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Single-Port Versus Multi-Port Robotic Radical Prostatectomy for the Treatment of Prostate Cancer

Trial Status: Approved

This phase III trial compares the effect of single-port versus multi-port robotic radical prostatectomy in treating patients with prostate cancer. Single-port robotic radical prostatectomy is a surgery during which a single incision is made. Multi-port robotic radical prostatectomy is a surgery during which six small incisions are made. This study aims to understand whether a single incision surgery ends up with better recovery after surgery.

Inclusion Criteria

  • Subjects must have histologically or cytologically confirmed prostate cancer, stage T1a, T2a or T2b prostate cancer using magnetic resonance (MRI) staging
  • Life expectancy greater than 10 years
  • Age > 18 years
  • Subjects must have ability to understand and the willingness to sign a written informed consent document or have a surrogate with the ability to understand and the willingness to sign a written informed consent for radical prostatectomy

Exclusion Criteria

  • Patients with any prior extensive pelvic surgery or pelvic fractures
  • Prior treatment for prostate cancer such as radiotherapy or focal therapy
  • Uncorrected coagulopathy
  • Active soft tissue or urinary infection
  • Poor surgical risk (defined as American Society of Anesthesiology score > 3)
  • Any condition or history of illness or surgery that, in the opinion of the investigator, might confound the results of the study or pose additional risk to the patient (e.g. significant cardiovascular conditions that significantly affect the life expectancy, chronic opiate use, pain syndrome, or drug abuse
  • Subjects with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

Ohio

Cleveland
Case Comprehensive Cancer Center
Status: APPROVED
Contact: Jihad Kaouk
Phone: 216-444-2976

PRIMARY OBJECTIVE:

I. To evaluate hospital stay, counted in hours from the time of transfer to the post anesthesia care unit (PACU) to discharge.

SECONDARY OBJECTIVES:

I. Perioperative parameters, including operative time (defined as the time elapsed from skin incision to placement of the final skin suture); estimated blood loss; additional ports; conversion to multi-port (MP) robotic surgery (for single-port [SP] procedures), or standard laparoscopic surgery, or open surgery.

II. Intraoperative complication comparison.

III. Intraoperative Trendelenburg position requirement for the patient.

IV. Intraoperative peritoneum breach rate as defined by intraoperative pneumoperitoneum after insufflation of extraperitoneal space.

V. Pain and analgesic requirement of SP surgery compared to MP surgery.

VI. Pain intensity will be evaluated with a visual analog pain scale, a validated instrument.

VII. Analgesic requirements will be obtained from medical charts and reported as units of parenteral morphine equivalents (mg).

VIII. Time to solid and liquid oral intake.

IX. Postoperative complications recorded according to the Clavien- Dindo classification.

X. Body image perception.

XI. Scar evaluation (at postoperative visit and after 6 months) by using a validated assessment tool, the Patient and Observer Scar Assessment Scale.

XII. Urinary continence, assessing the number of pads used daily.

XIII. Erectile function assessed by the International Index of Erectile Function (IIEF-5) scale.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients undergo robotic radical prostatectomy with the multi-port approach involving 5 or 6 incisions approximately 1 cm in size each.

ARM II : Patients undergo robotic radical prostatectomy with the single-port approach involving 1 incision approximately 3 cm in size.

After completion of study treatment, patients are followed up at 7 days, 1, 3, 6, and 1 year.

Trial Phase Phase III

Trial Type Treatment

Lead Organization
Case Comprehensive Cancer Center

Principal Investigator
Jihad Kaouk

  • Primary ID CASE7820
  • Secondary IDs NCI-2021-02255
  • Clinicaltrials.gov ID NCT04696263