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NCT Number: NCT07666217

CoSMAP Trial: SP-EA vs MP-TA Robot-Assisted Radical Prostatectomy

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Sex eligibility

Male

Study type

Observational

Primary location

Ichinomiyanishi Hospital, Ichinomiya, Aichi-ken, Japan

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. 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.

  2. Urinary continence rate

    Time frame: Within 6 and 12 months after surgery

    Achievement of urinary continence after robot assisted radical prostatectomy.

Secondary outcomes

  1. Total operative time

    Time frame: During surgery

    Total operative time measured in minutes.

  2. Console time

    Time frame: During surgery

    Console time measured in minutes.

  3. Estimated blood loss

    Time frame: During surgery

    Estimated blood loss measured in milliliters.

  4. Intraoperative transfusion rate

    Time frame: During surgery

    Proportion of patients requiring blood transfusion during surgery.

  5. Nerve sparing rate

    Time frame: During surgery

    Proportion of patients undergoing nerve sparing procedures.

  6. Drain placement rate

    Time frame: During surgery

    Proportion of patients requiring surgical drain placement.

  7. Intraoperative complication rate

    Time frame: During surgery

    vascular injury / organ injury / nerve injury / others

  8. Conversion rate

    Time frame: During surgery

    Conversion to open surgery

  9. Positive surgical margin rate

    Time frame: Immediately after surgery

    Proportion of patients with positive surgical margins

  10. Length of hospital stay

    Time frame: From the date of surgery until the date of hospital discharge, assessed up to 30 days after surgery

    Number of days from the date of surgery (Day 0) to hospital discharge.

  11. Foley catheter duration

    Time frame: From the date of surgery until the date of Foley catheter removal, assessed up to 30 days after surgery

    Number of days from the date of surgery (Day 0) to Foley catheter removal.

  12. Postoperative serum PSA level

    Time frame: At 1, 3, 6 and 12 months after surgery

    Postoperative serum prostate-specific antigen (PSA) level measured as an actual value in ng/mL

  13. Biochemical recurrence rate

    Time frame: Within 6 and 12 months after surgery

    Defined as PSA ≥ 0.2 ng/mL

  14. Readmission rate

    Time frame: Within 6 and 12 months after surgery

  15. Numeric Rating Scale (NRS) pain score

    Time frame: At hospital discharge, an average of 7 days

    Numeric Rating Scale (NRS) ranging from 0 to 10, with higher scores indicating worse pain.

  16. Sexual function score

    Time frame: At 6 months and 12 months after surgery

    Sexual Health Inventory for Men (SHIM), ranging from 1 to 25, with higher scores indicating better erectile function

Sponsors and collaborators

Lead sponsor

Intuitive Surgical

Industry

Registry information

Official study 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

Acronym: CoSMAP

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Jun 24, 2026
Registry last updated
Jun 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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