan-Kettering Cancer Center ( John Mulhall, MD ) |
| Study ID Numbers: | 09-005 |
| Study First Received: | August 7, 2009 |
| Last Updated: | September 29, 2009 |
| ClinicalTrials.gov Identifier: | NCT00955929 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Penis PLACEBO SILDENAFIL CITRATE TRIMIX |
Viagra 09-005 Erectile Dysfunction following Bilateral Nerve-Sparing |
|
Alprostadil Vasodilator Agents Genital Neoplasms, Male Molecular Mechanisms of Pharmacological Action Hematologic Agents Urogenital Neoplasms Fibrinolytic Agents Fibrin Modulating Agents Sexual Dysfunction, Physiological Neoplasms by Site Mental Disorders Therapeutic Uses Penile Neoplasms |
Sexual Dysfunctions, Psychological Sildenafil Enzyme Inhibitors Cardiovascular Agents Genital Diseases, Male Sexual and Gender Disorders Penile Diseases Pharmacologic Actions Neoplasms Phosphodiesterase Inhibitors Platelet Aggregation Inhibitors Erectile Dysfunction |
