AzTrials
AzTrials

Stage I Prostate CancerNCT02079155

Robotic Athermal Nerve-Sparing Radical Prostatectomy

A study testing robot-assisted laparoscopic surgery, laboratory biomarker analysis and quality-of-life assessment in people with Stage I Prostate Cancer and Stage IIA Prostate Cancer, run by Case Comprehensive Cancer Center.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 35 to 72 years, men only
What is being tested?
robot-assisted laparoscopic surgery, laboratory biomarker analysis and quality-of-life assessment
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
Jun 2012to Jan 2016
Phase
Interventional
Are there results?
None posted in the registry

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 35 to 72 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

About this study

Official title: Prospective Single-Center Randomized Study of Robotic Athermal Nerve-Sparing Radical Prostatectomy: Laparoendoscopic Single-Site Versus Standard Approach

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.

Read the detailed description

PRIMARY OBJECTIVES:

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

SECONDARY OBJECTIVES:

  1. 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.

  1. 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.

  1. 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.

Being tested
robot-assisted laparoscopic surgery, laboratory biomarker analysis, quality-of-life assessment, questionnaire administration
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • robot-assisted laparoscopic surgeryProcedure or surgery

    Undergo RALP

  • robot-assisted laparoscopic surgeryProcedure or surgery

    Undergo R-LESS RP

  • laboratory biomarker analysisOther

    Correlative studies

  • quality-of-life assessmentOther

    Also called quality of life assessment

    Ancillary studies

  • questionnaire administrationOther

    Ancillary studies

Study groups in NCT02079155
Study groupRoleWhat they receive
Arm I (RALP)Active comparatorPatients undergo standard RALP.
Receives: Procedure: robot-assisted laparoscopic surgery; Other: laboratory biomarker analysis; Other: quality-of-life assessment; Other: questionnaire administration
Arm II (R-LESS RP)ExperimentalPatients undergo R-LESS RP.
Receives: Procedure: robot-assisted laparoscopic surgery; Other: laboratory biomarker analysis; Other: quality-of-life assessment; Other: questionnaire administration

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean pain score, evaluated with the visual analog pain score (VAPS)

    Compared using the Mann-Whitney U test as appropriate.

    Measured: Up to 1 year

  2. Mean analgesic consumption, obtained from medical charts and reported as units of parenteral morphine equivalents (mg)

    Compared using the Mann-Whitney U test as appropriate.

    Measured: Up to 1 month

Secondary outcomes (14)

  1. Time to oral intake

    Compared using the Mann-Whitney U test as appropriate.

    Measured: Up to 1 year

  2. Time to resume ambulation

    Compared using the Mann-Whitney U test as appropriate.

    Measured: Up to 1 year

  3. Length of hospital stay, counted in whole days from the day of surgery to the day of discharge

    Compared using the Mann-Whitney U test as appropriate.

    Measured: Up to 3 days

  4. Operative time, defined as time elapsed from skin incision to placement of the final skin suture

    Compared using the Mann-Whitney U test as appropriate.

    Measured: Day 1

  5. Estimated blood loss during surgery

    Compared using the Mann-Whitney U test as appropriate.

    Measured: Day 1

  6. Additional ports during surgery

    Compared using the Mann-Whitney U test as appropriate.

    Measured: Day 1

  7. Incidence of conversion to standard RALP, laparoscopic, or open surgery in R-LESS RP patients

    Compared by means of Fisher's exact test.

    Measured: Day 1

  8. Incidence of intraoperative complications

    Compared using the Mann-Whitney U test as appropriate.

    Measured: Day 1

  9. Incidence of postoperative complications, recorded according to the Clavien classification

    Compared using the Mann-Whitney U test as appropriate.

    Measured: Up to 1 year

  10. Body image perception, measured using the BIQ

    Compared using the Mann-Whitney U test as appropriate. The BIQ consists of two scales: the body image scale, which assesses attitudes to bodily appearance and consists of five questions (score 5-20), and the cosmetic scale which assesses degree of satisfaction with the appearance of the scare and consists of three questions (score 3-24).

    Measured: Up to 1 year

  11. Scar evaluation, assessed using the Patient and Observer Scar Assessment Scale

    Compared using the Mann-Whitney U test as appropriate. Assessed at suture removal and at 6 months. The Patient and Observer Scar Assessment Scale consists of two scales: the observer scale and the patient scale. Both scales contain 6 items that are scored numerically. Each of the six items on both scales has a 10-step score, with 10 indicating the worst imaginable scar or sensation. The total score of both scales consists of adding the scores of each of the six items (range, 6 to 60). The lowest score, 6, reflects normal skin, whereas the highest score, 60, reflects the worst imaginable scar.

    Measured: Up to 1 year

  12. Health related quality of life, measured as patients' perception of functioning, disability, and well-being

    Compared using the Mann-Whitney U test as appropriate. Patients' perception of functioning, disability, and well-being will be measured related to the following eight concepts: physical functioning, role limitations cause by physical health problems, bodily pain, general health, vitality, social functioning, role limitation caused by emotional problems, and mental health.

    Measured: Up to 1 year

  13. Urinary continence, assessed by the number of pads used daily

    Compared using the Mann-Whitney U test as appropriate. Evaluated at 1, 3, 6, and 12 months after the procedure.

    Measured: Up to 12 months

  14. Erectile function, assessed by the IIEF-5

    Compared using the Mann-Whitney U test as appropriate. Evaluated once in preoperative period and at 1, 3, 6, and 12 months after the procedure.

    Measured: Up to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Mar 2014 (estimated)
  2. Study startJun 2012
  3. Primary completionJan 2016
  4. Study completionJan 2016

Why it stopped: Research Cancelled

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02079155
Sponsor's protocol ID
CASE12811
Other IDs
NCI-2014-00393, CASE12811, P30CA043703
Status last verified
Jan 2016
First submitted
3 Mar 2014
Last updated
22 Jan 2016
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing robot-assisted laparoscopic surgery, laboratory biomarker analysis and quality-of-life assessment in people with Stage I Prostate Cancer and Stage IIA Prostate Cancer, run by Case Comprehensive Cancer Center.

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 8 inclusion and 8 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: withdrawn, as of the sponsor's last update on 22 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.

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?

The study was withdrawn before enrolling participants, so there are no results.

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?

Mean pain score, evaluated with the visual analog pain score (VAPS) (time frame: Up to 1 year). 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?

On the ClinicalTrials.gov record for NCT02079155.

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 22 Jan 2016.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in