Prostate Cancer AdenocarcinomaPhase 4NCT05960149
Use of Indocyanine Green in Robotic Prostate Surgeries
A Phase 4 study testing using Indocyanine Green and Nerve-sparing robot-assisted laparoscopic radical prostatectomy in people with Prostate Cancer Adenocarcinoma and Erectile Dysfunction Following Radical Prostatectomy, run by Ankara University.
Trial summary
Imaging of the vascular nerve bundle using Indocyanine Green Read more about this study
- Who is it for?
- Ages Up to 75 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Prostate Cancer Adenocarcinoma, Erectile Dysfunction Following Radical Prostatectomy
- What is being tested?
- using Indocyanine Green and Nerve-sparing robot-assisted laparoscopic radical prostatectomy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 30 Jul 2023to 31 Mar 2026
- Phase
- Phase 4
- 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 Up to 75 years
- Men only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients with low-intermediate risk prostate cancer
Who cannot join
- Patients high risk prostate cancer
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Evaluation of the Effect of Intraoperative Indocyanine Green Use on Erectile Function and Surgical Margin Positivity in Patients Undergoing Nerve-Sparing Robot-Assisted Laparoscopic Radical Prostatectomy
Imaging of the vascular nerve bundle using Indocyanine Green
Read the detailed description
Comparison of erectile function and surgical margin positivity after nerve-sparing robot-assisted laparoscopic radical prostatectomy surgery performed by imaging the vascular nerve bundle using Indocyanine Green with the results after nerve-sparing robot-assisted laparoscopic radical prostatectomy surgery without Indocyanine Green
- Being tested
- using Indocyanine Green, Nerve-sparing robot-assisted laparoscopic radical prostatectomy
- Keywords
- erectile dysfunction and indocyanine green, radical prostatectomy and indocyanine green
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
using Indocyanine GreenDrug
Also called IV Indocyanine Green injection
Nerve-sparing robot-assisted laparoscopic radical prostatectomy using Indocyanine Green
Nerve-sparing robot-assisted laparoscopic radical prostatectomyProcedure or surgery
Nerve-sparing robot-assisted laparoscopic radical prostatectomy without the use of Indocyanine Green
| Study group | Role | What they receive |
|---|---|---|
| Group using Indocyanine Green | Experimental | Performing nerve-sparing robot-assisted laparoscopic radical prostatectomy by IV injecting of Indocyanine Green Receives: Drug: using Indocyanine Green |
| The Indocyanine Green -unused group | Experimental | Nerve-sparing robot-assisted laparoscopic radical prostatectomy without the use of Indocyanine Green Receives: Procedure: Nerve-sparing robot-assisted laparoscopic radical prostatectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of erectile function.
Evaluation of erectile function after Nerve Sparing Robot Assisted Laparoscopic Radical Prostatectomy with and without the application of Indocyanine Green.Evaluation of surgical margin positivity after Nerve Sparing Robot Assisted Laparoscopic Radical Prostatectomy with and without the application of Indocyanine Green.
Both groups will evaluate their erectile function by completing the preoperative International Index of Erectile Function Every groups of participants will fill the International Index of Erectile Function -5 again after surgery in 3. -6. -9. -12 months.
The possible scores for the International Index of Erectile Function- 5 range from 0 to 30, and Erectile disfonction is classified into five categories based on the scores: severe (0-10), moderate (11-16), mild to moderate (17-21), mild (22-25), and no erectile disfonction (26-30).
