Prostate CancerNCT00577876
Assessment of the Functional Significance of Accessory Pudendal Arteries
A study testing Trimix Injection with Doppler Ultrasound in people with Prostate Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
For patients with Prostate Cancer advances in medical technology have enabled us to identify "accessory" (additional) pudendal arteries (called APA) while performing a laparoscopic radical prostatectomy (a scope with a video camera is used during the surgery). Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Trimix Injection with Doppler Ultrasound
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2006to Oct 2011
- 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- They have selected a LRP, with or without robotic assistance, by Jonathan Colelman, MD, Bertrand Guillonneau, MD, Vincent Laudone, MD, Raul Parra, MD, or Karim Touijer MD for definitive treatment of their prostate cancer after a full discussion of treatment options.
Who cannot join
- Patients undergoing Open Radical Prostatectomy
- Patients with prior history of insulin dependent diabetes mellitus
- Patient who have received prior radiation therapy to the pelvis or prostate
- Patients requiring anticoagulation postoperatively
- Known allergy to Phenylephrine, Alprostadil, Papaverine or Phentolamine
- Patients whose systolic blood pressure is below 90 mmHg at the time of evaluation despite routine measures taken by the anesthesiologist at his best criteria.
Show all 9Show fewer
- Patients with labile hypertension or history of prior priapism
- Patients with penile scarring or penile prosthesis
- Patients with an International Index of Erectile Function score < 24
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan-Kettering Cancer Center
New York, New York, 10021
About this study
For patients with Prostate Cancer advances in medical technology have enabled us to identify "accessory" (additional) pudendal arteries (called APA) while performing a laparoscopic radical prostatectomy (a scope with a video camera is used during the surgery). APAs running near the prostate gland are identified in approximately 1 in 3 to 4 patients. However, large APAs, like the ones looked for in this study, are identified in 15-18% of all patients. These arteries are preserved more than 80% of the time, depending on their size and location.With this study, we plan to evaluate whether APAs supply blood to the penis and male erections, as well as the amount supplied.
Read the detailed description
Overall, approximately 50% of patients become impotent (inability to achieve or maintain an erect penis; also called erectile dysfunction) after radical prostatectomy (removal of the prostate). It is already known that postoperative (after surgery) erectile dysfunction does not depend solely on the preservation of the nerves going to the penis, but also to the preservation of the arteries bringing blood to the penis.
Although, the presence and frequency of APAs have been studied, and the ability to preserve them has also been noted, we still do not know how much these arteries contribute to a male's erection. With this study, we plan to evaluate whether APAs supply blood to the penis and male erections, as well as the amount supplied. While there is no immediate benefit to you for participating in the study, these findings will further help our understanding of APA's and the importance in preserving them during surgery.
The primary aim of this study is to determine the proportion of men with APAs for whom APAs contribute to penile blood flow. The secondary aim is to describe peak systolic, diastolic and resistive index velocities of the dorsal artery of the penis before and after clamping of the APA.
- Conditions
- Prostate Cancer
- Being tested
- Trimix Injection with Doppler Ultrasound
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trimix Injection with Doppler UltrasoundProcedure or surgery
In case a large APA was identified, it will be dissected following the usual technique. Upon completion of the dissection, patients will have intracavernosal injection of 10 units (0.1 ml) of a Trimix administered (PGE1 10 mcg/ml, papaverine hydrochloride 30 mg/mL and phentolamine mesylate 1mg/mL.
Once the patient achieves a pharmacologic erection, the initial Doppler Ultrasound is completed, the accessory pudendal artery will be temporarily clamped to stop blood flow. After the artery is clamped, the Doppler Ultrasound will be repeated. We estimate an extension of the surgery no longer than 5 or 10 minutes in comparison to the usual operating time. Once the Doppler Ultrasound is completed, the clamp will be removed and the surgery continued in its usual fashion.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Day of Surgery:Patient is admitted through the Preoperative Surgical Center (PSC). If a large APA is identified, then subject will continue on study Dissect APA (without any changes from what is routinely done) with a penile injection of Trimix. Once the initial Doppler Ultrasound is completed, the accessory pudendal artery will be temporarily clamped to stop blood flow. After the artery is clamped, the Doppler Ultrasound will be repeated. We estimate an extension of the surgery no longer than 5 or 10 minutes in comparison to the usual operating time. Once the Doppler Ultrasound is completed, the clamp will be removed and the surgery continued in its usual fashion. Receives: Procedure: Trimix Injection with Doppler Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the proportion of men with APAs for whom APAs contribute to penile blood flow
Measured: 18 mo
Secondary outcomes (1)
To describe peak systolic, diastolic and resistive index velocities of the dorsal artery of the penis before and after clamping of the APA.
