Prostate CancerNCT06524219
Comparison of Nerve-sparing Techniques in Radical Prostatectomy for Oncological Outcome and Functional Recovery.
An observational study of Prostate Cancer, run by The First Affiliated Hospital with Nanjing Medical University.
Trial summary
To evaluate the difference among three nerve-sparing techniques(unilateral intrafascial resection, bilateral intrafascial resection, bilateral extrafascial resection) of oncological outcome and functional recovery. Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- unilateral intrafascial resection, bilateral intrafascial resection and bilateral extrafascial resection
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2024to 1 Oct 2029
- How long will I take part?
- 3 Years
- 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 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Male patients with prostate cancer who are willing to accept nerve-sparing techniques in Retzius-sparing robot-assisted radical prostatectomy, age between 18 to 80.
Who may be able to join
- Men aged ≥18 years and ≤80 years;
- Histologically proven prostate adenocarcinoma with clinical stage < T3(no capsule break)
- Clinically localized prostate cancer in very low, low, or intermediate risk groups according to National Comprehensive Cancer Network(NCCN) guidelines (2019 v4) ;
- Eastern Cooperative Oncology Group(ECOG) score of 0 or 1;
- Life expectancy greater than 10 years;
- Patients who are willing to accept robot-assisted radical prostatectomy after informed existing treatment plan, must sign the informed consent form.
Who cannot join
- Surgeon thinks that the patient has an unresectable disease;
- patients who have already applied androgen deprivation therapy(ADT);
- Preoperative images suggest that the local lymph nodes were larger than 2 cm or suggest bone or distant metastasis;
- Any contraindication;
- Previous treatment of prostate cancer, including but not limited to surgery, hormone therapy, chemotherapy, radiotherapy, targeted therapy and immunotherapy;
- Patients with a history of transurethral resection or enucleation of the prostate;
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- Severe systemic disease that may interfere with the data, assessment, or compliance;
- Patients who are participating in other clinical trials;
- Refusing to sign the informed consent
- Patients that are considered to be not suitable to be included by the researchers.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Prospective, Multi-center, Real-world Study on the Comparison of Different Nerve-sparing Techniques in Retzius-sparing Robot-assisted Radical Prostatectomy for Oncological Outcome and Functional Recovery.
To evaluate the difference among three nerve-sparing techniques(unilateral intrafascial resection, bilateral intrafascial resection, bilateral extrafascial resection) of oncological outcome and functional recovery.
Read the detailed description
Surgery is a common and effective treatment for localized prostate cancer. The main objective of surgical treatment is to remove the tumor completely in order to achieve the goal of cure. Intrafascial nerve-sparing radical prostatectomy is a radical resection of prostate cancer with minimal damage to the nerves and blood vessels.
There are nerves around the prostate that affect sexual function, and damage to these nerves can lead to complications like sexual dysfunction and incontinence. Therefore, how to completely remove the tumor, as far as possible to preserve these nerves, become an important issue in the surgical treatment.
This study is aim to evaluate the different among nerve-sparing strategies, including unilateral intrafascial resection, bilateral intrafascial resection and bilateral extrafascial resection, on oncological outcome and functional recovery, so as to provide clinical evidence for nerve-sparing surgery of prostate cancer via robot-assisted posterior approach.
- Conditions
- Prostate Cancer
- Being tested
- unilateral intrafascial resection, bilateral intrafascial resection, bilateral extrafascial resection
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
unilateral intrafascial resectionProcedure or surgery
Conducting unilateral intrafascial resection in Retzius-sparing robot-assisted radical prostatectomy
bilateral intrafascial resectionProcedure or surgery
Conducting bilateral intrafascial resection in Retzius-sparing robot-assisted radical prostatectomy
bilateral extrafascial resectionProcedure or surgery
Conducting bilateral extrafascial resection in Retzius-sparing robot-assisted radical prostatectomy
| Study group | Role | What they receive |
|---|---|---|
| unilateral intrafascial resection | Subjects whose preoperative MRIs indicate the lesions are located in the peripheral zone of one side near the capsule, unable to be performed intrafascial resection, and no major lesion or only slight lesion in the peripheral zone of the other side, are going to be conducted unilateral intrafascial resection in Retzius-sparing robot-assisted radical prostatectomy. Receives: Procedure: unilateral intrafascial resection | |
| bilateral intrafascial resection | Subjects who have low or median-risk tumors and no extracapsular extension for major lesion, are going to be conducted bilateral intrafascial resection in Retzius-sparing robot-assisted radical prostatectomy. Receives: Procedure: bilateral intrafascial resection | |
| bilateral extrafascial resection | Subjects who have major lesion that is in the peripheral zone, MRIs that show that the lesion may invade or locate at the edge of the transitional zone, and Gleason score of 4+4 or greater, are going to be conducted bilateral intrafascial resection in Retzius-sparing robot-assisted radical prostatectomy. Receives: Procedure: bilateral extrafascial resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
biochemical recurrence-free rates
the rate of patients who do not have biochemical recurrence
Measured: 3 years
urinary control rate
the rate of patients who do not have incontinence
Measured: day 0, 3 month, 6 month, 1 year
sexual function
the rate of patients who do not lose sexual function
Measured: 6 month, 1 year
Secondary outcomes (3)
perioperative complications
the complications that occur in perioperation
Measured: perioperation
positive rate of incisal margin
the rate of patients who have positive incisal margin after the operation
Measured: day 0
prostate cancer-specific survival
the survival for prostate cancer
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2024
- Study start1 Oct 2024 (estimated)
- Primary completion1 Oct 2029 (estimated)
- Study completion1 Oct 2029 (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 The First Affiliated Hospital with Nanjing Medical 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pengfei Shao, chief physician, Principal investigator, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06524219
- Sponsor's protocol ID
- 2024-SR-394
- Status last verified
- Aug 2024
- First submitted
- 17 Jul 2024
- Last updated
- 19 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-center, Real-world Study on the Comparison of Different Nerve-sparing Techniques in Retzius-sparing Robot-assisted Radical Prostatectomy for Oncological Outcome and Functional Recovery.
- ClinicalTrials.gov ID
- NCT06524219
- Acronym / sponsor ID
- 2024-SR-394
- Conditions
- Prostate Cancer
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 Oct 2024 (estimated)
- Primary completion
- 1 Oct 2029 (estimated)
- Study completion
- 1 Oct 2029 (estimated)
- First posted
- 29 Jul 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.
To evaluate the difference among three nerve-sparing techniques(unilateral intrafascial resection, bilateral intrafascial resection, bilateral extrafascial resection) of oncological outcome and functional recovery.
Detailed description
Surgery is a common and effective treatment for localized prostate cancer. The main objective of surgical treatment is to remove the tumor completely in order to achieve the goal of cure. Intrafascial nerve-sparing radical prostatectomy is a radical resection of prostate cancer with minimal damage to the nerves and blood vessels.
There are nerves around the prostate that affect sexual function, and damage to these nerves can lead to complications like sexual dysfunction and incontinence. Therefore, how to completely remove the tumor, as far as possible to preserve these nerves, become an important issue in the surgical treatment.
This study is aim to evaluate the different among nerve-sparing strategies, including unilateral intrafascial resection, bilateral intrafascial resection and bilateral extrafascial resection, on oncological outcome and functional recovery, so as to provide clinical evidence for nerve-sparing surgery of prostate cancer via robot-assisted posterior approach.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| unilateral intrafascial resection | – | Procedure: unilateral intrafascial resectionSubjects whose preoperative MRIs indicate the lesions are located in the peripheral zone of one side near the capsule, unable to be performed intrafascial resection, and no major lesion or only slight lesion in the peripheral zone of the other side, are going to be conducted unilateral intrafascial resection in Retzius-sparing robot-assisted radical prostatectomy. |
| bilateral intrafascial resection | – | Procedure: bilateral intrafascial resectionSubjects who have low or median-risk tumors and no extracapsular extension for major lesion, are going to be conducted bilateral intrafascial resection in Retzius-sparing robot-assisted radical prostatectomy. |
| bilateral extrafascial resection | – | Procedure: bilateral extrafascial resectionSubjects who have major lesion that is in the peripheral zone, MRIs that show that the lesion may invade or locate at the edge of the transitional zone, and Gleason score of 4+4 or greater, are going to be conducted bilateral intrafascial resection in Retzius-sparing robot-assisted radical prostatectomy. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male patients with prostate cancer who are willing to accept nerve-sparing techniques in Retzius-sparing robot-assisted radical prostatectomy, age between 18 to 80.
Key inclusion criteria (6 listed)
- Men aged ≥18 years and ≤80 years;
- Histologically proven prostate adenocarcinoma with clinical stage < T3(no capsule break)
- Clinically localized prostate cancer in very low, low, or intermediate risk groups according to National Comprehensive Cancer Network(NCCN) guidelines (2019 v4) ;
- Eastern Cooperative Oncology Group(ECOG) score of 0 or 1;
- Life expectancy greater than 10 years;
Key exclusion criteria (10 listed)
- Surgeon thinks that the patient has an unresectable disease;
- patients who have already applied androgen deprivation therapy(ADT);
- Preoperative images suggest that the local lymph nodes were larger than 2 cm or suggest bone or distant metastasis;
- Any contraindication;
- Previous treatment of prostate cancer, including but not limited to surgery, hormone therapy, chemotherapy, radiotherapy, targeted therapy and immunotherapy;
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 |
|---|---|---|
| unilateral intrafascial resectionConducting unilateral intrafascial resection in Retzius-sparing robot-assisted radical prostatectomy | Procedure or surgery | unilateral intrafascial resection |
| bilateral intrafascial resectionConducting bilateral intrafascial resection in Retzius-sparing robot-assisted radical prostatectomy | Procedure or surgery | bilateral intrafascial resection |
| bilateral extrafascial resectionConducting bilateral extrafascial resection in Retzius-sparing robot-assisted radical prostatectomy | Procedure or surgery | bilateral extrafascial resection |
Primary outcome
biochemical recurrence-free rates
Time frame: 3 years
the rate of patients who do not have biochemical recurrence
urinary control rate
Time frame: day 0, 3 month, 6 month, 1 year
the rate of patients who do not have incontinence
sexual function
Time frame: 6 month, 1 year
the rate of patients who do not lose sexual function
3 secondary outcomes
perioperative complications
Time frame: perioperation
positive rate of incisal margin
Time frame: day 0
prostate cancer-specific survival
Time frame: 3 years
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 19 Aug 2024.
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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.
Pengfei Shao, chief physician principal investigator
The First Affiliated Hospital with Nanjing Medical University
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by The First Affiliated Hospital with Nanjing Medical 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 6 inclusion and 10 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: opening soon, as of the sponsor's last update on 19 Aug 2024. 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.
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?
Contact Pengfei Shao, chief physician (+86 13770561625, spf032@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
biochemical recurrence-free rates (time frame: 3 years). The study lists 3 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 19 Aug 2024.