Modified Radical Prostatectomy for Prostate Cancer

Recruiting at 4 trial locations

Overseen By Behfar Ehdaie, MD, PhD

Age: 18+

Sex: Male

Trial Phase: Phase 3

Sponsor: Memorial Sloan Kettering Cancer Center

Disqualifiers: Positive pelvic nodes, Prior pelvic radiation

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

3204 Participants Needed

Trial Summary

What is the purpose of this trial?

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."

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Lymph node template in the clinical trial Modified Radical Prostatectomy for Prostate Cancer?

Research suggests that the extent of pelvic lymph node dissection (removal of lymph nodes) during surgery can impact long-term cancer outcomes in men with prostate cancer, indicating that a more thorough removal may be beneficial. ^{1 2 3 4 5}

Is modified radical prostatectomy with pelvic lymph node dissection safe for humans?

The research articles focus on the practice and outcomes of radical prostatectomy with pelvic lymph node dissection for prostate cancer, but they do not provide specific safety data. However, this procedure is a standard treatment for high-risk prostate cancer, suggesting it is generally considered safe when performed by experienced surgeons. ^{2 6 7 8 9}

How does the lymph node template treatment differ from other prostate cancer treatments?

The lymph node template treatment during a modified radical prostatectomy for prostate cancer involves a specific approach to removing lymph nodes, which can be either limited or extended. This method is unique because it focuses on the diagnostic and therapeutic benefits of lymph node dissection, potentially impacting cancer-specific survival by addressing the burden of positive nodes rather than just the number of nodes removed. ^{1 10 11 12 13}

Research Team

Andrew Vickers, PhD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

This trial is for men aged 21 or older with prostate cancer who are scheduled for radical prostatectomy at MSKCC. It's open to those without positive lymph nodes on scans and no prior pelvic radiation therapy. The study includes patients regardless of whether they're eligible for both surgical modifications being tested.

Inclusion Criteria

I am 21 or older and scheduled for a specific prostate cancer surgery at MSKC.

I am 21 or older and scheduled for prostate cancer surgery at MSKCC.

You don't have to meet both requirements to participate in the study.

Exclusion Criteria

I have had a scan showing abnormal pelvic nodes or received pelvic radiation for prostate cancer.

I am not excluded by my choice of hemostatic agent use.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery

Participants undergo radical prostatectomy with or without lymph node dissection

1 day

Post-operative Monitoring

Participants are monitored for urinary tract infection within 10 days of catheter removal

10 days

Follow-up

Participants are monitored for patient-reported hernia and biochemical recurrence

2 years

Treatment Details

Interventions

• Lymph node template

Trial Overview The trial is testing the effects of different surgical techniques during radical prostatectomy, including lymph node dissection versus none, and the use of a hemostatic agent to control bleeding. Patients will be randomly assigned to receive one technique or not.

Participant Groups

Group I: Transverse versus vertical closure of the port site incision (Closed as of 9/30/2021) Experimental Treatment 1 Intervention

Group II: One vs. three days of antibiotic prophylaxis (Closed as of 9/30/2021) Experimental Treatment 1 Intervention

Group III: Lymphadenectomy vs. no lymphadenectomy Experimental Treatment 1 Intervention

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.

Group IV: Hemostatic agent vs. no hemostatic agent Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

Pathological features of lymph node metastasis for predicting biochemical recurrence after radical prostatectomy for prostate cancer. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Association between surgeon and hospital characteristics and lymph node counts from radical prostatectomy and pelvic lymph node dissection. [2015]

3. Germany pubmed.ncbi.nlm.nih.gov

Acceptance and efficacy of recommended adjuvant radiotherapy in patients with positive lymph nodes at radical prostatectomy: a preference-based study. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Rise in Node-Positive Prostate Cancer Incidence in Context of Evolving Use and Extent of Pelvic Lymphadenectomy. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Anatomic extent of pelvic lymph node dissection: impact on long-term cancer-specific outcomes in men with positive lymph nodes at time of radical prostatectomy. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Adherence to pelvic lymph node dissection recommendations according to the National Comprehensive Cancer Network pelvic lymph node dissection guideline and the D'Amico lymph node invasion risk stratification. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

Radical Prostatectomy Without Pelvic Lymph Node Dissection Is Widely Practiced in High-Risk Patients Despite Poorer Survival. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Perioperative and oncological outcomes of radical prostatectomy for high-risk prostate cancer in the UK: an analysis of surgeon-reported data. [2020]

9. England pubmed.ncbi.nlm.nih.gov

Applied anatomy of pelvic lymph nodes and its clinical significance for prostate cancer:a single-center cadaveric study. [2021]

10. Australia pubmed.ncbi.nlm.nih.gov

Clinical significance of limited and extended pelvic lymph node dissection during robot-assisted radical prostatectomy for patients with localized prostate cancer: A retrospective, propensity score matching analysis. [2023]

11. Japan pubmed.ncbi.nlm.nih.gov

Positive node burden rather than the number of removed nodes impacts survival in patients with node-positive prostate cancer. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

The Predictive Value of Preoperative Negative Prostate Specific Membrane Antigen Positron Emission Tomography Imaging for Lymph Node Metastatic Prostate Cancer. [2021]

13. United States pubmed.ncbi.nlm.nih.gov

Pelvic lymph node dissection for prostate cancer: frequency and distribution of nodal metastases in a contemporary radical prostatectomy series. [2012]