Clinical trial NCT02079155: Robotic Athermal Nerve-Sparing Radical Prostatectomy
Official title: Prospective Single-Center Randomized Study of Robotic Athermal Nerve-Sparing Radical Prostatectomy: Laparoendoscopic Single-Site Versus Standard Approach
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Stage I Prostate Cancer
Stage IIA Prostate Cancer
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2014-03-05
Enrollment: 0
Sex: MALE
Minimum age (years): 35
Maximum age (years): 72
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This randomized clinical trial compares a recently developed technique, called robotic laparoendoscopic single-site radical prostatectomy (R-LESS RP), to the current standard of robotic technique for prostate cancer, robot-assisted laparoscopic prostatectomy (RALP) in treating patients with newly diagnosed, locally confined prostate cancer. Both procedures are types of robotic radical prostatectomy, or the robot-assisted removal of the prostate though a small incision in the belly. In the standard approach, 4-5 small (1-2 cm) incisions are made in the lower abdomen to allow the insertion of robotic instruments. In the R-LESS technique, all instruments are inserted through a single incision. R-LESS RP is less invasive than RALP and may leave a smaller scar and cause less pain.

Detailed description: PRIMARY OBJECTIVES:

I. To evaluate pain and analgesic requirement of R-LESS RP compared to standard RALP.

SECONDARY OBJECTIVES:

I. Time to oral intake. II. Time to resume ambulation. III. Hospital stay, counted in whole days from the day of surgery to the day of discharge.

IV. Perioperative parameters, including: operative time (defined as time elapsed from skin incision to placement of the final skin suture); estimated blood loss; additional ports; conversion to standard RALP (in R-LESS RP patients), or laparoscopic, or open surgery; length of stay.

V. Intraoperative complications. VI. Postoperative complications, recorded according to the Clavien classification.

VII. Body image perception, measured using the body image questionnaire (BIQ). VIII. Scar evaluation (at suture removal and at 6 month) by using a validated assessment tool, the Patient and Observer Scar Assessment Scale.

IX. Health related quality of life, measured as patients' perception of functioning, disability, and well-being related to the following eight concepts: physical functioning, role limitations caused by physical health problems, bodily pain, general health, vitality, social functioning, role limitation caused by emotional problems, and mental health.

X. Urinary continence, assessing the number of pads used daily. XI. Erectile Function, assessed by the International Index of Erectile Function (IIEF-5).

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients undergo standard RALP.

ARM II: Patients undergo R-LESS RP.

After completion of study treatment, patients are followed up periodically for 1 year.

Eligibility criteria: Inclusion Criteria:

* Patients must have a biopsy proven newly diagnosed locally confined, stage T1a, T2a or T2b prostate cancer
* Judged by the study doctor to be a suitable candidate for a radical prostatectomy
* Serum prostate specific antigen equal to or less than 10 ng/mL
* Gleason score equal to or less than 7
* Life expectancy greater than 10 years
* Prostate size on trans-rectal ultrasound (TRUS) measurement less than 50 grams
* Favorable operative risk defined as American Society of Anesthesiology Score (ASA score) =\< 3
* 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

Exclusion Criteria:

* Patients with any prior pelvic surgery
* Patients with prior history of pelvic fractures or hip replacement
* Large pelvic or intra-abdominal masses
* 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)
* Poor surgical risk (defined as American Society of Anesthesiology Score \> 3)
* Active infection
* Uncorrected coagulopathy
* Body mass index equal to or greater than 35

Primary outcomes:
measure: Mean pain score, evaluated with the visual analog pain score (VAPS)
timeFrame: Up to 1 year
measure: Mean analgesic consumption, obtained from medical charts and reported as units of parenteral morphine equivalents (mg)
timeFrame: Up to 1 month
Secondary outcomes:
measure: Time to oral intake
timeFrame: Up to 1 year
measure: Time to resume ambulation
timeFrame: Up to 1 year
measure: Length of hospital stay, counted in whole days from the day of surgery to the day of discharge
timeFrame: Up to 3 days
measure: Operative time, defined as time elapsed from skin incision to placement of the final skin suture
timeFrame: Day 1
measure: Estimated blood loss during surgery
timeFrame: Day 1
measure: Additional ports during surgery
timeFrame: Day 1
measure: Incidence of conversion to standard RALP, laparoscopic, or open surgery in R-LESS RP patients
timeFrame: Day 1
measure: Incidence of intraoperative complications
timeFrame: Day 1
measure: Incidence of postoperative complications, recorded according to the Clavien classification
timeFrame: Up to 1 year
measure: Body image perception, measured using the BIQ
timeFrame: Up to 1 year
measure: Scar evaluation, assessed using the Patient and Observer Scar Assessment Scale
timeFrame: Up to 1 year
measure: Health related quality of life, measured as patients' perception of functioning, disability, and well-being
timeFrame: Up to 1 year
measure: Urinary continence, assessed by the number of pads used daily
timeFrame: Up to 12 months
measure: Erectile function, assessed by the IIEF-5
timeFrame: Up to 12 months
Other outcomes:
Locations:
Study officials:
affiliation: Case Comprehensive Cancer Center
name: Jihad Kaouk
role: PRINCIPAL_INVESTIGATOR
References: