Prostate CancerNCT04011865
Robot-assisted vs Laparoscopic Radical Prostatectomy for Prostate Cancer Treatment
A study testing Radical prostatectomy in people with Prostate Cancer, run by Binh Dan Hospital at 1 site in Vietnam.
Trial summary
This study is to compare the outcomes of robotic-assisted laparoscopic radical prostatectomy (RARP) and laparoscopic radical prostatectomy (LRP) for prostate cancer treatment in terms of perioperative surgical, functional and oncological outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Radical prostatectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteVietnam
- Study dates
- 1 Jan 2019to 31 Dec 2020
- 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
- Adult men aged 18 years and over;
- Undergoing RARP or LRP. prostatectomy for prostate cancer at Binh Dan Hospital;
- Clinically suitable for radical prostatectomy (cT1-3, No, Mo);
- Cognitively able to give written informed consent for participation;
- Elective procedure.
Who cannot join
- The patient lacks the ability to consent for themselves;
- Patients unwilling to undergo pre- and post-operative evaluation according to the protocol;
Trial locations and contacts
1 site in 1 country.
Vietnam1 site, 1 recruiting
- Recruiting
Binh Dan Hospital
Ho Chi Minh City, 700000
Hoang PC Nguyen, Associate Professor, MD, PhD, +84 913 719 346, npchoang@gmail.com
About this study
This study is to compare the outcomes of robotic-assisted laparoscopic radical prostatectomy (RARP) and laparoscopic radical prostatectomy (LRP) for prostate cancer treatment in terms of perioperative surgical, functional and oncological outcomes.
Read the detailed description
Participants will either have robotic-assisted laparoscopic radical prostatectomy (RARP) or laparoscopic radical prostatectomy (LRP) as determined by the treating surgeon. All participants will undergo tests and questionnaires to determine urinary and erectile function, biopsies to determine perioperative surgical, functional and oncological outcomes. These assessments will be conducted pre-operatively, post-operatively and at certain follow-up time points up to 12 months.
- Conditions
- Prostate Cancer
- Being tested
- Radical prostatectomy
- Keywords
- laparoscopic radical prostatectomy, robotic-assisted laparoscopic radical prostatectomy, prostate cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radical prostatectomyProcedure or surgery
The patients diagnosed with prostate cancer (local or locally advanced stages) will be allocated to the study for performing radical prostatectomy surgery.
| Study group | Role | What they receive |
|---|---|---|
| Robotic-assisted surgery | Active comparator | Not described Receives: Procedure: Radical prostatectomy |
| Laparoscopic surgery | Sham comparator | Not described Receives: Procedure: Radical prostatectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The console time
The time which surgeon spends on the robot console by minuite
Measured: During the surgery
Mean of blood loss
Milliliter
Measured: During the surgery
Perioperative transfusion rate (%)
The number of cases which will be transfused.
Measured: Up to 1 month after operation
The rate of positive surgical margins, extracapsular extension, seminal vesicle invasion, (5)perineural invasion, the number of lymph node yield and node involvement,
Number of cases, based on the result of pathology.
Measured: Up to 1 week after operation
Number of blood units transfused
Milliliter
Measured: Up to 1 week after operation
the rate of conversion to open surgery, the rate of intraoperative incidents (%),
Percentage
Measured: Up to 1 weeks after the surgery.
The postoperative recovery parameters using Numeric Pain Rating Scale (NPRS),
The NPRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of pain, in a total of 10 points, higher score means worse, with 0 means no pain and 10 is the worst pain. The mean score will be calculated to reflect the post-operative pain.
Measured: Up to 3 month after surgery
Change of hemoglobin from baseline
(mg/mL)
Measured: Up to 1 week after operation
The drainage time
(day),
Measured: Up to 3 months after surgery
To assess urethral catheter time, urethral catheter time
(day)
Measured: Up to 3 months after surgery
To assess bowel movement recovery time,
(day)
Measured: Up to 1 week after surgery
To assess postoperative hospital stay
(day)
Measured: Up to 1 month after surgery
The rate of postoperative complications (including infections)
Percentage
Measured: in day 3, day 7, and 1 month after surgery.
