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Prostate CancerPhase 3NCT01407263

Trial of Modifications to Radical Prostatectomy

A Phase 3 study testing Lymph node template, Transverse versus vertical closure and antibiotic prophylaxis in people with Prostate Cancer, run by Memorial Sloan Kettering Cancer Center at 5 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 21 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
Lymph node template, Transverse versus vertical closure and antibiotic prophylaxis
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3,204 participants
Where
5 sitesUnited States
Study dates
Jul 2011to Jul 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

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 21 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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 on CT or MRI, a PSMA avid node, 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

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • Memorial Sloan Kettering Cancer Center at Basking Ridge

    Basking Ridge, New Jersey, 07920

  • Memorial Sloan Kettering Westchester

    Harrison, New York, 10604

  • Memorial Sloan Kettering Bergen (Consent Only)

    Montvale, New Jersey, 07645

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • Memorial Sloan Kettering Cancer Center @ Nassau (Consent only)

    Uniondale, New York, 11553

Other trials in United States

About this study

Official title: A Randomized Trial of Modifications to Radical Prostatectomy

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."

Conditions
Prostate Cancer
Being tested
Lymph node template, Transverse versus vertical closure, antibiotic prophylaxis, Hemostatic Agent
Keywords
radical prostatectomy, anastomotic suturing, lymph node dissection, 11-096
Medical subject headings
Prostatic Neoplasms

What participants receive

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

  • Lymph node templateProcedure or surgery

    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.

  • Transverse versus vertical closureProcedure or surgery

    Transverse versus vertical closure of the port site incision

  • antibiotic prophylaxisDrug

    One vs. three days of antibiotic prophylaxis at catheter removal

  • Hemostatic AgentDrug

    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 groups in NCT01407263
Study groupRoleWhat they receive
Lymphadenectomy vs. no lymphadenectomyExperimentalIn 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.
Receives: Procedure: Lymph node template
Transverse versus vertical closure of the port site incision (Closed as of 9/30/2021)ExperimentalNot described
Receives: Procedure: Transverse versus vertical closure
One vs. three days of antibiotic prophylaxis (Closed as of 9/30/2021)ExperimentalNot described
Receives: Drug: antibiotic prophylaxis
Hemostatic agent vs. no hemostatic agentExperimentalNot described
Receives: Drug: Hemostatic Agent

What is being measured

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

  1. Patient-reported hernia

    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.

    Measured: 1 year

Secondary outcomes (2)

  1. To evaluate whether a modification to the template for lymph node dissection reduces biochemical recurrence rates

    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.

    Measured: 2 years

  2. urinary tract infection (UTI)

    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.

    Measured: within 10 days

Timeline

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

  1. First posted2 Aug 2011 (estimated)
  2. Study startJul 2011
  3. Primary completionJul 2027 (estimated)
  4. Study completionJul 2027 (estimated)

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
Masking
None (open label)
Enrolment
3,204 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01407263
Sponsor's protocol ID
11-096
Status last verified
Aug 2026
First submitted
29 Jul 2011
Last updated
17 Aug 2026
Results posted
No

Publications

  • Touijer KA, Vertosick EA, Sjoberg DD, Liso N, Nalavenkata S, Melao B, Laudone VP, Ehdaie B, Carver B, Eastham JA, Scardino PT, Vickers AJ. Pelvic Lymph Node Dissection in Prostate Cancer: Update from a Randomized Clinical Trial of Limited Versus Extended Dissection. Eur Urol. 2025 Feb;87(2):253-260. doi: 10.1016/j.eururo.2024.10.006. Epub 2024 Oct 29.

    PubMed 39472200

  • Gaffney CD, Vertosick EA, Laudone V, Goh AC, Carlsson SV, Pietzak E, Donahue T, Smith R, Touijer K, Vickers AJ, Ehdaie B. Randomized Trial of Transverse vs Vertical Extraction Site Incision After Robotic Radical Prostatectomy. J Urol. 2024 Sep;212(3):401-408. doi: 10.1097/JU.0000000000004066. Epub 2024 Aug 8.

    PubMed 39115122

  • 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.

    PubMed 33865797

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Lymph node template, Transverse versus vertical closure and antibiotic prophylaxis in people with Prostate Cancer, run by Memorial Sloan Kettering Cancer Center at 5 sites in United States.

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 5 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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?

Patient-reported hernia (time frame: 1 year). 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 NCT01407263, which also lists 3 linked publications.

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 17 Aug 2026.

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