Prostate Cancer Clinical Trial
Official title:
Erectile Dysfunction Recovery in Men Age </=65 Treated With Bilateral Nerve Sparing Robotic Assisted Prostatectomy (BNS-RAP) for Prostate Cancer
Verified date | December 2018 |
Source | City of Hope Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 110 |
Est. completion date | April 2012 |
Est. primary completion date | April 2012 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria - All patients undergoing BNS-RAP for prostate cancer will be asked to participate - Ability to achieve erections sufficient for intercourse prior to surgery and an SHIMS-5 score of >= 22 - Must maintain follow up care at COH for visits 1, 3, 6, 9, 12, and 18 months post surgery - Participants willing to participate on study for a minimum of 18 months - Consented participant on the Prostate database study (protocol 00149) - Patients must have a clinical stage of < T3 - Gleason score < 8 on post-operative pathological sample prior to randomization Exclusion Criteria - Metastatic disease - Coronary artery disease on nitrate therapy (including oral sublingual nitrates) - Unable to maintain follow up visits at COH at 1, 3, 6, 9, 12, and 18 months post-operatively - Pathology diagnosis >= pT3 - Prior hormonal treatment use for prostate cancer or low serum testosterone - Allergy to prostaglandin PGE1, Lidocaine, or Viagra - Gleason score >= 8 on post-operative pathological sample prior to randomization - Concomitant use of cytochrome P450 3AY inhibitors (cimetidine, erythromycin, ketoconazole, or protease inhibitors) - SHIMS-5 score =< 21 |
Country | Name | City | State |
---|---|---|---|
United States | City of Hope | Duarte | California |
Lead Sponsor | Collaborator |
---|---|
City of Hope Medical Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
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 | 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 | 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. | At 1, 3, 6, 9, 12, and 18 months | |
Secondary | Penile Length | measurement of penile length in centimeters | At pre-treatment and 18 months |
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