Study Stopped
Accrual too slow
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
3 other identifiers
interventional
110
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 prostate-cancer
Started Jan 2006
Typical duration for phase_3 prostate-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2006
CompletedFirst Submitted
Initial submission to the registry
October 13, 2007
CompletedFirst Posted
Study publicly available on registry
October 16, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2012
CompletedResults Posted
Study results publicly available
January 2, 2019
CompletedJanuary 2, 2019
December 1, 2018
6.3 years
October 13, 2007
January 15, 2018
December 10, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Potency Rates With or Without Assistance in the Control Group Versus Maintenance MUSE or Maintenance Viagra
At 6 and 18 months
SHIMS-5 Scores in the Control Groups Versus Maintenance MUSE or Maintenance Viagra Groups
At 1, 3, 6, 9, 12, and 18 months
Penile Length
At pre-treatment and 18 months
Study Arms (3)
Sildenafil Citrate/Mo+Aprostadil/day
EXPERIMENTALPatients 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 COMPARATORPatients 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
EXPERIMENTALPatients 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.
Interventions
Given orally
Given intraurethrally
Undergo prostatectomy
Ancillary studies
Ancillary studies
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
City of Hope
Duarte, California, 91010, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
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.
Results Point of Contact
- Title
- Laura Crocitto, M.D.
- Organization
- City of Hope
Study Officials
- PRINCIPAL INVESTIGATOR
Laura Crocitto
City of Hope Medical Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 13, 2007
First Posted
October 16, 2007
Study Start
January 1, 2006
Primary Completion
April 1, 2012
Study Completion
April 1, 2012
Last Updated
January 2, 2019
Results First Posted
January 2, 2019
Record last verified: 2018-12