Prostate CancerCGMH-SPEAR-PNCT05403190
The Performance of da Vinci SP System on Extraperitoneal Approach Radical Prostatectomy
A study testing da Vinci SP system in people with Prostate Cancer, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
The objective of this study is to evaluate the performance and safety of da Vinci Single Port (SP) system on the surgery for extraperitoneal approach radical prostatectomy Read more about this study
- Who is it for?
- Ages 18 to 78 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- da Vinci SP system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Aug 2022to 30 Nov 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 to 78 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with biopsy-proved prostate cancer
- Stage clinical T1-T2N0M0
- Prostate volume ≦ 70cm (by transrectal ultrasound or other image studies)
- BMI ≦ 35 kg/m
- Low priority of nerve sparing (pre-op sexual dysfunction or don't care about sexual function)
- Age between 18 and 78 years old
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- Suitable for minimally invasive surgery
- Patients willing and able to provide informed consent
- Patients willing and able to comply with study protocol requirements and follow-up
Who cannot join
- Previous abdominal or pelvic major operation history
- Previous radiation treatment to the pelvic area
- Patients received transurethral resection of prostate in three months
- Severe concomitant illness that drastically shortens life expectancy or increases risk of therapeutic interventions
- Severe heart disease (NYHA functional class III-IV)
- Severe lung disease (GOLD Group C-D)
Show all 12Show fewer
- Anatomy unsuitable for endoscopic visualization or minimally invasive surgery
- Hemodynamic or respiratory instability after anesthesia
- Working space restriction (e.g. kyphosis or severe scoliosis)
- Emergency surgery
- Untreated active infection
- vulnerable populations
Trial locations and contacts
1 site in 1 country.
Hung-Jen Wang, MD contact
Taiwan1 site, 1 recruiting
- Recruiting
Chang Gung Memorial Hospital
Taoyuan City, 333
Po-Hung Lin, +886975366240, m7587@cgmh.org.tw
About this study
Official title: The Performance of da Vinci SP System on Extraperitoneal Approach Radical Prostatectomy-a Single Arm Pivotal Trial Initiated by Chang Gung Memorial Hospital, Taiwan
The objective of this study is to evaluate the performance and safety of da Vinci Single Port (SP) system on the surgery for extraperitoneal approach radical prostatectomy
Read the detailed description
Enrolled subjects would receive extraperitoneal approach radical prostatectomy using da Vinci SP system and be assessed at baseline (preoperatively), during hospitalization, and postoperatively (at 1 month +/-4 days, 3 month +/- 7 days, 6 months +/- 10 days, 12month +/-14 days). The preoperative assessment includes any diagnostic tests to confirm the subjects' cancer status and eligibility for the intervention under consideration such as transrectal or transperineal biopsy, image studies for staging including MRI/CT and bone scan, and cardiopulmonary tests to evaluate risks for anesthesia. The hospitalization assessment includes the collection of perioperative and postoperative details, conversions, and complications. The postoperative assessment includes regular follow up studies to evaluate cancer status and functional outcome (For sexual function, the International Index of Erectile Function (IIEF-5) would be recorded before and after the surgery. For continence, the number of pads per day and 24hr total weight of pads would be recorded. No pad used or one safe pad per day with net wet ≤ 50gm would be considered as continent. International Prostate Symptom Score (IPSS) wound be recorded before and after the surgery to access voiding function).
- Conditions
- Prostate Cancer
- Being tested
- da Vinci SP system
- Keywords
- prostate cancer, radical prostatectomy, da Vinci SP system, extraperitoneal approach
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
da Vinci SP systemDevice
using da Vinci SP system to perform extraperitoneal approach radical prostatectomy
| Study group | Role | What they receive |
|---|---|---|
| Study arm | Experimental | Patients with prostate cancer Receives: Device: da Vinci SP system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate (%)
Percentage of successful extraperitoneal approach radical prostatectomy with da Vinci SP system (no conversion to conventional laparoscopic, multiport da Vinci surgery or open surgery; addition of access port to complete the procedure would not be considered as conversion.)
