Prostate CancerCoSMAPNCT07666217
CoSMAP Trial: SP-EA vs MP-TA Robot-Assisted Radical Prostatectomy
An observational study of Prostate Cancer, run by Intuitive Surgical at 8 sites in Japan.
Trial summary
This multicenter retrospective observational study aims to compare perioperative and postoperative outcomes between the da Vinci SP extraperitoneal approach (SP-EA) and the robotic multi-port transperitoneal approach (MP-TA) in robot-assisted radical prostatectomy for localized prostate cancer. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostate Cancer
- How many people
- 625 participants
- Where
- 8 sitesJapan
- Study dates
- 26 Mar 2026to 31 Mar 2027
- 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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with localized prostate cancer who underwent robot assisted radical prostatectomy using either the da Vinci SP extraperitoneal approach or the robotic multi port transperitoneal approach at participating institutions in Japan.
Who may be able to join
- Patients with localized prostate cancer (clinical stage T1-T3a, N0, M0) eligible for radical prostatectomy
- Patients who underwent RARP via SP-EA or MP-TA on or after January 1, 2023
- Patients with available postoperative follow-up data for ≥6 months (≥166 days) *note 1)
Who cannot join
- Patients who have expressed an intention to refuse the use of their data for this study
- Patients who underwent RARP using surgical approaches other than those specified in the inclusion criteria (e.g., transvesical approach)
- Patients who underwent RARP with pelvic lymph node dissection (PLND)
- Patients with a history of radiotherapy for prostate cancer
- Any other patients whom the principal investigator or a co-investigator deem inappropriate, such as those with missing outcome data.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Japan8 sites
Ageo Central General Hospital
Ageo, Saitama, 362-8588
Ichinomiyanishi Hospital
Ichinomiya, Aichi-ken, 494-0001
Kyoto City Hospital
Kyoto, Kyoto, 604-8845
National Cancer Center Hospital
Tokyo, Tokyo, 104-0045
Tokyo Medical Center
Tokyo, Tokyo, 152-8902
Fujita Health University Hospital
Toyoake, Aichi-ken, 470-1192
Mie University Hospital
Tsu, Mie-ken, 514-8507
Saiseikai Yokohamashi Tobu Hospital
Yokohama, Kanagawa, 230-0012
About this study
Official title: Comparison of Perioperative and Postoperative Outcomes of Single-port (SP) Extraperitoneal Approach and Multi-port (MP) Transperitoneal Approach in Robot-assisted Radical Prostatectomy：A Propensity Score-matched Retrospective Cohort Study
This multicenter retrospective observational study aims to compare perioperative and postoperative outcomes between the da Vinci SP extraperitoneal approach (SP-EA) and the robotic multi-port transperitoneal approach (MP-TA) in robot-assisted radical prostatectomy for localized prostate cancer.
Read the detailed description
This is a multicenter, retrospective, propensity score-matched observational cohort study conducted in Japan.
The study aims to compare perioperative and postoperative outcomes of robot-assisted radical prostatectomy (RARP) performed using the da Vinci SP extraperitoneal approach (SP-EA) and the robotic multi-port transperitoneal approach (MP-TA) in patients with localized prostate cancer.
Clinical data will be retrospectively and continuously collected from participating institutions and analyzed to evaluate the utility and potential clinical benefits of the SP-EA approach.
- Conditions
- Prostate Cancer
- Keywords
- Robot assisted radical prostatectomy, RARP, Single port, da Vinci SP, Extraperitoneal approach, Transperitoneal approach, Propensity score matching
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| SP-EA group | Patients who underwent robot assisted radical prostatectomy using the da Vinci SP extraperitoneal approach. | |
| MP-TA group | Patients who underwent robot assisted radical prostatectomy using the robotic multi port transperitoneal approach. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of postoperative complications and Clavien-Dindo Grade 3a or higher postoperative complications
Postoperative complications occurring after robot assisted radical prostatectomy, including complications classified as Clavien-Dindo Grade 3a or higher.
Measured: Within 6 and 12 months after surgery
Urinary continence rate
Achievement of urinary continence after robot assisted radical prostatectomy.
Measured: Within 6 and 12 months after surgery
Secondary outcomes (16)
Total operative time
Total operative time measured in minutes.
Measured: During surgery
Console time
Console time measured in minutes.
Measured: During surgery
Estimated blood loss
Estimated blood loss measured in milliliters.
Measured: During surgery
Intraoperative transfusion rate
Proportion of patients requiring blood transfusion during surgery.
Measured: During surgery
Nerve sparing rate
Proportion of patients undergoing nerve sparing procedures.
Measured: During surgery
Drain placement rate
Proportion of patients requiring surgical drain placement.
Measured: During surgery
Intraoperative complication rate
vascular injury / organ injury / nerve injury / others
Measured: During surgery
Conversion rate
Conversion to open surgery
Measured: During surgery
Positive surgical margin rate
Proportion of patients with positive surgical margins
Measured: Immediately after surgery
Length of hospital stay
Number of days from the date of surgery (Day 0) to hospital discharge.
Measured: From the date of surgery until the date of hospital discharge, assessed up to 30 days after surgery
Foley catheter duration
Number of days from the date of surgery (Day 0) to Foley catheter removal.
Measured: From the date of surgery until the date of Foley catheter removal, assessed up to 30 days after surgery
Postoperative serum PSA level
Postoperative serum prostate-specific antigen (PSA) level measured as an actual value in ng/mL
Measured: At 1, 3, 6 and 12 months after surgery
Biochemical recurrence rate
Defined as PSA ≥ 0.2 ng/mL
Measured: Within 6 and 12 months after surgery
Readmission rate
Measured: Within 6 and 12 months after surgery
Numeric Rating Scale (NRS) pain score
Numeric Rating Scale (NRS) ranging from 0 to 10, with higher scores indicating worse pain.