Measured: up to 12 months
Evaluation of surgical margin positivity
Postoperative surgical margin positivity will be compared in both groups according to the results of the postoperative pathology report. Surgical margin positivity in both groups will be evaluated as a percentage and it will be evaluated whether there is a significant difference between the two groups
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2023
- Study start30 Jul 2023 (estimated)
- Primary completion3 Dec 2025 (estimated)
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate Cancer AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Ankara 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
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Araz Musaev, Ankara University
- Investigators
- Araz Musaev, Principal investigator, Ankara Universitry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05960149
- Sponsor's protocol ID
- A01062021Z
- Status last verified
- Jul 2023
- First submitted
- 31 May 2023
- Last updated
- 25 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Intraoperative Indocyanine Green Use on Erectile Function and Surgical Margin Positivity in Patients Undergoing Nerve-Sparing Robot-Assisted Laparoscopic Radical Prostatectomy
- ClinicalTrials.gov ID
- NCT05960149
- Acronym / sponsor ID
- A01062021Z
- Keywords
- erectile dysfunction and indocyanine green, radical prostatectomy and indocyanine green
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- 30 Jul 2023 (estimated)
- Primary completion
- 3 Dec 2025 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 25 Jul 2023 (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.
Imaging of the vascular nerve bundle using Indocyanine Green
Detailed description
Comparison of erectile function and surgical margin positivity after nerve-sparing robot-assisted laparoscopic radical prostatectomy surgery performed by imaging the vascular nerve bundle using Indocyanine Green with the results after nerve-sparing robot-assisted laparoscopic radical prostatectomy surgery without Indocyanine Green
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group using Indocyanine Green | Experimental | Drug: using Indocyanine GreenPerforming nerve-sparing robot-assisted laparoscopic radical prostatectomy by IV injecting of Indocyanine Green |
| The Indocyanine Green -unused group | Experimental | Procedure: Nerve-sparing robot-assisted laparoscopic radical prostatectomyNerve-sparing robot-assisted laparoscopic radical prostatectomy without the use of Indocyanine Green |
Who may qualify
- Ages
- Up to 75 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with low-intermediate risk prostate cancer
Key exclusion criteria (1 listed)
- Patients high risk prostate cancer
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 |
|---|---|---|
| using Indocyanine GreenAlso: IV Indocyanine Green injectionNerve-sparing robot-assisted laparoscopic radical prostatectomy using Indocyanine Green | Drug | Group using Indocyanine Green |
| Nerve-sparing robot-assisted laparoscopic radical prostatectomyNerve-sparing robot-assisted laparoscopic radical prostatectomy without the use of Indocyanine Green | Procedure or surgery | The Indocyanine Green -unused group |
Primary outcome
Evaluation of erectile function.
Time frame: up to 12 months
Evaluation of erectile function after Nerve Sparing Robot Assisted Laparoscopic Radical Prostatectomy with and without the application of Indocyanine Green.Evaluation of surgical margin positivity after Nerve Sparing Robot Assisted Laparoscopic Radical Prostatectomy with and without the application of Indocyanine Green. Both groups will evaluate their erectile function by completing the preoperative International Index of Erectile Function Every groups of participants will fill the International Index of Erectile Function -5 again after surgery in 3. -6. -9. -12 months. The possible scores for the International Index of Erectile Function- 5 range from 0 to 30, and Erectile disfonction is classified into five categories based on the scores: severe (0-10), moderate (11-16), mild to moderate (17-21), mild (22-25), and no erectile disfonction (26-30).
Evaluation of surgical margin positivity
Time frame: Up to 12 months
Postoperative surgical margin positivity will be compared in both groups according to the results of the postoperative pathology report. Surgical margin positivity in both groups will be evaluated as a percentage and it will be evaluated whether there is a significant difference between the two groups
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2023.
- Individual participant dataSharing planned: No
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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.
Araz Musaev principal investigator
Ankara Universitry
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing using Indocyanine Green and Nerve-sparing robot-assisted laparoscopic radical prostatectomy in people with Prostate Cancer Adenocarcinoma and Erectile Dysfunction Following Radical Prostatectomy, run by Ankara University.
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: status not confirmed, as of the sponsor's last update on 25 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Araz Musaev, Dr (+905364536276, msyv.araz@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of erectile function. (time frame: up to 12 months). 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 25 Jul 2023.