Prostate CancerSILRALPNCT01054001
Early Start of Oral Sildenafil 100mg for Erectile Dysfunction After Robotic Assisted Laparoscopic Radical Prostatectomy
A study testing sildenafil 100mg in people with Prostate Cancer, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial summary
The investigators try to investigate the benefit of early administration (immediately after urethral catheter removal) of sildenafil after nerve-sparing RALP for 3 months. The investigators will compare the potency rates up to 2 years after nerve-sparing RALP in men with on- demand sildenafil 100mg dosing from the… Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- sildenafil 100mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2010to Jan 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with agree to participate with the study
- Korean male subjects aged 50 years or older with clinically localized prostate cancer
- Preoperative potent men (IIEF-5 score 17 or more than 17)
- Patients in a stable, heterosexual relationship with a single partner for at least the past six months
- Suitable for nerve sparing indication
Who cannot join
- Genital anatomical deformities that would significantly impair erection
- Other sexual disorders (e.g. hypoactive sexual desire) that are considered to be the primary diagnosis when there is a coexisting diagnosis of erectile dysfunction.
- Known raised prolactin level (>3 times the upper limit of the normal range) or low free testosterone level (confirmed to be >20% below the lower limit of the normal range on blood collected between 09:00 and 11:00 hours).
- Major psychiatric disorder (including major depression or schizophrenia) that is not well controlled on treatment.
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Bundang Hospital
Seongnam, Gyeonggido, 463-707
Sang Eun Lee, Professor, 82-31-787-7349, urojsj@empal.com
Seong Jin Jeong, Professor, 82-31-787-7349, urojsj@empal.com
About this study
The investigators try to investigate the benefit of early administration (immediately after urethral catheter removal) of sildenafil after nerve-sparing RALP for 3 months. The investigators will compare the potency rates up to 2 years after nerve-sparing RALP in men with on- demand sildenafil 100mg dosing from the early postoperative period (immediately after urethral catheter removal) with from the delayed postoperative period (3 months after RP).
Read the detailed description
Various studies using animal models of CN neuroparaxia and clinical trials have demonstrated somewhat beneficial effect of PDE-5 inhibitors on smooth muscle cells of the corpus cavernosum. PDE-5 inhibitors including sildenafil have demonstrated the effectiveness in the management of postprostatectomy ED. In the animal experiments, PDE-5 inhibitors lowered the severity of the fibrosis in the corpus cavernosum of rats with CN cutting. In the clinical trials, on-demand dosing or routine dosing of PDE-5 inhibitors improved the potency rates in men received NSRP, and improvements of the potency rate did not appear to be statistically different among two dosing regimens.
But, there are few studies on the potency rate according to the start time of the administration of PDE-5 inhibitors (eg. early vs. delayed post-operative dosing). At present, it is not conclusive that whether nerve-sparing RALP provides more higher potency rate than conventional surgery in men with prostate cancers. But, with more precise dissection of CN, the robotic surgery appears to have more chances to maintain the potency in men received RP.
- Conditions
- Prostate Cancer
- Being tested
- sildenafil 100mg
- Keywords
- prostate cancer, prostatectomy, erectile dysfunction
- 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 100mgDrug
Also called Viagra 100mg
sildenafil 100mg per oral twice a week
| Study group | Role | What they receive |
|---|---|---|
| Early | Active comparator | men with on- demand sildenafil 100mg dosing from the early postoperative period Receives: Drug: sildenafil 100mg |
| Delayed | Active comparator | men with on- demand sildenafil 100mg dosing from the delayed postoperative period Receives: Drug: sildenafil 100mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
patterns of recovery of erectile functions after nerve sparing RALP in men with on- demand sildenafil 100mg dosing from the early postoperative period (using IIEF-5)
Measured: 1 year
Secondary outcomes (1)
comparison of the potency rates in men with on- demand sildenafil 100mg dosing from the early postoperative period with from the delayed postoperative period
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2010 (estimated)
- Study startJun 2010
- Primary completionDec 2012 (estimated)
- Study completionJan 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Seoul National University Bundang HospitalThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Principal investigator, Sang Eun Lee, Seoul National University Bundang Hospital
- Investigators
- Sang Eun Lee, Professor, Study chair, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01054001
- Sponsor's protocol ID
- WS486539
- Acronym
- SILRALP
- Status last verified
- Aug 2011
- First submitted
- 21 Jan 2010
- Last updated
- 22 Aug 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Start of Oral Sildenafil 100mg for Erectile Dysfunction After Robotic Assisted Laparoscopic Radical Prostatectomy
- ClinicalTrials.gov ID
- NCT01054001
- Acronym / sponsor ID
- SILRALP / WS486539
- Conditions
- Prostate Cancer
- Keywords
- prostate cancer, prostatectomy, erectile dysfunction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Jun 2010
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Jan 2013 (estimated)
- First posted
- 22 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators try to investigate the benefit of early administration (immediately after urethral catheter removal) of sildenafil after nerve-sparing RALP for 3 months. The investigators will compare the potency rates up to 2 years after nerve-sparing RALP in men with on- demand sildenafil 100mg dosing from the early postoperative period (immediately after urethral catheter removal) with from the delayed postoperative period (3 months after RP).