PSA level in blood
(mg/mL)
Measured: Before operation
PSA level in blood
(mg/mL)
Measured: 6 weeks post-operation
PSA level in blood
(mg/mL)
Measured: 3 months post-operation
PSA level in blood
(mg/mL)
Measured: 6 months post-operation
PSA level in blood
(mg/mL)
Measured: 12 months post-operation
local and regional recurrences on sonography
including ultrasound when PSA rising or any indication of recurrent
Measured: through study completion, an average of 1 year
local and regional recurrences, on MRI
including MRI when PSA rising or any indication of recurrent
Measured: through study completion, an average of 1 year
local and regional recurrences, on PET Scan
including PET Scan, when PSA rising or any indication of recurrent
Measured: through study completion, an average of 1 year
Secondary outcomes (12)
Evaluating the pre and postoperative lower urinary tract symptoms using Full score of International Prostate Symptoms Scores (IPSS)
It contains seven questions related to symptoms related to BPH and one question related to the patient's perceived quality of life. The symptoms must have been experienced in the last month and each answer is scored from 0 to 5 for a maximum score of 35 points. The sum score will be calculated and the mean score will be evaluated.
Measured: Preoperative
Evaluating the pre and postoperative lower urinary tract symptoms using International Prostate Symptoms Scores (IPSS)
It contains seven questions related to symptoms related to BPH and one question related to the patient's perceived quality of life. The symptoms must have been experienced in the last month and each answer is scored from 0 to 5 for a maximum score of 35 points. The sum score will be calculated and the mean score will be evaluated.
Measured: 3 months postoperative
Evaluating the pre and postoperative lower urinary tract symptoms using Full score of International Prostate Symptoms Scores (IPSS)
It contains seven questions related to symptoms related to BPH and one question related to the patient's perceived quality of life. The symptoms must have been experienced in the last month and each answer is scored from 0 to 5 for a maximum score of 35 points. The sum score will be calculated and the mean score will be evaluated.
Measured: 6 months, postoperative
Evaluating the pre and postoperative lower urinary tract symptoms using Full score of International Prostate Symptoms Scores (IPSS)
It contains seven questions related to symptoms related to BPH and one question related to the patient's perceived quality of life. The symptoms must have been experienced in the last month and each answer is scored from 0 to 5 for a maximum score of 35 points. The sum score will be calculated and the mean score will be evaluated.
Measured: 12 months postoperative.
Erectile function assessments questionnaires and scoring using Index of Erectile Function Questionnaire, IIEF5, full score
The 15-question International Index of Erectile Function (IIEF) Questionnaire is a validated, multi-dimensional, self-administered investigation that has been found useful in the clinical assessment of erectile dysfunction and treatment outcomes in clinical trials. A score of 0-5 is awarded to each of the 15 questions that examine the 4 main domains of male sexual function: erectile function, orgasmic function, sexual desire and intercourse satisfaction. The score ranges from 22 - 25 for Normal erectile function (no ED), 17 - 21 for Mild ED, 12 - 16 for Mild to moderate ED, 8 - 11 for Moderate ED, and from 1 - 7 for Severe ED (5 - 7, if a man had no opportunity to engage in sexual activity). The mean score will be calculated.
Measured: Preoperative
Erectile function assessments questionnaires and scoring using Index of Erectile Function Questionnaire, IIEF5, full score
The 15-question International Index of Erectile Function (IIEF) Questionnaire is a validated, multi-dimensional, self-administered investigation that has been found useful in the clinical assessment of erectile dysfunction and treatment outcomes in clinical trials. A score of 0-5 is awarded to each of the 15 questions that examine the 4 main domains of male sexual function: erectile function, orgasmic function, sexual desire and intercourse satisfaction. The score ranges from 22 - 25 for Normal erectile function (no ED), 17 - 21 for Mild ED, 12 - 16 for Mild to moderate ED, 8 - 11 for Moderate ED, and from 1 - 7 for Severe ED (5 - 7, if a man had no opportunity to engage in sexual activity). The mean score will be calculated.
Measured: 3 months, postoperative
Erectile function assessments questionnaires and scoring using Index of Erectile Function Questionnaire, IIEF5, full score
The 15-question International Index of Erectile Function (IIEF) Questionnaire is a validated, multi-dimensional, self-administered investigation that has been found useful in the clinical assessment of erectile dysfunction and treatment outcomes in clinical trials. A score of 0-5 is awarded to each of the 15 questions that examine the 4 main domains of male sexual function: erectile function, orgasmic function, sexual desire and intercourse satisfaction. The score ranges from 22 - 25 for Normal erectile function (no ED), 17 - 21 for Mild ED, 12 - 16 for Mild to moderate ED, 8 - 11 for Moderate ED, and from 1 - 7 for Severe ED (5 - 7, if a man had no opportunity to engage in sexual activity). The mean score will be calculated.
