Prostate CAICG-RARPNCT06748742
A Randomized Controlled Trial to Improve the Therapeutic Effect of Robot-assisted Radical Prostatectomy (RARP) Using Indocyanine Green Fluorescence Imaging
An observational study of Prostate CA, run by Liu Cheng at 1 site in China.
Trial summary
In Robotic Assistant Radical Prostatectomy (RARP), indocyanine green fluorescent solution is injected through the urethra, and the position and structure of the urethra are observed using the fluorescence imaging equipment that comes with the device. Read more about this study
- Who is it for?
- Ages 18 to 85 years, men only
- Conditions the study is for
- Prostate CA
- What is being tested?
- In robot-assisted radical prostatectomy, indocyanine green fluorescent solution is injected through the urethra, and the position and structure of the urethra are observed by the device
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 26 Nov 2024to 31 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 85 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Patients who meet all the inclusion criteria and have no exclusion criteria for any of the conditions
Who may be able to join
- Patients diagnosed with prostate cancer who underwent robot-assisted radical prostatectomy at Shanghai First People's Hospital Patients with naïve localized prostate cancer or locally advanced prostate cancer The patient > 18 years and < 85 years Before the surgery, the prostate MR scan sagittal view of the prostate in our hospital measured the separation of the bladder neck < 1cm The patient underwent robot-assisted laparoscopic radical resection of the prostate malignancy in our hospital with anterior approach The patient returned to normal after surgery, and there were no postoperative complications such as intestinal obstruction that affected the patient's blood routine and biochemical indicators
Who cannot join
- Patients with metastatic prostate cancer Patients without preoperative puncture pathology Patients with sagittal bladder neck separation ≥ 1cm of prostate MR non-contrast prostate in our hospital before surgery Patients with preoperative examinations confirming that the enlarged prostate protrudes into the bladder floor Patients with preoperative examination confirming that the lesion is located at the tip of the prostate and near the bladder neck Patients with tumor stage reaching cT4 stage and possible invasion of bladder neck Patients who have undergone adjuvant therapy such as endocrine therapy and radiotherapy before surgery Patients with a history of any prostate surgery other than needle biopsy prior to radical resection of prostate malignancy Patients who have undergone resection of transurethral bladder lesions Patients who have undergone abdominal/pelvic surgery that makes it difficult to separate the prostate and surrounding structures during RARP Patients undergoing extended pelvic lymph node dissection during surgery Patients with posterior approach during surgery Patients with poor urinary continence due to any non-surgical factors after surgery Patients with a history of ICG allergy
Trial locations and contacts
1 site in 1 country.
About this study
In Robotic Assistant Radical Prostatectomy (RARP), indocyanine green fluorescent solution is injected through the urethra, and the position and structure of the urethra are observed using the fluorescence imaging equipment that comes with the device. Guided by real-time fluorescence imaging, the urethra is precisely dissected and severed in front of the bladder neck. Through this improved operation, the bladder neck is protected, the neck injury that is common in conventional surgical operations is reduced, and the reconstructive surgical operations necessary after loss are reduced, and the surgical efficiency is improved. By protecting the bladder neck, the sphincter is better preserved, postoperative urinary incontinence is reduced, and the surgical outcome is improved
- Conditions
- Prostate CA
- Being tested
- In robot-assisted radical prostatectomy, indocyanine green fluorescent solution is injected through the urethra, and the position and structure of the urethra are observed by the device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In robot-assisted radical prostatectomy, indocyanine green fluorescent solution is injected through the urethra, and the position and structure of the urethra are observed by the deviceDrug
In robot-assisted radical prostatectomy, indocyanine green fluorescent solution is injected through the urethra, and the position and structure of the urethra are observed by using the fluorescence imaging equipment that comes with the device. Guided by real-time fluorescence imaging, the urethra is precisely dissected and severed in front of the bladder neck. Through this improved operation, the bladder neck is protected, the neck injury that is common in conventional surgical operations is reduced, and the reconstructive surgical operations necessary after loss are reduced, and the surgical efficiency is improved. By protecting the bladder neck, the sphincter is better preserved, postoperative urinary incontinence is reduced, and the surgical outcome is improved.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Patients who underwent radical resection of prostate malignant tumor with anterior approach at Shanghai First People's Hospital | |
| Experiment Group | Patients who used ICG to identify and separate the bladder neck during anterior robot-assisted radical prostatectomy Receives: Drug: In robot-assisted radical prostatectomy, indocyanine green fluorescent solution is injected through the urethra, and the position and structure of the urethra are observed by the device |
What is being measured
The primary outcome is the main question the study is designed to answer.
The study subjects completed the follow-up results of 6 months after RARP
The resection margins of the postoperative pathology of the patients included in the study and the urinary continence at one, three, and six months follow-up after surgery; Repeat PSA values (to reflect the presence or absence of biochemical recurrence)
Measured: One month, three months, six months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2024
- Study start26 Nov 2024
- Primary completion26 Nov 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CAStudies of the same condition, open and under way.
- 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Liu Cheng
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Liu Cheng, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06748742
- Sponsor's protocol ID
- ICG-RARP
- Acronym
- ICG-RARP
- Status last verified
- Nov 2024
- First submitted
- 19 Dec 2024
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial to Improve the Therapeutic Effect of Robot-assisted Radical Prostatectomy (RARP) Using Indocyanine Green Fluorescence Imaging
- ClinicalTrials.gov ID
- NCT06748742
- Acronym / sponsor ID
- ICG-RARP / ICG-RARP
- Conditions
- Prostate CA
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Liu ChengUniversity, hospital or other
- Study start
- 26 Nov 2024 (actual)
- Primary completion
- 26 Nov 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 27 Dec 2024 (actual)
- 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.