Measured: immediately after the surgery
Secondary outcomes (19)
Perioperative parameters-incision length (cm)
incision length
Measured: immediately after the surgery
Perioperative parameters-console time (minutes)
console time
Measured: immediately after the surgery
Perioperative parameters-blood loss (ml)
blood loss
Measured: immediately after the surgery
Perioperative parameters-blood transfusion type
blood transfusion type
Measured: immediately after the surgery
Perioperative parameters-blood transfusion unit
blood transfusion unit
Measured: immediately after the surgery
Perioperative parameters-intra-operative complications (SATAVA system)
intra-operative complications accessed with SATAVA system, Grade 1 to 3, higher grade indicates serious complications
Measured: immediately after the surgery
Perioperative parameters-oxidative stress
oxidative stress measured by the arterial malondialdehyde (MDA) level (micromole/L)
Measured: immediately after the surgery
Postoperative parameters-length of hospital stay (days)
length of hospital stay
Measured: immediately after discharge (assessed up to 10 days)
Postoperative parameters-pain scale (VAS score)
pain scale accessed with visual analog scale (VAS) score, 1-10, higher score indicates more pain
Measured: Every day during admission after the surgery (up to 7 days)
Postoperative parameters-analgesic type
analgesic type
Measured: Every day during admission after the surgery (up to 7 days)
Postoperative parameters-analgesic dose
analgesic dose
Measured: Every day during admission after the surgery (up to 7 days)
Postoperative parameters-postoperative complications (CLAVIEN-DINDO system)
postoperative complications accessed with CLAVIEN-DINDO system, Grade I to V, higher grade indicates severe complications
Measured: During admission after the surgery (up to 10 days)
Postoperative parameters-readmission and reoperation
Thirty-day readmission and reoperations in relation to the index procedure
Measured: If happens, on the day of re-admission or reoperations (up to 30 days)
Functional outcomes-continence status
Continence status after Foley catheter removed. Pad-free or one safe pad used are defined as continence intact. More than one pad used is defined as post-operative incontinence.
Measured: Post-operation 1/3/6/12 months
Functional outcomes-continence (pad amount)
pads used per day (for patients with incontinence)
Measured: Post-operation 1/3/6/12 months
Functional outcomes-continence (leak amount in gram)
24hr total weight of pads (for patients with incontinence)
Measured: Post-operation 1/3/6/12 months
Functional outcomes-sexual function change (IIEF-5)
sexual function at baseline and 1/3/6/12 months with International Index of Erectile Function (IIEF-5), 0-25, higher score indicates better sexual function.
Measured: Baseline, Post-operation 1/3/6/12 months
Oncologic outcomes-margin status (positive or negative)
surgical margin status
Measured: when the pathology report is available (up to day 10)
Oncologic outcomes-biochemical recurrence
biochemical recurrence (PSA level ng/ml)
Measured: Post-operation 1/3/6/12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2022
- Study start1 Aug 2022
- Primary completion31 Jul 2023 (estimated)
- Study completion30 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Intuitive Surgical
- Responsible party
- Sponsor
- Investigators
- Chun-Te Wu, Professor, MD, PhD, Principal investigator, Chang Gung Memorial Hospital at Keelung
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05403190
- Sponsor's protocol ID
- 202101419A0C601
- Acronym
- CGMH-SPEAR-P
- Status last verified
- Apr 2022
- First submitted
- 18 May 2022
- Last updated
- 22 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Lin PH, Wang HJ, Kan HC, Pang ST, Yu KJ, Wu CT. Comparable oncological and functional outcomes of robot-assisted radical prostatectomy with conventional anterior approach and Hood technique using DAVINCI SP system. Sci Rep. 2025 Nov 28;15(1):45652. doi: 10.1038/s41598-025-30245-5.
PubMed 41315721
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Performance of da Vinci SP System on Extraperitoneal Approach Radical Prostatectomy-a Single Arm Pivotal Trial Initiated by Chang Gung Memorial Hospital, Taiwan
- ClinicalTrials.gov ID
- NCT05403190
- Acronym / sponsor ID
- CGMH-SPEAR-P / 202101419A0C601
- Conditions
- Prostate Cancer
- Keywords
- prostate cancer, radical prostatectomy, da Vinci SP system, extraperitoneal approach
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Collaborators
- Intuitive Surgical
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 31 Jul 2023 (estimated)
- Study completion
- 30 Nov 2023 (estimated)
- First posted
- 3 Jun 2022 (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.
