Robotic Athermal Nerve-Sparing Radical Prostatectomy

NCT ID: NCT02079155

Last Updated: 2016-01-22

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2016-01-31

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.

Conditions

Stage I Prostate Cancer; Stage IIA Prostate Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Arm I (RALP)

Patients undergo standard RALP.

Group Type: ACTIVE_COMPARATOR

robot-assisted laparoscopic surgery

Intervention Type: PROCEDURE

Undergo RALP

laboratory biomarker analysis

Intervention Type: OTHER

Correlative studies

quality-of-life assessment

Intervention Type: OTHER

Ancillary studies

questionnaire administration

Intervention Type: OTHER

Ancillary studies

Arm II (R-LESS RP)

Patients undergo R-LESS RP.

Group Type: EXPERIMENTAL

robot-assisted laparoscopic surgery

Intervention Type: PROCEDURE

Undergo R-LESS RP

laboratory biomarker analysis

Intervention Type: OTHER

Correlative studies

quality-of-life assessment

Intervention Type: OTHER

Ancillary studies

questionnaire administration

Intervention Type: OTHER

Ancillary studies

Interventions

robot-assisted laparoscopic surgery

Undergo RALP

Intervention Type: PROCEDURE

robot-assisted laparoscopic surgery

Undergo R-LESS RP

Intervention Type: PROCEDURE

laboratory biomarker analysis

Correlative studies

Intervention Type: OTHER

quality-of-life assessment

Ancillary studies

Intervention Type: OTHER

questionnaire administration

Ancillary studies

Intervention Type: OTHER

Other Intervention Names

quality of life assessment

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

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 72 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Case Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jihad Kaouk

Role: PRINCIPAL_INVESTIGATOR

Case Comprehensive Cancer Center

Other Identifiers

NCI-2014-00393

Identifier Type: REGISTRY

Identifier Source: secondary_id

CASE12811

Identifier Type: OTHER

Identifier Source: secondary_id

P30CA043703

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CASE12811

Identifier Type: -

Identifier Source: org_study_id