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Trial of Modifications to Radical Prostatectomy

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ClinicalTrials.gov Identifier: NCT01407263
Recruitment Status : Recruiting
First Posted : August 2, 2011
Last Update Posted : November 10, 2022
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Tracking Information
First Submitted Date  ICMJE July 29, 2011
First Posted Date  ICMJE August 2, 2011
Last Update Posted Date November 10, 2022
Study Start Date  ICMJE July 2011
Estimated Primary Completion Date July 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 3, 2015)
Patient-reported hernia [ Time Frame: 1 year ]
Patient-reported hernia is a routine assessment on post-operative questionnaires completed by prostate cancer patients at MSKCC. The questionnaire asks about hernia near the surgical scar and if there has been a need for surgical repair of the hernia.
Original Primary Outcome Measures  ICMJE
 (submitted: July 29, 2011)
To compare the impact of anastomotic suturing with and without inclusion of the fascia on continence outcomes [ Time Frame: 1 year ]
Continence outcomes will be taken from patient-reported outcomes questionnaires; however, if a patient-reported outcome is not available, then physician-reported outcomes will be used. Continence is defined as a binary endpoint of no pad use at one year.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 3, 2015)
  • To evaluate whether a modification to the template for lymph node dissection reduces biochemical recurrence rates [ Time Frame: 2 years ]
    Biochemical recurrence is defined as any postoperative PSA of 0.2 ng / mL or higher, or treatment with hormones, radiotherapy or chemotherapy starting six months or more after radical prostatectomy.
  • urinary tract infection (UTI) [ Time Frame: within 10 days ]
    urinary tract infection (UTI) within 10 days of catheter removal. We will use the CDC's definition of UTI: symptomatic UTI diagnosed in patients with positive urine cultures (≥100,000 microorganisms per cm3) and at least one of the following signs or symptoms with no other recognized cause: fever (>38oC), urgency, frequency, dysuria or suprapubic tenderness.50 UTI is routinely captured by clinical staff as a surgical complication.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 29, 2011)
To evaluate whether a modification to the template for lymph node dissection reduces biochemical recurrence rates [ Time Frame: 2 years ]
Biochemical recurrence is defined as any postoperative PSA of 0.2 ng / mL or higher, or treatment with hormones, radiotherapy or chemotherapy starting six months or more after radical prostatectomy.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Trial of Modifications to Radical Prostatectomy
Official Title  ICMJE A Randomized Trial of Modifications to Radical Prostatectomy
Brief Summary This trial will evaluate whether the following aspect of surgical technique influence outcome: Lymph node dissection. In some patients, scans taken before surgery show that a lymph node has cancer. Surgeons make sure to remove those affect lymph nodes and all other lymph nodes in the area. However, it is not known whether removing lymph nodes helps prostate cancer patients whose scans do not show positive nodes. In this study, patients with clear scans will either receive a lymph node dissection or not."
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Prostate Cancer
Intervention  ICMJE
  • Procedure: Lymph node template
    Inclusion of the external iliac, hypogastric and obturator fossa nodal groups in the template undergoing a Radical Prostatectomy. Modifying the template for lymph node dissection may lead to removal of additional affected nodes, reducing the chance of recurrence. .No lymph nodes will be removed in patients randomized to the no PLND arm.
  • Procedure: Transverse versus vertical closure
    Transverse versus vertical closure of the port site incision
  • Drug: antibiotic prophylaxis
    One vs. three days of antibiotic prophylaxis at catheter removal
  • Drug: Hemostatic Agent
    For the patients randomized to routine indwelling HA agent use, the operating surgeon may choose to use either Surgicel™, Surgicel SNoW™, Arista™, FloSeal or surgeon's choice HA directed at the prostatic fossa, ligated dorsal vein complex, or neurovascular bundles. Because there is no standard HA or method of application, the surgeon will apply the HA according to the surgeon's experience and document both the HA used, and the location applied in the operative report. For patients randomized to no routine indwelling HA use, surgeons will only apply a HA if they are unable to achieve hemostasis using traditional means or feel it would be unsafe to complete the operation without using a HA for additional hemostasis. Providers in either arm may use HA as needed provided the intention is not to leave the HA indwelling.
Study Arms  ICMJE
  • Experimental: Lymphadenectomy vs. no lymphadenectomy
    In patients randomized to standard, only the nodal packet under the external iliac vein and above the obturator nerve will be dissected. For patients randomized to the modified template, the external iliac, hypogastric and obturator fossa nodal groups will be removed.No lymph nodes will be removed in patients randomized to the no PLND arm.
    Intervention: Procedure: Lymph node template
  • Experimental: Transverse versus vertical closure of the port site incision (Closed as of 9/30/2021)
    Intervention: Procedure: Transverse versus vertical closure
  • Experimental: One vs. three days of antibiotic prophylaxis (Closed as of 9/30/2021)
    Intervention: Drug: antibiotic prophylaxis
  • Experimental: Hemostatic agent vs. no hemostatic agent
    Intervention: Drug: Hemostatic Agent
Publications * Touijer KA, Sjoberg DD, Benfante N, Laudone VP, Ehdaie B, Eastham JA, Scardino PT, Vickers A. Limited versus Extended Pelvic Lymph Node Dissection for Prostate Cancer: A Randomized Clinical Trial. Eur Urol Oncol. 2021 Aug;4(4):532-539. doi: 10.1016/j.euo.2021.03.006. Epub 2021 Apr 15.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 6, 2019)
2600
Original Estimated Enrollment  ICMJE
 (submitted: July 29, 2011)
1400
Estimated Study Completion Date  ICMJE July 2023
Estimated Primary Completion Date July 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients do not have to be eligible for both modifications to be included in the study.

Lymphadenectomy vs no lymphadenectomy:

  • Patients 21 years or older scheduled for radical prostatectomy for treatment of prostate cancer with one of the consenting surgeons at MSKCC

Hemostatic agent vs. no hemostatic agent

  • Patients 21 years or older scheduled for minimally invasive radical prostatectomy for the treatment of prostate cancer with one of the consenting surgeons at MSKC

Exclusion Criteria:

Lymphadenectomy vs no lymphadenectomy

  • Presence of positive/suspicious pelvic nodes on MRI, CT or PSMA scan (positive/suspicious defined as a pelvic node >15mm in short axis or a node with abnormal morphology such as roundness or irregularity or loss of fatty hilum
  • Any prior pelvic radiation therapy used to treat prostate cancer

Hemostatic agent vs. no hemostatic agent

  • No additional exclusion criteria
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Andrew Vickers, PhD 646-888-8233
Contact: Peter Scardino, MD 646-422-4329
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01407263
Other Study ID Numbers  ICMJE 11-096
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Memorial Sloan Kettering Cancer Center
Original Responsible Party Andrew Vickers, PhD, Memorial Sloan-Kettering Cancer Center
Current Study Sponsor  ICMJE Memorial Sloan Kettering Cancer Center
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Andrew Vickers, PhD Memorial Sloan Kettering Cancer Center
PRS Account Memorial Sloan Kettering Cancer Center
Verification Date March 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP