Prostate CancerEarly Phase 1NCT00952666
Transrectal Ultrasound Imaging of the Prostate Gland and Neurovascular Bundles During Robot-Assisted Laparoscopic Radical Prostatectomy
A Early Phase 1 study testing TRUS-RALRP in people with Prostate Cancer, run by Johns Hopkins University at 1 site in United States.
Trial summary
Neurovascular bundle (NVB) contains capsular vessels to the prostate and cavernous nerves that provides the macroscopic landmark used during nerve-sparing radical prostatectomy. The preservation of NVB during radical prostatectomy improves postoperative recovery of potency and continence. Read more about this study
- Who is it for?
- Ages 35 to 75 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- TRUS-RALRP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2008to Dec 2009
- Phase
- Early Phase 1
- 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 35 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for a Laparoscopic Radical Prostatectomy operation
- Patients must be between the ages of 35 and 75
- Patients must not have one of the above listed exclusion criteria
- Patients must be able to understand and willing to adhere to the study protocol
Who cannot join
- Patients less than 35 years of age and over 75 years of age
- Patients with previous rectal surgery
- Patients with anal stenosis that prevents the TRUS probe insertion
- Patients with extensive abdominal surgery
- Patients with inadequate bowel prep
- Patients who are unwilling or unable to sign informed consent
- Patients on anticoagulation medication (e.g., coumadin, lovenox, or heparin)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Transrectal Ultrasound (TRUS) Imaging of the Prostate Gland and Neurovascular Bundles (NVB) During Robot-Assisted Laparoscopic Radical Prostatectomy (RALRP)
Neurovascular bundle (NVB) contains capsular vessels to the prostate and cavernous nerves that provides the macroscopic landmark used during nerve-sparing radical prostatectomy. The preservation of NVB during radical prostatectomy improves postoperative recovery of potency and continence. However, the visualization of the NVB during radical prostatectomy can be challenging.
Recently, an attempt has been made to use a transrectal ultrasound (TRUS) imaging to delineate the anatomy of the prostate gland and NVB during laparoscopic radical prostatectomy. However, it is difficult to obtain a steady image of TRUS with an operator. The investigators plan to perform a feasibility study to obtain TRUS imaging of the prostate and NVB during robot-assisted laparoscopic radical prostatectomy (RALRP). The investigators plan to use a robot-assisted TRUS probe holder to gently manipulate the probe to obtain steady TRUS images that may aid in visualization and dissection of the NVB during RALRP.
Read the detailed description
During surgery for prostate cancer, precise resection of the tumor-containing prostate gland and preservation of the neurovascular bundle (NVB) are critical in preventing tumor recurrence and potency preservation following surgery. However, due to the periprostatic connective tissues and bleeding, it is difficult to visualize NVB during surgery, even with surgical loupes or laparoscopic magnification.
Ultrasound (US) is commonly used in imaging the prostate during diagnostic and therapeutic procedures such as diagnostic biopsy. US image in addition to the classic laparoscopic imaging can potentially provide decreased surgical margins and improve the dissection of the NVB during laparoscopic radical prostatectomy (LRP) according to the study by the Cleveland Clinic group. In their study, an assistant manipulated the TRUS probe under the direction of the surgeon and held it in place as requested. At critical points of the surgery, the surgeon visualized the NVB on the Doppler-capable ultrasound monitor. The images, however, were difficult to interpret because the surgeon was not in direct control of the TRUS probe. In addition, it was challenging for surgeon to communicate with the assistant to obtain steady and useful image. Moreover, their study was performed exclusively in LRP without the daVinci® robot (Intuitive Surgical, Inc.), more commonly performed surgical approach for radical prostatectomy.
To overcome these obstacles in the study by Ukimura and al., we propose to use a mechanical support arm for holding and manipulating the TRUS probe during the daVinci® robot-assisted laparoscopic radical prostatectomy (robotic LRP)..
This application is for a feasibility study involving six patients. We will obtain TRUS images of the prostate and NVB during a robotic LRP procedure. These images will be acquired in the first part of the operation and performed with minimal interference to the operation. We will record and analyze the TRUS images to investigate the feasibility of using mechanical support arm for the TRUS probe. The proposed study is a proof of concept for a following protocol.
- Conditions
- Prostate Cancer
- Being tested
- TRUS-RALRP
- Keywords
- Prostate Cancer, Transrectal Ultrasound Imaging of Prostate, Neurovascular Bundles, Robot Assisted Laparoscopic Radical Prostatectomy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TRUS-RALRPDevice
Also called TRUS support arm with daVinci robot
During surgery, and part of this research study, the ultrasound probe (TRUS) will be placed in the rectum. Then, using the mechanical support arm to hold and adjust the probe we will take ultrasound images during a portion of the robotic LRP surgery. The ultrasound probe will then be removed, and we will complete the LRP surgery as we usually do. We expect this to add approximately 20 minutes to the regular surgery time; the maximum added time will be 30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Device | Experimental | Both the Robot-Assisted Laparoscopic Radical Prostatectomy (RALRP) and the Transrectal Ultrasound (TRUS) are common performed procedures, but are normally performed separately. In this proposed feasibility study, the procedures will be combined. Receives: Device: TRUS-RALRP |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2009 (estimated)
- Study startNov 2008
- Primary completionDec 2009
- Study completionDec 2009
Why it stopped: The number of participants needed for this study has been met.
