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Pharmacological Penile Rehabilitation in the Preservation of Erectile Function Following Bilateral Nerve-Sparing Radical Prostatectomy - NCT00955929-10065(Clinical Trial 305271)



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City:  New York
State:  
NY
Zip Code: 10065
Conditions: Penile Cancer - Erectile Dysfunction - Radical Prostatectomy
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.
Study summary:
Criteria: Inclusion Criteria: - Male, must be ≥ 18 years of age, with histologically confirmed prostate adenocarcinoma, that is clinically localized to the prostate gland - Stable sexual relationship for ≥ 6 months - Open or laparoscopic bilateral nerve-sparing radical prostatectomy - Baseline score of ≥ 24 on the International Index of Erectile Function Domain (Appendix A) - Able to speak, read and write in the English language - Testosterone level of > 300 ng/dL within 90 days of surgery - Calculated CC (based on serum creatinine and BMI) of > 60 cc/min - Patient is able to walk up two flights of stairs briskly without chest pain Exclusion Criteria: - Preoperative or planned postoperative pelvic radiation therapy - Preoperative or planned postoperative androgen deprivation - Presence of Peyronie's disease at baseline - Presence of a penile prosthesis at baseline - Resection of one or both nerve bundles at surgery - Any contraindications to sildenafil: - Patient is currently using nitrates; - Presence of retinitis pigmentosa; - Presence macular degeneration; - MI or CVA within 3 months; - Patient is currently using MAOI medications - Patient is currently using penile self injection medication (Trimix, Bimix, or PGE-1) - Patient requiring sildenafil for penetration - Use of sildenafil within 30 days of consent
Study is available at: Memorial Sloan Kettering Cancer Center
New York, NY 10065
United States

Primary Contact:
John Mulhall, MD
Phone: 646-422-4359
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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Data Source: ClinicalTrials.gov
Date Processed: March 23, 2011
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