Prostate CancerPhase 4NCT04882618
Use of Indocyanine Green During Pelvic Lymph Node Dissection in Prostate Cancer.
A Phase 4 study testing Indocyanine green in people with Prostate Cancer and Lymph Node Metastases, run by TC Erciyes University at 1 site in Turkey (Türkiye).
Trial summary
Standard treatment of local or locally advanced prostate cancer is radical prostatectomy (RRP) surgery. During RRP in certain patients extended lymph node dissection (ELND) is recommended. to detect eligible patients for ELND some nomograms based on clinical factors of them is used. Read more about this study
- Who is it for?
- Ages 18 to 75 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Prostate Cancer, Lymph Node Metastases
- What is being tested?
- Indocyanine green
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 Nov 2019to 8 Nov 2021
- 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 18 to 75 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Histologically confirmed locally limited prostate cancer;
- Intermediate or high risk tumor
- Recommended and planned prostatectomy;
- Completed and signed written consent;
- Voluntarily agreement to participate in this study
- Age of the study participants ≥ 18 years.
Who cannot join
- Allergic reaction to active ingredient (indocyanine green);
- Iodine allergy;
- Hyperthyroidism;
- High-grade renal impairment;
- High-grade hepatic insufficiency;
- Unwillingness to the storage and disclosure of pseudonymous disease and personal data
- psychiatric pre-existing conditions or other circumstances that make a cooperation by the patient in question
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Department of Urology, Ercieys University, Faculty Of Medicine,
Kayseri, 38039
Abdullah Demirtas, MD, +905325094494, mesane@gmail.com
About this study
Official title: Is the Extended Lymph Node Dissection Under Indocyanine Green (ICG) Based Fluorescence Imaging Superior to Conventional Extended Lymph Node Dissection During Laparoscopic Radical Prostatectomy(LRRP)?
Standard treatment of local or locally advanced prostate cancer is radical prostatectomy (RRP) surgery. During RRP in certain patients extended lymph node dissection (ELND) is recommended. to detect eligible patients for ELND some nomograms based on clinical factors of them is used. The Briganti nomogram is one of them. If the patient has 7% or more probability on Briganti nomogram, then ELND is recommended. But ELND is complicated surgical procedure and may cause labor lost and cost.
It is aimed here to show whether the ICG based fluorescence imaging during laparoscopy may yield higher accuracy to detect metastatic LNs than the conventional ELND?
Read the detailed description
50 patients with diagnosis of local or locally advance prostate cancer and having LN invasion probability between 7-50% on 2018 Briganti Nomogram will be included to this study.
Before Laparoscopic radical prostatectomy (LRRP), ICG is injected left and right lobe of the propagate during cystoscopy.
Extended LND is performed in all patients. But before it, fluorescence imaging will be done, and ICG positive lymph nodes (LN) are dissected and sent pathology separately.
Positive LN yield pf ICG guided LND and conventional LND is compared.
- Conditions
- Prostate Cancer, Lymph Node Metastases
- Being tested
- Indocyanine green
- Keywords
- indocyanine green based fluorescence imaging, extendend lymph node dissection, prostate cancer
- Medical subject headings
- Prostatic Neoplasms, Lymphatic Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indocyanine greenDrug
Also called Conventional ELND
indocyanine green application during LRRP to detect positive lymph nodes. ICG will be injected to prostate lobes via csytoscopy
| Study group | Role | What they receive |
|---|---|---|
| ICG group | Experimental | ICG injection before LRRP via cystoscopy Receives: Drug: Indocyanine green |
What is being measured
The primary outcome is the main question the study is designed to answer.
