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Trial of Modifications to Radical Prostatectomy

StatusActive, Not Recruiting
PhasePhase 3
Started2011-07
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 11 months later Jul 2026 → Jul 2027
See other at-risk trials from Memorial Sloan Kettering Cancer Center

Amendment history

2026-08-13
Study Status v41
Primary completion pushed: 2026-07 → 2027-07
Completion pushed: 2026-07 → 2027-07
2025-08-13
Study Status v40
Primary completion date2025-07→2026-07
Completion date2025-07→2026-07
2024-08-12
Recruiting→Active, Not Recruiting Study Status, Study Design, Contacts/Locations v39
Trial statusRecruiting→Active, Not Recruiting
Enrollment targetestimated 2600→confirmed 3204
Study sitesdetails revised at 5 of 5 sites
2024-01-19
Study Status v38
Re-verified, no change to tracked fields
2023-11-13
Study Status, Eligibility v37
Eligibility criteria+33 characters
[...] ive/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 c [...]
Show 36 earlier versions
2023-10-31
Study Status, Contacts/Locations v36
Study sites3→5
2023-08-28
Study Status v35
Primary completion date2023-07→2025-07
Completion date2023-07→2025-07
2023-05-09
2 amendments v33-v34
2 re-verifications since 2023-03-14, no change to tracked fields
2022-11-08
Study Status, Arms and Interventions, Eligibility v32
Study arms3→4
InterventionsLymph node template (Procedure), Transverse versus vertical closure (Procedure), antibiotic prophylaxis (Drug)→Hemostatic Agent (Drug), Lymph node template (Procedure), Transverse versus vertical closure (Procedure), antibiotic prophylaxis (Drug)
Eligibility criteria+278 characters
[...] rostate 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 Pr [...] prior pelvic radiation therapy used to treat prostate cancer Hemostatic agent vs. no hemostatic agent No additional exclusion criteria
2022-03-07
Study Status, Study Description, Arms and Interventions v31
Re-verified, no change to tracked fields
2021-09-27
Study Status, Arms and Interventions, Eligibility v30
Eligibility criteria-273 characters
[...] rostate cancer with one of the consenting surgeons at MSKCC Port site closure technique: Patients 21 years or older scheduled for minimally-invasive radical prostatectomy for the treatment of prostate cancer with one of the consenting surgeons at MSKCC. Exclusion Criteria: Lymphadenectomy vs no lymphadenectomy Presence of positive/suspicious pelvic nodes on MRI, CT or CTPSMA scan (positive/suspicious defined as a pelvic node >15mm in shor [...] prior pelvic radiation therapy used to treat prostate cancer Port site closure technique: There are no exclusion criteria for any of the modifications
2021-09-21
2 amendments v28-v29
2 re-verifications since 2021-07-07, no change to tracked fields
2021-06-23
Study Status v27
Primary completion date2021-07→2023-07
Completion date2021-07→2023-07
2020-06-23
Study Status, Eligibility v26
Eligibility criteria-223 characters
[...] . Exclusion Criteria: Lymphadenectomy vs no lymphadenectomy Presence of distant metastatic disease on conventional imaging studies (computed tomography (CT) of the abdomen and pelvis and 99mTc-methylene diphosphonate bone scan. NaF PET/CT scan cannot be a substitute for a bone scan Presence of positive/suspicious pelvic nodes on MRI or CT (positive/suspicious defined as a pelvic node >10mm15mm in short axis or a node with abnormal morphology such as ro [...]
2020-05-27
Study Status, Eligibility v25
Eligibility criteria+413 characters
Inclusion Criteria: Patients do not have to be eligible for both modifications to be included in the study. TemplateLymphadenectomy modificationvs no lymphadenectomy: Patients 21 years or older scheduled for radical prostatectomy for the treatment of prostate cancer with one of the consenting surgeons at MSKCC. Antbiotic prophylaxis: Patients 21 years or older scheduled for radical prostatectomy for the treatment of prostate cancer with one of the consenting surgeons at MSKCC. Port site closure technique: Patients 21 years or older sche [...] ne of the consenting surgeons at MSKCC. Exclusion Criteria [...]
2020-02-24
Study Status, Contacts/Locations v24
Study sitescontacts updated at 3 of 3 sites
2019-10-22
2 amendments v22-v23
2 re-verifications since 2019-07-22, no change to tracked fields
2019-05-06
Study Status, Study Design v21
Enrollment target2300→2600
2018-11-27
Study Status v20
Re-verified, no change to tracked fields
2017-11-27
Study Status, Contacts/Locations v19
Study sitesdetails revised at 1 of 3 sites
2017-03-08
Study Status v18
Re-verified, no change to tracked fields
2017-01-03
Study Status, Contacts/Locations v17
Study sites3 entries, revised
Memorial Sloan Kettering West HarrisonWestchester
2016-07-11
Study Status, Study Design v16
Enrollment target1400→2300
2016-06-21
2 amendments v14-v15
2 re-verifications since 2015-12-21, no change to tracked fields
2015-11-03
Study Status, Study Description, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v13
Study sites2→3
Study arms2→3
InterventionsFascial suturing (Procedure), Lymph node template (Procedure)→Lymph node template (Procedure), Transverse versus vertical closure (Procedure), antibiotic prophylaxis (Drug)
Eligibility criteria+173 characters
Inclusion Criteria: Patients do not have to be eligible for both modifications to be included in the study. Fascial suturing: Template modification: Patients 21 years or older scheduled [...] ostate cancer with one of the consenting surgeons at MSKCC. Antbiotic prophylaxis: ⇅ moved Patients 21 years or older scheduled for radical prostatectomy for the treatment of prostate cancer with one of the consenting surgeons at MSKCC. Port site closure technique: Patients 21 years or older scheduled for minimally-invasive radical prostatectomy for the treatment of prostate cancer with one of the consenting surgeons a [...] [...]
Secondary endpoints1 to 2 entries
urinary tract infection (UTI)
Primary endpoints1 entry, revised
ToPatient-reported compare the impact of anastomotic suturing with and without inclusion of the fascia on continence outcomeshernia
2015-08-18
Study Status v12
Re-verified, no change to tracked fields
2015-02-16
Study Status, Contacts/Locations, References v11
Study sites2 entries, revised
Memorial Sloan- Kettering Cancer Center at Basking Ridge Memorial Sloan- Kettering Cancer Center
2014-08-13
6 amendments v5-v10
6 re-verifications since 2012-09-06, no change to tracked fields
2012-06-14
Study Status, Eligibility v4
Eligibility criteria-150 characters
[...] ostate cancer with one of the consenting surgeons at MSKCC. Risk of positive lymph nodes 2% or greater as assessed by the most current version of the MSKCC risk prediction tool (available at www.nomograms.org) Exclusion Criteria: Fascial suturing: No exclusion criteria. Template modification: No exclusion criteria.
2012-03-07
Study Status, Contacts/Locations v3
Study sitescontacts updated at 1 of 2 sites
2012-02-08
Study Status, Sponsor/Collaborators v2
Re-verified, no change to tracked fields
2011-08-08
Study Status, Eligibility v1
2011-07-29
Original filing
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."
Trial Details
NCT Number NCT01407263
Lead Sponsor Memorial Sloan Kettering Cancer Center
Conditions Prostate Cancer
Enrollment 3,204 participants
Start Date 2011-07
Primary Completion 2027-07 (estimated)
Study Completion 2027-07 (estimated)
Updated on ClinicalTrials.gov 2026-08-17