Measured: At hospital discharge, an average of 7 days
Sexual function score
Sexual Health Inventory for Men (SHIM), ranging from 1 to 25, with higher scores indicating better erectile function
Measured: At 6 months and 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2026
- Study start26 Mar 2026
- Primary completion30 Sep 2026 (estimated)
- Study completion31 Mar 2027 (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 Intuitive SurgicalThe 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
- Retrospective
- Enrolment
- 625 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Intuitive Surgical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Masashi Takenaka, Principal investigator, Fujita Health University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07666217
- Sponsor's protocol ID
- ISI-DV5-URO-J01(CoSMAP)
- Other IDs
- 1165953
- Acronym
- CoSMAP
- Status last verified
- Jun 2026
- First submitted
- 3 Jun 2026
- Last updated
- 17 Sep 2026
- 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 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Perioperative and Postoperative Outcomes of Single-port (SP) Extraperitoneal Approach and Multi-port (MP) Transperitoneal Approach in Robot-assisted Radical Prostatectomy：A Propensity Score-matched Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT07666217
- Acronym / sponsor ID
- CoSMAP / ISI-DV5-URO-J01(CoSMAP)
- Conditions
- Prostate Cancer
- Keywords
- Robot assisted radical prostatectomy, RARP, Single port, da Vinci SP, Extraperitoneal approach, Transperitoneal approach, Propensity score matching
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 625 participants (estimated)
- Lead sponsor
- Intuitive SurgicalIndustry (pharma, biotech, devices)
- Study start
- 26 Mar 2026 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 24 Jun 2026 (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 multicenter retrospective observational study aims to compare perioperative and postoperative outcomes between the da Vinci SP extraperitoneal approach (SP-EA) and the robotic multi-port transperitoneal approach (MP-TA) in robot-assisted radical prostatectomy for localized prostate cancer.
Detailed description
This is a multicenter, retrospective, propensity score-matched observational cohort study conducted in Japan.
The study aims to compare perioperative and postoperative outcomes of robot-assisted radical prostatectomy (RARP) performed using the da Vinci SP extraperitoneal approach (SP-EA) and the robotic multi-port transperitoneal approach (MP-TA) in patients with localized prostate cancer.
Clinical data will be retrospectively and continuously collected from participating institutions and analyzed to evaluate the utility and potential clinical benefits of the SP-EA approach.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SP-EA group | – | –Patients who underwent robot assisted radical prostatectomy using the da Vinci SP extraperitoneal approach. |
| MP-TA group | – | –Patients who underwent robot assisted radical prostatectomy using the robotic multi port transperitoneal approach. |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with localized prostate cancer who underwent robot assisted radical prostatectomy using either the da Vinci SP extraperitoneal approach or the robotic multi port transperitoneal approach at participating institutions in Japan.
Key inclusion criteria (3 listed)
- Patients with localized prostate cancer (clinical stage T1-T3a, N0, M0) eligible for radical prostatectomy
- Patients who underwent RARP via SP-EA or MP-TA on or after January 1, 2023
- Patients with available postoperative follow-up data for ≥6 months (≥166 days) *note 1)
Key exclusion criteria (5 listed)
- Patients who have expressed an intention to refuse the use of their data for this study
- Patients who underwent RARP using surgical approaches other than those specified in the inclusion criteria (e.g., transvesical approach)
- Patients who underwent RARP with pelvic lymph node dissection (PLND)
- Patients with a history of radiotherapy for prostate cancer
- Any other patients whom the principal investigator or a co-investigator deem inappropriate, such as those with missing outcome data.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of postoperative complications and Clavien-Dindo Grade 3a or higher postoperative complications
Time frame: Within 6 and 12 months after surgery
Postoperative complications occurring after robot assisted radical prostatectomy, including complications classified as Clavien-Dindo Grade 3a or higher.
Urinary continence rate
Time frame: Within 6 and 12 months after surgery
Achievement of urinary continence after robot assisted radical prostatectomy.
16 secondary outcomes
Total operative time
Time frame: During surgery
Console time
Time frame: During surgery
Estimated blood loss
Time frame: During surgery
Intraoperative transfusion rate
Time frame: During surgery
Nerve sparing rate
Time frame: During surgery
Drain placement rate
Time frame: During surgery
Intraoperative complication rate
Time frame: During surgery
Conversion rate
Time frame: During surgery
Positive surgical margin rate
Time frame: Immediately after surgery
Length of hospital stay
Time frame: From the date of surgery until the date of hospital discharge, assessed up to 30 days after surgery
Foley catheter duration
Time frame: From the date of surgery until the date of Foley catheter removal, assessed up to 30 days after surgery
Postoperative serum PSA level
Time frame: At 1, 3, 6 and 12 months after surgery
Biochemical recurrence rate
Time frame: Within 6 and 12 months after surgery
Readmission rate
Time frame: Within 6 and 12 months after surgery
Numeric Rating Scale (NRS) pain score
Time frame: At hospital discharge, an average of 7 days
Sexual function score
Time frame: At 6 months and 12 months after surgery
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 17 Sep 2026.
- 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.
Masashi Takenaka principal investigator
Fujita Health University
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by Intuitive Surgical at 8 sites in Japan.
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 3 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Japan. 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?
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of postoperative complications and Clavien-Dindo Grade 3a or higher postoperative complications (time frame: Within 6 and 12 months after surgery). The study lists 2 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 17 Sep 2026.