In Robotic Assistant Radical Prostatectomy (RARP), indocyanine green fluorescent solution is injected through the urethra, and the position and structure of the urethra are observed using the fluorescence imaging equipment that comes with the device. Guided by real-time fluorescence imaging, the urethra is precisely dissected and severed in front of the bladder neck. Through this improved operation, the bladder neck is protected, the neck injury that is common in conventional surgical operations is reduced, and the reconstructive surgical operations necessary after loss are reduced, and the surgical efficiency is improved. By protecting the bladder neck, the sphincter is better preserved, postoperative urinary incontinence is reduced, and the surgical outcome is improved
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | – | –Patients who underwent radical resection of prostate malignant tumor with anterior approach at Shanghai First People's Hospital |
| Experiment Group | – | Drug: In robot-assisted radical prostatectomy, indocyanine green fluorescent solution is injected through the urethra, and the position and structure of the urethra are observed by the devicePatients who used ICG to identify and separate the bladder neck during anterior robot-assisted radical prostatectomy |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who meet all the inclusion criteria and have no exclusion criteria for any of the conditions
Key inclusion criteria (1 listed)
- Patients diagnosed with prostate cancer who underwent robot-assisted radical prostatectomy at Shanghai First People's Hospital Patients with naïve localized prostate cancer or locally advanced prostate cancer The patient > 18 years and < 85 years Before the surgery, the prostate MR scan sagittal view of the prostate in our hospital measured the separation of the bladder neck < 1cm The patient underwent robot-assisted laparoscopic radical resection of the prostate malignancy in our hospital with anterior approach The patient returned to normal after surgery, and there were no postoperative complications such as intestinal obstruction that affected the patient's blood routine and biochemical indicators
Key exclusion criteria (1 listed)
- Patients with metastatic prostate cancer Patients without preoperative puncture pathology Patients with sagittal bladder neck separation ≥ 1cm of prostate MR non-contrast prostate in our hospital before surgery Patients with preoperative examinations confirming that the enlarged prostate protrudes into the bladder floor Patients with preoperative examination confirming that the lesion is located at the tip of the prostate and near the bladder neck Patients with tumor stage reaching cT4 stage and possible invasion of bladder neck Patients who have undergone adjuvant therapy such as endocrine therapy and radiotherapy before surgery Patients with a history of any prostate surgery other than needle biopsy prior to radical resection of prostate malignancy Patients who have undergone resection of transurethral bladder lesions Patients who have undergone abdominal/pelvic surgery that makes it difficult to separate the prostate and surrounding structures during RARP Patients undergoing extended pelvic lymph node dissection during surgery Patients with posterior approach during surgery Patients with poor urinary continence due to any non-surgical factors after surgery Patients with a history of ICG allergy
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 |
|---|---|---|
| In robot-assisted radical prostatectomy, indocyanine green fluorescent solution is injected through the urethra, and the position and structure of the urethra are observed by the deviceIn robot-assisted radical prostatectomy, indocyanine green fluorescent solution is injected through the urethra, and the position and structure of the urethra are observed by using the fluorescence imaging equipment that comes with the device. Guided by real-time fluorescence imaging, the urethra is precisely dissected and severed in front of the bladder neck. Through this improved operation, the bladder neck is protected, the neck injury that is common in conventional surgical operations is reduced, and the reconstructive surgical operations necessary after loss are reduced, and the surgical efficiency is improved. By protecting the bladder neck, the sphincter is better preserved, postoperative urinary incontinence is reduced, and the surgical outcome is improved. | Drug | Experiment Group |
Primary outcome
The study subjects completed the follow-up results of 6 months after RARP
Time frame: One month, three months, six months after surgery
The resection margins of the postoperative pathology of the patients included in the study and the urinary continence at one, three, and six months follow-up after surgery; Repeat PSA values (to reflect the presence or absence of biochemical recurrence)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
Related trials for Prostate CA
Enrolling by invitationObservational study
Patient Empowerment Via Mobile Health Applications (MHAs)
Empowerment, Patient, Mobile Application
Not yet recruiting
Prostate MRI Analysis by Radiologists and Artificial Intelligence - Disease Identification and Guided Management
Prostate CA
RecruitingPhase 2
Phase II Randomized Trial of 2 Versus 5 Fraction Prostate Stereotactic Ablative Radiotherapy for Intermediate Risk Prostate Cancer
Prostate CA
RecruitingObservational study
Trans and Non-binary Prostate-Specific Antigen Reference Interval Determination Study
Prostate CA
RecruitingPhase 1
Neoadjuvant Darolutamide and Relugolix Combination Preceding Radical Prostatectomy for Prostate Cancer
Prostate CA, Prostate Cancer (Adenocarcinoma)
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.
The record lists no contact. Use the official record to reach the sponsor.
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 CA, run by Liu Cheng at 1 site in China.
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 1 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: under way, not looking for participants, as of the sponsor's last update on 27 Dec 2024. 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 China. 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?
This study is still under way. Results are not available in the source record yet.
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?
The study subjects completed the follow-up results of 6 months after RARP (time frame: One month, three months, six months after surgery). 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 Dec 2024.