Measured: 6 months, postoperative.
Erectile function assessments questionnaires and scoring using Index of Erectile Function Questionnaire, IIEF5, full score
The 15-question International Index of Erectile Function (IIEF) Questionnaire is a validated, multi-dimensional, self-administered investigation that has been found useful in the clinical assessment of erectile dysfunction and treatment outcomes in clinical trials. A score of 0-5 is awarded to each of the 15 questions that examine the 4 main domains of male sexual function: erectile function, orgasmic function, sexual desire and intercourse satisfaction. The score ranges from 22 - 25 for Normal erectile function (no ED), 17 - 21 for Mild ED, 12 - 16 for Mild to moderate ED, 8 - 11 for Moderate ED, and from 1 - 7 for Severe ED (5 - 7, if a man had no opportunity to engage in sexual activity). The mean score will be calculated.
Measured: 12 months postoperative
The quality of life questionnaires and scoring using the the Short Form (36) Health Survey questionnaire
The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. The mean score will be calculated.
Measured: Preoperative
The quality of life questionnaires and scoring using the the Short Form (36) Health Survey questionnaire
The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. The mean score will be calculated.
Measured: 3 months, postoperative.
The quality of life questionnaires and scoring using the the Short Form (36) Health Survey questionnaire
The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. The mean score will be calculated.
Measured: 6 months, postoperative
The quality of life questionnaires and scoring using the the Short Form (36) Health Survey questionnaire
The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. The mean score will be calculated.
Measured: 12 months postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2019
- Study start1 Jan 2019
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2020 (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.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Binh Dan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hung V Tran, MD, PhD, Study director, Binh Dan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04011865
- Sponsor's protocol ID
- BD022019
- Status last verified
- Jul 2020
- First submitted
- 13 May 2019
- Last updated
- 14 Jul 2020
- 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 14 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Robot-assisted vs Laparoscopic Radical Prostatectomy for Prostate Cancer Treatment
- ClinicalTrials.gov ID
- NCT04011865
- Acronym / sponsor ID
- BD022019
- Conditions
- Prostate Cancer
- Keywords
- laparoscopic radical prostatectomy, robotic-assisted laparoscopic radical prostatectomy, prostate cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Binh Dan HospitalUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 9 Jul 2019 (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.
This study is to compare the outcomes of robotic-assisted laparoscopic radical prostatectomy (RARP) and laparoscopic radical prostatectomy (LRP) for prostate cancer treatment in terms of perioperative surgical, functional and oncological outcomes.
Detailed description
Participants will either have robotic-assisted laparoscopic radical prostatectomy (RARP) or laparoscopic radical prostatectomy (LRP) as determined by the treating surgeon. All participants will undergo tests and questionnaires to determine urinary and erectile function, biopsies to determine perioperative surgical, functional and oncological outcomes. These assessments will be conducted pre-operatively, post-operatively and at certain follow-up time points up to 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Robotic-assisted surgery | Active comparator | Procedure: Radical prostatectomy |
| Laparoscopic surgery | Sham comparator | Procedure: Radical prostatectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult men aged 18 years and over;
- Undergoing RARP or LRP. prostatectomy for prostate cancer at Binh Dan Hospital;
- Clinically suitable for radical prostatectomy (cT1-3, No, Mo);
- Cognitively able to give written informed consent for participation;
- Elective procedure.
Key exclusion criteria (2 listed)
- The patient lacks the ability to consent for themselves;
- Patients unwilling to undergo pre- and post-operative evaluation according to the protocol;
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 |
|---|---|---|
| Radical prostatectomyThe patients diagnosed with prostate cancer (local or locally advanced stages) will be allocated to the study for performing radical prostatectomy surgery. | Procedure or surgery | Laparoscopic surgery, Robotic-assisted surgery |
Primary outcome
The console time
Time frame: During the surgery
The time which surgeon spends on the robot console by minuite
Mean of blood loss
Time frame: During the surgery
Milliliter
Perioperative transfusion rate (%)
Time frame: Up to 1 month after operation
The number of cases which will be transfused.