Indocyanine green postive lymph node numbers
total number of dissected lymph nodes which are indocyanine green positive
Measured: 15 day after surgery
Total lymph node numbers of conventional extended lymph node dissection
total number of dissected lymph nodes during conventional extended lymph node dissection
Measured: 15 day after surgery
pathology of indocyanine green positive lymph nodes
İndocyanine green positvie lymph nodes are malign or benign
Measured: 15 day after surgery
pathology of lymph nodes
Pathology of material from conventional extended lymph node dissection
Measured: 15 day after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2021
- Study start8 Nov 2019
- Primary completion8 Nov 2021 (estimated)
- Study completion8 Nov 2021 (estimated)
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 TC Erciyes 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
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective single arm study
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdullah Demirtas, TC Erciyes University
- Investigators
- Abdullah A Demirtaş, Md, Prof, Principal investigator, TC Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04882618
- Sponsor's protocol ID
- TSA-2019-9393
- Status last verified
- May 2021
- First submitted
- 31 Jan 2021
- Last updated
- 12 May 2021
- Results posted
- No
- Data monitoring committee
- 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 12 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is the Extended Lymph Node Dissection Under Indocyanine Green (ICG) Based Fluorescence Imaging Superior to Conventional Extended Lymph Node Dissection During Laparoscopic Radical Prostatectomy(LRRP)?
- ClinicalTrials.gov ID
- NCT04882618
- Acronym / sponsor ID
- TSA-2019-9393
- Conditions
- Prostate Cancer, Lymph Node Metastases
- Keywords
- indocyanine green based fluorescence imaging, extendend lymph node dissection, prostate cancer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- 8 Nov 2019 (actual)
- Primary completion
- 8 Nov 2021 (estimated)
- Study completion
- 8 Nov 2021 (estimated)
- First posted
- 12 May 2021 (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.
Standard treatment of local or locally advanced prostate cancer is radical prostatectomy (RRP) surgery. During RRP in certain patients extended lymph node dissection (ELND) is recommended. to detect eligible patients for ELND some nomograms based on clinical factors of them is used. The Briganti nomogram is one of them. If the patient has 7% or more probability on Briganti nomogram, then ELND is recommended. But ELND is complicated surgical procedure and may cause labor lost and cost.
It is aimed here to show whether the ICG based fluorescence imaging during laparoscopy may yield higher accuracy to detect metastatic LNs than the conventional ELND?
Detailed description
50 patients with diagnosis of local or locally advance prostate cancer and having LN invasion probability between 7-50% on 2018 Briganti Nomogram will be included to this study.
Before Laparoscopic radical prostatectomy (LRRP), ICG is injected left and right lobe of the propagate during cystoscopy.
Extended LND is performed in all patients. But before it, fluorescence imaging will be done, and ICG positive lymph nodes (LN) are dissected and sent pathology separately.
Positive LN yield pf ICG guided LND and conventional LND is compared.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective single arm study
| Arm | Type | Receives |
|---|---|---|
| ICG group | Experimental | Drug: Indocyanine greenICG injection before LRRP via cystoscopy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Histologically confirmed locally limited prostate cancer;
- Intermediate or high risk tumor
- Recommended and planned prostatectomy;
- Completed and signed written consent;
- Voluntarily agreement to participate in this study
Key exclusion criteria (7 listed)
- Allergic reaction to active ingredient (indocyanine green);
- Iodine allergy;
- Hyperthyroidism;
- High-grade renal impairment;
- High-grade hepatic insufficiency;
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 |
|---|---|---|
| Indocyanine greenAlso: Conventional ELNDindocyanine green application during LRRP to detect positive lymph nodes. ICG will be injected to prostate lobes via csytoscopy | Drug | ICG group |
Primary outcome
Indocyanine green postive lymph node numbers
Time frame: 15 day after surgery
total number of dissected lymph nodes which are indocyanine green positive
Total lymph node numbers of conventional extended lymph node dissection
Time frame: 15 day after surgery
total number of dissected lymph nodes during conventional extended lymph node dissection
pathology of indocyanine green positive lymph nodes
Time frame: 15 day after surgery
İndocyanine green positvie lymph nodes are malign or benign
pathology of lymph nodes
Time frame: 15 day after surgery
Pathology of material from conventional extended lymph node dissection
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2021.
- 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.
Abdullah A Demirtaş, Md, Prof principal investigator
TC Erciyes University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Indocyanine green in people with Prostate Cancer and Lymph Node Metastases, run by TC Erciyes University at 1 site in Turkey (Türkiye).
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 6 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: status not confirmed, as of the sponsor's last update on 12 May 2021. 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 Turkey (Türkiye). 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?
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 Abdullah A Demirtaş, MD, PRof (+905325094494, mesane@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Indocyanine green postive lymph node numbers (time frame: 15 day after surgery). The study lists 4 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 12 May 2021.