Prostate CancerNCT00800813
Change in Penile Length Following Bilateral Nerve-Sparing Radical Prostatectomy
An observational study of Prostate Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
Some men complain of changes in the shape or dimensions of their penis after undergoing radical prostatectomy (removal of the prostate) for prostate cancer. Changes in penile dimensions include shortening or decreased girth. Read more about this study
- Who is it for?
- Ages 21 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Penile Exam, Peyronie's Plaque and Erectile function assessment
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- How many people
- 121 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2008to Jul 2014
- Phase
- Observational
- 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 21 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing open, laparoscopic, or robotic-assisted laparoscopic radical prostatectomy at MSKCC.
Who may be able to join
- Males, age 21 years or older (no maximum age limit)
- Ability and willingness to give informed consent
- Clinically localized prostate cancer
- Open, laparoscopic or robotic-assisted radical prostatectomy
- Must be sexually active (penetrative or non-penetrative sexual encounters, either with a partner or self-stimulation)
Who cannot join
- Preoperative / Postoperative pelvic radiation therapy
- Preoperative / Postoperative hormonal treatment
- Preoperative Peyronie's disease
- Preoperative presence of a penile implant
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065
About this study
Official title: Assessing the Change in Penile Length Following Bilateral Nerve-Sparing Radical Prostatectomy
Some men complain of changes in the shape or dimensions of their penis after undergoing radical prostatectomy (removal of the prostate) for prostate cancer. Changes in penile dimensions include shortening or decreased girth. Changes in shape include a curvature or bending of the penis, and/or the appearance of indentation. These changes may be associated with formation of scar tissue involving the covering of the erection chambers, known as "plaque". The appearance of indurated plaque and a resultant curvature or indentation is a well described medical condition known as "Peyronie's Disease" and may occur in men who did or did not undergo radical prostatectomy. The purpose of this study is to evaluate these changes in penile shape and dimensions.
- Conditions
- Prostate Cancer
- Being tested
- Penile Exam, Peyronie's Plaque and Erectile function assessment
- Keywords
- Prostate, Erectile function, Peyronie's Plaque, 08-135
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Penile Exam, Peyronie's Plaque and Erectile function assessmentBehavioural
At the baseline visit, the patient's co-morbidities, height, weight with calculation of body mass index will be documented.
After surgery, the patient will be instructed to keep a diary to record erectile function including how often they use a PDE-5 inhibitor or injection therapy and each time they get an erection and the level of rigidity. The diary is required to document PDE-5 inhibitor and injection therapy use and response in each sexual encounter, unlike the IIEF questionnaire, which addresses erectile function over a 4-week period. Accurate documentation is essential for erectile function assessment, as patient choice of erectile function medication may differ in each sexual encounter, and accordingly, the achieved rigidity level.
| Study group | Role | What they receive |
|---|---|---|
| open, laparoscopic, or robotic-assisted lap | Patients will also be assessed for penile length and the presence of Peyronie's Disease at these specified times. Receives: Behavioral: Penile Exam, Peyronie's Plaque and Erectile function assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the impact of radical retropubic prostatectomy on penile dimensions.
Measured: conclusion of the study
Assess the impact of radical retropubic prostatectomy on the development of Peyronie's Disease.
Measured: conclusion of the study
Secondary outcomes (1)
Assess the association between penile length change and erectile function.
Measured: conclusion of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2008 (estimated)
- Study startNov 2008
- Primary completionJul 2014
- Study completionJul 2014
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 Memorial Sloan Kettering Cancer 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John Mulhall, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00800813
- Sponsor's protocol ID
- 08-135
- Status last verified
- Jul 2014
- First submitted
- 1 Dec 2008
- Last updated
- 14 Jul 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Change in Penile Length Following Bilateral Nerve-Sparing Radical Prostatectomy
- ClinicalTrials.gov ID
- NCT00800813
- Acronym / sponsor ID
- 08-135
- Conditions
- Prostate Cancer
- Keywords
- Prostate, Erectile function, Peyronie's Plaque, 08-135
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 2 Dec 2008 (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.
Some men complain of changes in the shape or dimensions of their penis after undergoing radical prostatectomy (removal of the prostate) for prostate cancer. Changes in penile dimensions include shortening or decreased girth. Changes in shape include a curvature or bending of the penis, and/or the appearance of indentation. These changes may be associated with formation of scar tissue involving the covering of the erection chambers, known as "plaque". The appearance of indurated plaque and a resultant curvature or indentation is a well described medical condition known as "Peyronie's Disease" and may occur in men who did or did not undergo radical prostatectomy. The purpose of this study is to evaluate these changes in penile shape and dimensions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| open, laparoscopic, or robotic-assisted lap | – | Behavioral: Penile Exam, Peyronie's Plaque and Erectile function assessmentPatients will also be assessed for penile length and the presence of Peyronie's Disease at these specified times. |
Who may qualify
- Ages
- 21 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing open, laparoscopic, or robotic-assisted laparoscopic radical prostatectomy at MSKCC.
Key inclusion criteria (5 listed)
- Males, age 21 years or older (no maximum age limit)
- Ability and willingness to give informed consent
- Clinically localized prostate cancer
- Open, laparoscopic or robotic-assisted radical prostatectomy
- Must be sexually active (penetrative or non-penetrative sexual encounters, either with a partner or self-stimulation)
Key exclusion criteria (4 listed)
- Preoperative / Postoperative pelvic radiation therapy
- Preoperative / Postoperative hormonal treatment
- Preoperative Peyronie's disease
- Preoperative presence of a penile implant
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 |
|---|---|---|
| Penile Exam, Peyronie's Plaque and Erectile function assessmentAt the baseline visit, the patient's co-morbidities, height, weight with calculation of body mass index will be documented. After surgery, the patient will be instructed to keep a diary to record erectile function including how often they use a PDE-5 inhibitor or injection therapy and each time they get an erection and the level of rigidity. The diary is required to document PDE-5 inhibitor and injection therapy use and response in each sexual encounter, unlike the IIEF questionnaire, which addresses erectile function over a 4-week period. Accurate documentation is essential for erectile function assessment, as patient choice of erectile function medication may differ in each sexual encounter, and accordingly, the achieved rigidity level. | Behavioural | open, laparoscopic, or robotic-assisted lap |
Primary outcome
Assess the impact of radical retropubic prostatectomy on penile dimensions.
Time frame: conclusion of the study
Assess the impact of radical retropubic prostatectomy on the development of Peyronie's Disease.
Time frame: conclusion of the study
1 secondary outcome
Assess the association between penile length change and erectile function.
Time frame: conclusion of the study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2014.
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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.
John Mulhall, MD principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by Memorial Sloan Kettering Cancer 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 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: finished, as of the sponsor's last update on 14 Jul 2014. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Assess the impact of radical retropubic prostatectomy on penile dimensions. (time frame: conclusion of the study). The study lists 2 primary outcomes in all. 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 14 Jul 2014.