The rate of positive surgical margins, extracapsular extension, seminal vesicle invasion, (5)perineural invasion, the number of lymph node yield and node involvement,
Time frame: Up to 1 week after operation
Number of cases, based on the result of pathology.
Number of blood units transfused
Time frame: Up to 1 week after operation
Milliliter
the rate of conversion to open surgery, the rate of intraoperative incidents (%),
Time frame: Up to 1 weeks after the surgery.
Percentage
The postoperative recovery parameters using Numeric Pain Rating Scale (NPRS),
Time frame: Up to 3 month after surgery
The NPRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of pain, in a total of 10 points, higher score means worse, with 0 means no pain and 10 is the worst pain. The mean score will be calculated to reflect the post-operative pain.
Change of hemoglobin from baseline
Time frame: Up to 1 week after operation
(mg/mL)
The drainage time
Time frame: Up to 3 months after surgery
(day),
To assess urethral catheter time, urethral catheter time
Time frame: Up to 3 months after surgery
(day)
To assess bowel movement recovery time,
Time frame: Up to 1 week after surgery
(day)
To assess postoperative hospital stay
Time frame: Up to 1 month after surgery
(day)
The rate of postoperative complications (including infections)
Time frame: in day 3, day 7, and 1 month after surgery.
Percentage
PSA level in blood
Time frame: Before operation
(mg/mL)
PSA level in blood
Time frame: 6 weeks post-operation
(mg/mL)
PSA level in blood
Time frame: 3 months post-operation
(mg/mL)
PSA level in blood
Time frame: 6 months post-operation
(mg/mL)
PSA level in blood
Time frame: 12 months post-operation
(mg/mL)
local and regional recurrences on sonography
Time frame: through study completion, an average of 1 year
including ultrasound when PSA rising or any indication of recurrent
local and regional recurrences, on MRI
Time frame: through study completion, an average of 1 year
including MRI when PSA rising or any indication of recurrent
local and regional recurrences, on PET Scan
Time frame: through study completion, an average of 1 year
including PET Scan, when PSA rising or any indication of recurrent
12 secondary outcomes
Evaluating the pre and postoperative lower urinary tract symptoms using Full score of International Prostate Symptoms Scores (IPSS)
Time frame: Preoperative
Evaluating the pre and postoperative lower urinary tract symptoms using International Prostate Symptoms Scores (IPSS)
Time frame: 3 months postoperative
Evaluating the pre and postoperative lower urinary tract symptoms using Full score of International Prostate Symptoms Scores (IPSS)
Time frame: 6 months, postoperative
Evaluating the pre and postoperative lower urinary tract symptoms using Full score of International Prostate Symptoms Scores (IPSS)
Time frame: 12 months postoperative.
Erectile function assessments questionnaires and scoring using Index of Erectile Function Questionnaire, IIEF5, full score
Time frame: Preoperative
Erectile function assessments questionnaires and scoring using Index of Erectile Function Questionnaire, IIEF5, full score
Time frame: 3 months, postoperative
Erectile function assessments questionnaires and scoring using Index of Erectile Function Questionnaire, IIEF5, full score
Time frame: 6 months, postoperative.
Erectile function assessments questionnaires and scoring using Index of Erectile Function Questionnaire, IIEF5, full score
Time frame: 12 months postoperative
The quality of life questionnaires and scoring using the the Short Form (36) Health Survey questionnaire
Time frame: Preoperative
The quality of life questionnaires and scoring using the the Short Form (36) Health Survey questionnaire
Time frame: 3 months, postoperative.
The quality of life questionnaires and scoring using the the Short Form (36) Health Survey questionnaire
Time frame: 6 months, postoperative
The quality of life questionnaires and scoring using the the Short Form (36) Health Survey questionnaire
Time frame: 12 months postoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2020.
- 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.
Hung V Tran, MD, PhD study director
Binh Dan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radical prostatectomy in people with Prostate Cancer, run by Binh Dan Hospital at 1 site in Vietnam.
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 5 inclusion and 2 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 14 Jul 2020. 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 Vietnam. 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. Some participants in this study may receive a placebo. 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 Hoang PC Nguyen, Associate Professor, MD, PhD (+84 913 719 346, npchoang@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The console time (time frame: During the surgery). The study lists 21 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 14 Jul 2020.