Bladder CancerNCT04966949
Lateral Prostate Capsule Sparing Versus Nerve Sparing Robot-assisted Radical Cystectomy-orthotopic Ileal Neobladder for Bladder Cancer in the Male
A study testing lateral prostate capsule sparing or neurovascular bundles sparing in people with Bladder Cancer, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
Trial summary
To compare the perioperative, functional, and oncologic outcomes between nerve sparing and lateral prostate capsule sparing robot-assisted radical cystectomy with orthotopic ileal neobladder in male patients with bladder cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- lateral prostate capsule sparing or neurovascular bundles sparing
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2021to 31 Aug 2023
- Phase
- Interventional
- 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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male patients aged 18 or older.
- Patients those who are diagnosed with urothelial carcinoma.
- Patients those who are without tumour in the bladder neck or urethra, and prostate cancer was ruled out by MRI and serum T-PSA<2.5ng/ml.
- Patients those who are capable of receiving radical cystectomy with orthotopic ileal neobladder.
- Patients those who are able to cooperate and complete the follow-up.
- Patients those who volunteer to participate in this study and sign the informed consens.
Who cannot join
- Patients thsoe who are diagnosed distant metastasis before surgery.
- Patients those who are diagnosed with other malignancies.
- Patients those who had received pelvic radiotherapy or major pelvic operation.
Trial locations and contacts
1 site in 1 country.
China1 site
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510120
About this study
To compare the perioperative, functional, and oncologic outcomes between nerve sparing and lateral prostate capsule sparing robot-assisted radical cystectomy with orthotopic ileal neobladder in male patients with bladder cancer.
Read the detailed description
This study will enroll male patients with bladder cancer who will undergo robot-assisted radical cystectomy with orthotopic ileal neobladder. The patients will be distributed into two comparable groups according to surgical procedures: nerve sparing group and lateral prostate capsule sparing group. Patient demographics and pathologic, perioperative, functional, and oncologic outcomes will be compared between the two groups.
- Conditions
- Bladder Cancer
- Being tested
- lateral prostate capsule sparing or neurovascular bundles sparing
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lateral prostate capsule sparing or neurovascular bundles sparingProcedure or surgery
When resect the bladder and prostate, the lateral prostate capsule or neurovascular bundles will be preserved.
| Study group | Role | What they receive |
|---|---|---|
| lateral prostate capsule sparing group | Experimental | Patients will be preverved the lateral prostate capsule during the resection of bladder and prostate of the operation. Receives: Procedure: lateral prostate capsule sparing or neurovascular bundles sparing |
| nerve sparing group | Active comparator | Patients will be preverved the neurovascular bundles during the resection of bladder and prostate of the operation. Receives: Procedure: lateral prostate capsule sparing or neurovascular bundles sparing |
What is being measured
The primary outcome is the main question the study is designed to answer.
day-time continence rate
Patients were considered continent when they required 0 or 1 safety pad during the day time
Measured: 6 months
night-time continence rate
Patients were considered continent when they required 0 or 1 safety pad during the night.
Measured: 6 months
postoperative sexual function
The sexual function are evaluated by the international index of erectile function-5 (IIEF-5).
Measured: 6 months
Secondary outcomes (5)
perioperative complication rate
Measured: 3 months
operative time
Measured: 24 hours
estimated blood loss
Measured: 24 hours
overall survival
Measured: 1 year
recurrence-free survival
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2021
- Study start1 Sep 2021 (estimated)
- Primary completion31 Aug 2023 (estimated)
- Study completion31 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Sponsor type
- University, hospital or other
- Collaborators
- First Affiliated Hospital, Sun Yat-Sen University, Third Affiliated Hospital, Sun Yat-Sen University, The Seventh Affiliated Hospital of Sun Yat-sen University
- Responsible party
- Sponsor
- Investigators
- Jian Huang, MD, Principal investigator, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04966949
- Sponsor's protocol ID
- SysMU-RARC2
- Status last verified
- Jul 2021
- First submitted
- 9 Jul 2021
- Last updated
- 19 Jul 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 19 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lateral Prostate Capsule Sparing Versus Nerve Sparing Robot-assisted Radical Cystectomy-orthotopic Ileal Neobladder for Bladder Cancer in the Male
- ClinicalTrials.gov ID
- NCT04966949
- Acronym / sponsor ID
- SysMU-RARC2
- Conditions
- Bladder Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Collaborators
- First Affiliated Hospital, Sun Yat-Sen University, Third Affiliated Hospital, Sun Yat-Sen University, The Seventh Affiliated Hospital of Sun Yat-sen University
- Study start
- 1 Sep 2021 (estimated)
- Primary completion
- 31 Aug 2023 (estimated)
- Study completion
- 31 Aug 2023 (estimated)
- First posted
- 19 Jul 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.
To compare the perioperative, functional, and oncologic outcomes between nerve sparing and lateral prostate capsule sparing robot-assisted radical cystectomy with orthotopic ileal neobladder in male patients with bladder cancer.
Detailed description
This study will enroll male patients with bladder cancer who will undergo robot-assisted radical cystectomy with orthotopic ileal neobladder. The patients will be distributed into two comparable groups according to surgical procedures: nerve sparing group and lateral prostate capsule sparing group. Patient demographics and pathologic, perioperative, functional, and oncologic outcomes will be compared between the two groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| lateral prostate capsule sparing group | Experimental | Procedure: lateral prostate capsule sparing or neurovascular bundles sparingPatients will be preverved the lateral prostate capsule during the resection of bladder and prostate of the operation. |
| nerve sparing group | Active comparator | Procedure: lateral prostate capsule sparing or neurovascular bundles sparingPatients will be preverved the neurovascular bundles during the resection of bladder and prostate of the operation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male patients aged 18 or older.
- Patients those who are diagnosed with urothelial carcinoma.
- Patients those who are without tumour in the bladder neck or urethra, and prostate cancer was ruled out by MRI and serum T-PSA<2.5ng/ml.
- Patients those who are capable of receiving radical cystectomy with orthotopic ileal neobladder.
- Patients those who are able to cooperate and complete the follow-up.
Key exclusion criteria (3 listed)
- Patients thsoe who are diagnosed distant metastasis before surgery.
- Patients those who are diagnosed with other malignancies.
- Patients those who had received pelvic radiotherapy or major pelvic operation.
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 |
|---|---|---|
| lateral prostate capsule sparing or neurovascular bundles sparingWhen resect the bladder and prostate, the lateral prostate capsule or neurovascular bundles will be preserved. | Procedure or surgery | lateral prostate capsule sparing group, nerve sparing group |
Primary outcome
day-time continence rate
Time frame: 6 months
Patients were considered continent when they required 0 or 1 safety pad during the day time
night-time continence rate
Time frame: 6 months
Patients were considered continent when they required 0 or 1 safety pad during the night.
postoperative sexual function
Time frame: 6 months
The sexual function are evaluated by the international index of erectile function-5 (IIEF-5).
5 secondary outcomes
perioperative complication rate
Time frame: 3 months
operative time
Time frame: 24 hours
estimated blood loss
Time frame: 24 hours
overall survival
Time frame: 1 year
recurrence-free survival
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 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.
Jian Huang, MD principal investigator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing lateral prostate capsule sparing or neurovascular bundles sparing in people with Bladder Cancer, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University 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 6 inclusion and 3 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 19 Jul 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kaiwen Li, MD (+86-15989252628, likw6@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
day-time continence rate (time frame: 6 months). 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 Jul 2021.