ED Recovery in Men Age </=65 Treated With Bilateral Nerve Sparing Robotic Assisted Prostatectomy for Prostate Cancer
Erectile Dysfunction Recovery in Men Age </=65 Treated With Bilateral Nerve Sparing Robotic Assisted Prostatectomy (BNS-RAP) for Prostate Cancer
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.
Study Overview
Status
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
California
-
Duarte, California, United States, 91010
- City of Hope
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: 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.
|
Ancillary studies
Ancillary studies
Other Names:
Given orally
Other Names:
Given intraurethrally
Other Names:
Undergo prostatectomy
|
|
ACTIVE_COMPARATOR: 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.
|
Ancillary studies
Ancillary studies
Other Names:
Given orally
Other Names:
Undergo prostatectomy
|
|
EXPERIMENTAL: 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.
|
Ancillary studies
Ancillary studies
Other Names:
Given orally
Other Names:
Undergo prostatectomy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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
Time Frame: 12 months following BNS-RAP
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Potency Rates With or Without Assistance in the Control Group Versus Maintenance MUSE or Maintenance Viagra
Time Frame: At 6 and 18 months
|
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
Time Frame: At 1, 3, 6, 9, 12, and 18 months
|
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
Time Frame: At pre-treatment and 18 months
|
measurement of penile length in centimeters
|
At pre-treatment and 18 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Laura Crocitto, City of Hope Medical Center
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Genital Neoplasms, Male
- Prostatic Diseases
- Sexual Dysfunctions, Psychological
- Sexual Dysfunction, Physiological
- Prostatic Neoplasms
- Erectile Dysfunction
- Molecular Mechanisms of Pharmacological Action
- Vasodilator Agents
- Urological Agents
- Enzyme Inhibitors
- Platelet Aggregation Inhibitors
- Phosphodiesterase Inhibitors
- Phosphodiesterase 5 Inhibitors
- Sildenafil Citrate
- Alprostadil
Other Study ID Numbers
- 04071
- NCI-2009-01602 (REGISTRY: NCI CTRP)
- CDR0000570272 (REGISTRY: PDQ)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.