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 Johns Hopkins UniversityThe 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Investigators
- Misop Han, M.D., M.S., Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00952666
- Sponsor's protocol ID
- NA_00014120
- Status last verified
- Aug 2009
- First submitted
- 4 Aug 2009
- Last updated
- 13 Sep 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transrectal Ultrasound (TRUS) Imaging of the Prostate Gland and Neurovascular Bundles (NVB) During Robot-Assisted Laparoscopic Radical Prostatectomy (RALRP)
- ClinicalTrials.gov ID
- NCT00952666
- Acronym / sponsor ID
- NA_00014120
- Conditions
- Prostate Cancer
- Keywords
- Prostate Cancer, Transrectal Ultrasound Imaging of Prostate, Neurovascular Bundles, Robot Assisted Laparoscopic Radical Prostatectomy
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The number of participants needed for this study has been met.
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 6 Aug 2009 (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.
Neurovascular bundle (NVB) contains capsular vessels to the prostate and cavernous nerves that provides the macroscopic landmark used during nerve-sparing radical prostatectomy. The preservation of NVB during radical prostatectomy improves postoperative recovery of potency and continence. However, the visualization of the NVB during radical prostatectomy can be challenging.
Recently, an attempt has been made to use a transrectal ultrasound (TRUS) imaging to delineate the anatomy of the prostate gland and NVB during laparoscopic radical prostatectomy. However, it is difficult to obtain a steady image of TRUS with an operator. The investigators plan to perform a feasibility study to obtain TRUS imaging of the prostate and NVB during robot-assisted laparoscopic radical prostatectomy (RALRP). The investigators plan to use a robot-assisted TRUS probe holder to gently manipulate the probe to obtain steady TRUS images that may aid in visualization and dissection of the NVB during RALRP.
Detailed description
During surgery for prostate cancer, precise resection of the tumor-containing prostate gland and preservation of the neurovascular bundle (NVB) are critical in preventing tumor recurrence and potency preservation following surgery. However, due to the periprostatic connective tissues and bleeding, it is difficult to visualize NVB during surgery, even with surgical loupes or laparoscopic magnification.
Ultrasound (US) is commonly used in imaging the prostate during diagnostic and therapeutic procedures such as diagnostic biopsy. US image in addition to the classic laparoscopic imaging can potentially provide decreased surgical margins and improve the dissection of the NVB during laparoscopic radical prostatectomy (LRP) according to the study by the Cleveland Clinic group. In their study, an assistant manipulated the TRUS probe under the direction of the surgeon and held it in place as requested. At critical points of the surgery, the surgeon visualized the NVB on the Doppler-capable ultrasound monitor. The images, however, were difficult to interpret because the surgeon was not in direct control of the TRUS probe. In addition, it was challenging for surgeon to communicate with the assistant to obtain steady and useful image. Moreover, their study was performed exclusively in LRP without the daVinci® robot (Intuitive Surgical, Inc.), more commonly performed surgical approach for radical prostatectomy.
To overcome these obstacles in the study by Ukimura and al., we propose to use a mechanical support arm for holding and manipulating the TRUS probe during the daVinci® robot-assisted laparoscopic radical prostatectomy (robotic LRP)..
This application is for a feasibility study involving six patients. We will obtain TRUS images of the prostate and NVB during a robotic LRP procedure. These images will be acquired in the first part of the operation and performed with minimal interference to the operation. We will record and analyze the TRUS images to investigate the feasibility of using mechanical support arm for the TRUS probe. The proposed study is a proof of concept for a following protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Device | Experimental | Device: TRUS-RALRPBoth the Robot-Assisted Laparoscopic Radical Prostatectomy (RALRP) and the Transrectal Ultrasound (TRUS) are common performed procedures, but are normally performed separately. In this proposed feasibility study, the procedures will be combined. |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients scheduled for a Laparoscopic Radical Prostatectomy operation
- Patients must be between the ages of 35 and 75
- Patients must not have one of the above listed exclusion criteria
- Patients must be able to understand and willing to adhere to the study protocol
Key exclusion criteria (7 listed)
- Patients less than 35 years of age and over 75 years of age
- Patients with previous rectal surgery
- Patients with anal stenosis that prevents the TRUS probe insertion
- Patients with extensive abdominal surgery
- Patients with inadequate bowel prep
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 |
|---|---|---|
| TRUS-RALRPAlso: TRUS support arm with daVinci robotDuring surgery, and part of this research study, the ultrasound probe (TRUS) will be placed in the rectum. Then, using the mechanical support arm to hold and adjust the probe we will take ultrasound images during a portion of the robotic LRP surgery. The ultrasound probe will then be removed, and we will complete the LRP surgery as we usually do. We expect this to add approximately 20 minutes to the regular surgery time; the maximum added time will be 30 minutes. | Device | Device |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: The number of participants needed for this study has been met.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2010.
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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.
Misop Han, M.D., M.S. principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing TRUS-RALRP in people with Prostate Cancer, run by Johns Hopkins University 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 4 inclusion and 7 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 13 Sep 2010. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The number of participants needed for this study has been met.). Results are not available in the source record.
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.
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 13 Sep 2010.