Measured: 18 mo
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2007 (estimated)
- Study startSep 2006
- Primary completionOct 2011
- Study completionOct 2011
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 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
- NCT00577876
- Sponsor's protocol ID
- 06-073
- Status last verified
- Oct 2011
- First submitted
- 18 Dec 2007
- Last updated
- 27 Oct 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Functional Significance of Accessory Pudendal Arteries
- ClinicalTrials.gov ID
- NCT00577876
- Acronym / sponsor ID
- 06-073
- Conditions
- Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- Sep 2006
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 20 Dec 2007 (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.
For patients with Prostate Cancer advances in medical technology have enabled us to identify "accessory" (additional) pudendal arteries (called APA) while performing a laparoscopic radical prostatectomy (a scope with a video camera is used during the surgery). APAs running near the prostate gland are identified in approximately 1 in 3 to 4 patients. However, large APAs, like the ones looked for in this study, are identified in 15-18% of all patients. These arteries are preserved more than 80% of the time, depending on their size and location.With this study, we plan to evaluate whether APAs supply blood to the penis and male erections, as well as the amount supplied.
Detailed description
Overall, approximately 50% of patients become impotent (inability to achieve or maintain an erect penis; also called erectile dysfunction) after radical prostatectomy (removal of the prostate). It is already known that postoperative (after surgery) erectile dysfunction does not depend solely on the preservation of the nerves going to the penis, but also to the preservation of the arteries bringing blood to the penis.
Although, the presence and frequency of APAs have been studied, and the ability to preserve them has also been noted, we still do not know how much these arteries contribute to a male's erection. With this study, we plan to evaluate whether APAs supply blood to the penis and male erections, as well as the amount supplied. While there is no immediate benefit to you for participating in the study, these findings will further help our understanding of APA's and the importance in preserving them during surgery.
The primary aim of this study is to determine the proportion of men with APAs for whom APAs contribute to penile blood flow. The secondary aim is to describe peak systolic, diastolic and resistive index velocities of the dorsal artery of the penis before and after clamping of the APA.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: Trimix Injection with Doppler UltrasoundDay of Surgery:Patient is admitted through the Preoperative Surgical Center (PSC). If a large APA is identified, then subject will continue on study Dissect APA (without any changes from what is routinely done) with a penile injection of Trimix. Once the initial Doppler Ultrasound is completed, the accessory pudendal artery will be temporarily clamped to stop blood flow. After the artery is clamped, the Doppler Ultrasound will be repeated. We estimate an extension of the surgery no longer than 5 or 10 minutes in comparison to the usual operating time. Once the Doppler Ultrasound is completed, the clamp will be removed and the surgery continued in its usual fashion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- They have selected a LRP, with or without robotic assistance, by Jonathan Colelman, MD, Bertrand Guillonneau, MD, Vincent Laudone, MD, Raul Parra, MD, or Karim Touijer MD for definitive treatment of their prostate cancer after a full discussion of treatment options.
Key exclusion criteria (9 listed)
- Patients undergoing Open Radical Prostatectomy
- Patients with prior history of insulin dependent diabetes mellitus
- Patient who have received prior radiation therapy to the pelvis or prostate
- Patients requiring anticoagulation postoperatively
- Known allergy to Phenylephrine, Alprostadil, Papaverine or Phentolamine
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 |
|---|---|---|
| Trimix Injection with Doppler UltrasoundIn case a large APA was identified, it will be dissected following the usual technique. Upon completion of the dissection, patients will have intracavernosal injection of 10 units (0.1 ml) of a Trimix administered (PGE1 10 mcg/ml, papaverine hydrochloride 30 mg/mL and phentolamine mesylate 1mg/mL. Once the patient achieves a pharmacologic erection, the initial Doppler Ultrasound is completed, the accessory pudendal artery will be temporarily clamped to stop blood flow. After the artery is clamped, the Doppler Ultrasound will be repeated. We estimate an extension of the surgery no longer than 5 or 10 minutes in comparison to the usual operating time. Once the Doppler Ultrasound is completed, the clamp will be removed and the surgery continued in its usual fashion. | Procedure or surgery | 1 |
Primary outcome
To determine the proportion of men with APAs for whom APAs contribute to penile blood flow
Time frame: 18 mo
1 secondary outcome
To describe peak systolic, diastolic and resistive index velocities of the dorsal artery of the penis before and after clamping of the APA.
Time frame: 18 mo
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 27 Oct 2011.
- Memorial Sloan-Kettering Cancer CenterLink provided by the sponsor.
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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?
A study testing Trimix Injection with Doppler Ultrasound in people with 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 1 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: finished, as of the sponsor's last update on 27 Oct 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 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?
To determine the proportion of men with APAs for whom APAs contribute to penile blood flow (time frame: 18 mo). 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 27 Oct 2011.