The objective of this study is to evaluate the performance and safety of da Vinci Single Port (SP) system on the surgery for extraperitoneal approach radical prostatectomy
Detailed description
Enrolled subjects would receive extraperitoneal approach radical prostatectomy using da Vinci SP system and be assessed at baseline (preoperatively), during hospitalization, and postoperatively (at 1 month +/-4 days, 3 month +/- 7 days, 6 months +/- 10 days, 12month +/-14 days). The preoperative assessment includes any diagnostic tests to confirm the subjects' cancer status and eligibility for the intervention under consideration such as transrectal or transperineal biopsy, image studies for staging including MRI/CT and bone scan, and cardiopulmonary tests to evaluate risks for anesthesia. The hospitalization assessment includes the collection of perioperative and postoperative details, conversions, and complications. The postoperative assessment includes regular follow up studies to evaluate cancer status and functional outcome (For sexual function, the International Index of Erectile Function (IIEF-5) would be recorded before and after the surgery. For continence, the number of pads per day and 24hr total weight of pads would be recorded. No pad used or one safe pad per day with net wet ≤ 50gm would be considered as continent. International Prostate Symptom Score (IPSS) wound be recorded before and after the surgery to access voiding function).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study arm | Experimental | Device: da Vinci SP systemPatients with prostate cancer |
Who may qualify
- Ages
- 18 to 78 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients with biopsy-proved prostate cancer
- Stage clinical T1-T2N0M0
- Prostate volume ≦ 70cm (by transrectal ultrasound or other image studies)
- BMI ≦ 35 kg/m
- Low priority of nerve sparing (pre-op sexual dysfunction or don't care about sexual function)
Key exclusion criteria (12 listed)
- Previous abdominal or pelvic major operation history
- Previous radiation treatment to the pelvic area
- Patients received transurethral resection of prostate in three months
- Severe concomitant illness that drastically shortens life expectancy or increases risk of therapeutic interventions
- Anatomy unsuitable for endoscopic visualization or minimally invasive surgery
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 |
|---|---|---|
| da Vinci SP systemusing da Vinci SP system to perform extraperitoneal approach radical prostatectomy | Device | Study arm |
Primary outcome
Success rate (%)
Time frame: immediately after the surgery
Percentage of successful extraperitoneal approach radical prostatectomy with da Vinci SP system (no conversion to conventional laparoscopic, multiport da Vinci surgery or open surgery; addition of access port to complete the procedure would not be considered as conversion.)
19 secondary outcomes
Perioperative parameters-incision length (cm)
Time frame: immediately after the surgery
Perioperative parameters-console time (minutes)
Time frame: immediately after the surgery
Perioperative parameters-blood loss (ml)
Time frame: immediately after the surgery
Perioperative parameters-blood transfusion type
Time frame: immediately after the surgery
Perioperative parameters-blood transfusion unit
Time frame: immediately after the surgery
Perioperative parameters-intra-operative complications (SATAVA system)
Time frame: immediately after the surgery
Perioperative parameters-oxidative stress
Time frame: immediately after the surgery
Postoperative parameters-length of hospital stay (days)
Time frame: immediately after discharge (assessed up to 10 days)
Postoperative parameters-pain scale (VAS score)
Time frame: Every day during admission after the surgery (up to 7 days)
Postoperative parameters-analgesic type
Time frame: Every day during admission after the surgery (up to 7 days)
Postoperative parameters-analgesic dose
Time frame: Every day during admission after the surgery (up to 7 days)
Postoperative parameters-postoperative complications (CLAVIEN-DINDO system)
Time frame: During admission after the surgery (up to 10 days)
Postoperative parameters-readmission and reoperation
Time frame: If happens, on the day of re-admission or reoperations (up to 30 days)
Functional outcomes-continence status
Time frame: Post-operation 1/3/6/12 months
Functional outcomes-continence (pad amount)
Time frame: Post-operation 1/3/6/12 months
Functional outcomes-continence (leak amount in gram)
Time frame: Post-operation 1/3/6/12 months
Functional outcomes-sexual function change (IIEF-5)
Time frame: Baseline, Post-operation 1/3/6/12 months
Oncologic outcomes-margin status (positive or negative)
Time frame: when the pathology report is available (up to day 10)
Oncologic outcomes-biochemical recurrence
Time frame: Post-operation 1/3/6/12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2023.
- Derived from this study: PubMed 41315721Lin PH, Wang HJ, Kan HC, Pang ST, Yu KJ, Wu CT. Comparable oncological and functional outcomes of robot-assisted radical prostatectomy with conventional anterior approach and Hood technique using DAVINCI SP system. Sci Rep. 2025 Nov 28;15(1):45652. doi: 10.1038/s41598-025-30245-5.
- 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-Jen Wang, MD contact
Chun-Te Wu, Professor, MD, PhD principal investigator
Chang Gung Memorial Hospital at Keelung
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing da Vinci SP system in people with Prostate Cancer, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 9 inclusion and 12 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 22 Feb 2023. 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 Taiwan. 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 Po-Hung Lin, MD (+886975366240, m7587@cgmh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success rate (%) (time frame: immediately after the surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05403190, which also lists 1 linked publication.
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 22 Feb 2023.