Detailed description
Various studies using animal models of CN neuroparaxia and clinical trials have demonstrated somewhat beneficial effect of PDE-5 inhibitors on smooth muscle cells of the corpus cavernosum. PDE-5 inhibitors including sildenafil have demonstrated the effectiveness in the management of postprostatectomy ED. In the animal experiments, PDE-5 inhibitors lowered the severity of the fibrosis in the corpus cavernosum of rats with CN cutting. In the clinical trials, on-demand dosing or routine dosing of PDE-5 inhibitors improved the potency rates in men received NSRP, and improvements of the potency rate did not appear to be statistically different among two dosing regimens.
But, there are few studies on the potency rate according to the start time of the administration of PDE-5 inhibitors (eg. early vs. delayed post-operative dosing). At present, it is not conclusive that whether nerve-sparing RALP provides more higher potency rate than conventional surgery in men with prostate cancers. But, with more precise dissection of CN, the robotic surgery appears to have more chances to maintain the potency in men received RP.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early | Active comparator | Drug: sildenafil 100mgmen with on- demand sildenafil 100mg dosing from the early postoperative period |
| Delayed | Active comparator | Drug: sildenafil 100mgmen with on- demand sildenafil 100mg dosing from the delayed postoperative period |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with agree to participate with the study
- Korean male subjects aged 50 years or older with clinically localized prostate cancer
- Preoperative potent men (IIEF-5 score 17 or more than 17)
- Patients in a stable, heterosexual relationship with a single partner for at least the past six months
- Suitable for nerve sparing indication
Key exclusion criteria (4 listed)
- Genital anatomical deformities that would significantly impair erection
- Other sexual disorders (e.g. hypoactive sexual desire) that are considered to be the primary diagnosis when there is a coexisting diagnosis of erectile dysfunction.
- Known raised prolactin level (>3 times the upper limit of the normal range) or low free testosterone level (confirmed to be >20% below the lower limit of the normal range on blood collected between 09:00 and 11:00 hours).
- Major psychiatric disorder (including major depression or schizophrenia) that is not well controlled on treatment.
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 100mgAlso: Viagra 100mgsildenafil 100mg per oral twice a week | Drug | Delayed, Early |
Primary outcome
patterns of recovery of erectile functions after nerve sparing RALP in men with on- demand sildenafil 100mg dosing from the early postoperative period (using IIEF-5)
Time frame: 1 year
1 secondary outcome
comparison of the potency rates in men with on- demand sildenafil 100mg dosing from the early postoperative period with from the delayed postoperative period
Time frame: 2 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2011.
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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.
Sang Eun Lee, Professor study chair
Seoul National University Bundang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sildenafil 100mg in people with Prostate Cancer, run by Seoul National University Bundang Hospital at 1 site in South Korea.
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 5 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 22 Aug 2011. 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 South Korea. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sang Eun SE Lee, Professor (82-31-787-7349, urojsj@empal.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
patterns of recovery of erectile functions after nerve sparing RALP in men with on- demand sildenafil 100mg dosing from the early postoperative period (using IIEF-5) (time frame: 1 year). 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 22 Aug 2011.