Modified Radical Prostatectomy for Prostate Cancer

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether removing lymph nodes (small glands that are part of the immune system) during prostate cancer surgery benefits patients when scans don't show cancer in those nodes. The trial aims to determine if this surgical step, known as a lymph node template, improves outcomes for prostate cancer patients. Participants will be divided into groups: some will have lymph nodes removed, while others will not, to compare results. Ideal candidates are those scheduled for prostate cancer surgery at MSKCC and have no suspicious lymph nodes on scans. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that removing lymph nodes during prostate cancer surgery is generally safe and helps doctors identify cancerous lymph nodes. Studies have found that this procedure does not increase the risk of complications compared to omitting it. Most patients tolerate the surgery well, with few reports of serious side effects.

These findings come from large studies, providing strong evidence. However, as with any surgery, some risks exist, such as infection or bleeding, though these are uncommon. Discussing any concerns with a doctor before joining a trial is advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the techniques being explored in the Modified Radical Prostatectomy trial for prostate cancer because they aim to refine surgical procedures and potentially improve outcomes. One of the key features under investigation is the use of a hemostatic agent, which might reduce bleeding during surgery, enhancing safety and recovery. Additionally, the trial is comparing different lymph node removal strategies, which could optimize the balance between effective cancer control and minimizing surgical impact. By exploring these variations, the trial hopes to identify methods that could lead to better post-operative results and quality of life for patients.

What evidence suggests that this trial's treatments could be effective for prostate cancer?

Research has shown that removing lymph nodes during prostate surgery might benefit some patients. In this trial, participants will be assigned to different treatment arms: one with lymphadenectomy and another without. Some studies suggest that lymph node removal, especially in high-risk cancer cases, can improve cancer outcomes. For instance, one study found that patients with high-risk prostate cancer had better early results when more lymph nodes were removed. However, other research has indicated that lymph node removal does not always improve survival rates. Thus, the benefit of removing lymph nodes can vary depending on the individual patient's situation. Overall, more research is needed to determine when lymph node removal is most beneficial. ^{5 6 7 8 9}

Who Is on the Research Team?

Andrew Vickers, PhD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S2287888224000539

Comparison of oncological outcomes between extended ... A total of 585 patients underwent ePLND and 404 did not. A median of 19 lymph nodes was removed in the ePLND cohort. After propensity score matching, no ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12038081/

Impact of Pelvic Lymph Node Dissection on Early Oncological ... During follow‐up, a total of 4 patients (1.6%) died, all due to non‐cancer‐related causes. Overall, OS rates of PLND‐RP and RP‐only groups were ...

3. auajournals.org auajournals.org/doi/10.1097/JU.0000000000004587

Pelvic Lymph Node Dissection in Prostate Cancer In line with our findings, several authors published data indicating improved oncological outcomes in patients with limited LN metastasis who ...

4. nature.com nature.com/articles/s41598-025-00926-2

Reevaluating the therapeutic role of extended lymph node ... Morizane, S. et al. Extent of pelvic lymph node dissection improves early oncological outcomes for patients with high-risk prostate cancer ...

5. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.5_suppl.390

Evaluating the efficacy and safety of pelvic lymph node ... Pooled outcome data showed that PLND after radical prostatectomy did not independently predict BRFS (HR: 1.22; 95%CI: 0.99-1.50; p=0.006), MFS ( ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9987045/

Different lymph node dissection ranges during radical ... The extension of the lymph node dissection range is believed to improve the lymph node-positive rate and reduce the risk of metastases [26]. All the included ...

7. ascopubs.org ascopubs.org/doi/abs/10.1200/JCO.2025.43.5_suppl.149

Safety and efficacy of salvage lymph node dissection in ... Salvage Lymph node dissection (sLND) has been described in retrospective trials as effective with biochemical response in up to 60% of patients ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10296518/

Oncologic Outcomes of Lymph Node Dissection at Salvage ... Lymph node invasion represents a poor prognostic factor after primary radical prostatectomy for prostate cancer.

9. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0302283824026472

Pelvic Lymph Node Dissection in Prostate Cancer We conducted a clinically integrated randomized trial comparing limited versus extended pelvic LND (PLND) during radical prostatectomy and previously reported ...