Prostate CancerPhase 3NCT00544076
ED Recovery in Men Age </=65 Treated With Bilateral Nerve Sparing Robotic Assisted Prostatectomy for Prostate Cancer
A Phase 3 study testing sildenafil citrate, alprostadil and robotic-assisted laparoscopic surgery in people with Prostate Cancer and Male Erectile Disorder, run by City of Hope Medical Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years, men only
- Conditions the study is for
- Prostate Cancer, Male Erectile Disorder, Stage I Prostate Cancer
- What is being tested?
- sildenafil citrate, alprostadil and robotic-assisted laparoscopic surgery
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2006to Apr 2012
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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.
- 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.
- Conditions
- Prostate Cancer, Male Erectile Disorder, Stage I Prostate Cancer, Stage II Prostate Cancer
- Being tested
- sildenafil citrate, alprostadil, robotic-assisted laparoscopic surgery, quality-of-life assessment, questionnaire administration
- Medical subject headings
- Prostatic Neoplasms, Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sildenafil citrateDrug
Also called Viagra
Given orally
alprostadilDrug
Also called Caverject, MUSE, PGE1, prostaglandin E1
Given intraurethrally
robotic-assisted laparoscopic surgeryProcedure or surgery
Undergo prostatectomy
quality-of-life assessmentProcedure or surgery
Also called quality of life assessment
Ancillary studies
questionnaire administrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Sildenafil Citrate/Mo+Aprostadil/day | Experimental | 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. Receives: Drug: sildenafil citrate; Drug: alprostadil; Procedure: robotic-assisted laparoscopic surgery; Procedure: quality-of-life assessment; Other: questionnaire administration |
| Sildenafil Citrate Monthly | Active comparator | 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. Receives: Drug: sildenafil citrate; Procedure: robotic-assisted laparoscopic surgery; Procedure: quality-of-life assessment; Other: questionnaire administration |
| Daily Sildenafil Citrate | Experimental | 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. Receives: Drug: sildenafil citrate; Procedure: robotic-assisted laparoscopic surgery; Procedure: quality-of-life assessment; Other: questionnaire administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months following BNS-RAP
Secondary outcomes (3)
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
Measured: At 6 and 18 months
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.
Measured: At 1, 3, 6, 9, 12, and 18 months
Penile Length
measurement of penile length in centimeters
Measured: At pre-treatment and 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2007 (estimated)
- Study startJan 2006
- Primary completionApr 2012
- Study completionApr 2012
Why it stopped: Accrual too slow
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laura Crocitto, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00544076
- Sponsor's protocol ID
- 04071
- Other IDs
- NCI-2009-01602, CDR0000570272
- Status last verified
- Dec 2018
- First submitted
- 13 Oct 2007
- Last updated
- 2 Jan 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Erectile Dysfunction Recovery in Men Age </=65 Treated With Bilateral Nerve Sparing Robotic Assisted Prostatectomy (BNS-RAP) for Prostate Cancer
- ClinicalTrials.gov ID
- NCT00544076
- Acronym / sponsor ID
- 04071
- Conditions
- Prostate Cancer, Male Erectile Disorder, Stage I Prostate Cancer, Stage II Prostate Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Accrual too slow
- Enrolment
- 110 participants (actual)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Study start
- Jan 2006 (actual)
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 16 Oct 2007 (estimated)
- Results
- Posted 2 Jan 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVES:
- 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:
- 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.
- 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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sildenafil Citrate/Mo+Aprostadil/day | Experimental | Drug: sildenafil citrate, Drug: alprostadil, Procedure: robotic-assisted laparoscopic surgery, Procedure: quality-of-life assessment, Other: questionnaire administrationPatients 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 comparator | Drug: sildenafil citrate, Procedure: robotic-assisted laparoscopic surgery, Procedure: quality-of-life assessment, Other: questionnaire administrationPatients 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 | Experimental | Drug: sildenafil citrate, Procedure: robotic-assisted laparoscopic surgery, Procedure: quality-of-life assessment, Other: questionnaire administrationPatients 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sildenafil citrateAlso: ViagraGiven orally | Drug | Daily Sildenafil Citrate, Sildenafil Citrate Monthly, Sildenafil Citrate/Mo+Aprostadil/day |
| alprostadilAlso: Caverject, MUSE, PGE1, prostaglandin E1Given intraurethrally | Drug | Sildenafil Citrate/Mo+Aprostadil/day |
| robotic-assisted laparoscopic surgeryUndergo prostatectomy | Procedure or surgery | Daily Sildenafil Citrate, Sildenafil Citrate Monthly, Sildenafil Citrate/Mo+Aprostadil/day |
| quality-of-life assessmentAlso: quality of life assessmentAncillary studies | Procedure or surgery | Daily Sildenafil Citrate, Sildenafil Citrate Monthly, Sildenafil Citrate/Mo+Aprostadil/day |
| questionnaire administrationAncillary studies | Other | Daily Sildenafil Citrate, Sildenafil Citrate Monthly, Sildenafil Citrate/Mo+Aprostadil/day |
Primary outcome
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
3 secondary outcomes
Potency Rates With or Without Assistance in the Control Group Versus Maintenance MUSE or Maintenance Viagra
Time frame: 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
Penile Length
Time frame: At pre-treatment and 18 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Prostate Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Active, not recruitingObservational study
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
Prostate Cancer
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura Crocitto principal investigator
City of Hope Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing sildenafil citrate, alprostadil and robotic-assisted laparoscopic surgery in people with Prostate Cancer and Male Erectile Disorder, run by City of Hope Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Jan 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2019.