Robotic Surgery for Testicular Seminoma

Overseen By Robert Hamilton, MD

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: University Health Network, Toronto

Disqualifiers: Metastasis, Previous chemotherapy, Psychiatric illnesses, others

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

Compensation: Varies

Number of Visits: 1

Duration: Surgery duration (an average of 8 hours)

25 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new, less invasive surgery using robotic technology to treat seminoma, a type of testicular cancer. The goal is to determine if this surgery, known as Robotic Retroperitoneal Lymph Node Dissection (RPLND), serves as a safe and effective first treatment, instead of traditional methods like chemotherapy or open surgery. Suitable participants have a confirmed seminoma with specific lymph node involvement, have not undergone chemotherapy or radiation for it, and are under the care of a specific cancer center. The trial aims to offer a new option that could lead to quicker recovery and fewer side effects. As an unphased trial, it provides patients the opportunity to explore innovative surgical options that may improve recovery times and reduce side effects.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that robotic retroperitoneal lymph node dissection is safe for seminoma patients?

Research has shown that robotic retroperitoneal lymph node dissection (R-RPLND) is generally well-tolerated by patients. In studies involving this procedure for testicular cancer, the results were promising. One study found R-RPLND to be safe and effective for medium-term cancer treatment. Another study compared robotic surgery to traditional open surgery and found R-RPLND to be safe.

In terms of numbers, one study showed that out of 6,673 patients treated for testicular cancer, a small group underwent robotic surgery. Despite the smaller group size, the outcomes remained positive. These results suggest a good safety profile for this robotic approach.

Overall, these findings provide confidence in the safety of R-RPLND for testicular cancer patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Robotic Retroperitoneal Lymph Node Dissection (RPLND) is unique because it uses the DaVinci robotic surgical system to perform precise and minimally invasive surgery. Unlike traditional open surgery options for treating testicular seminoma, this robotic method aims to reduce recovery time, minimize scarring, and decrease the likelihood of complications. Researchers are excited about this approach because it could offer patients a quicker return to normal activities and improve overall quality of life after surgery.

What evidence suggests that robotic retroperitoneal lymph node dissection is effective for testicular seminoma?

Research has shown that using robots for retroperitoneal lymph node dissection (R-RPLND) holds promise for treating testicular cancer. Studies on non-seminomatous testicular cancer have found that R-RPLND safely and effectively removes cancerous lymph nodes. For example, one study found that patients achieved good cancer control with this method. Another study compared robotic surgery to traditional open surgery and suggested that robotic methods might be equally safe and effective. Although most research has focused on non-seminomatous cancer, these findings offer hope that the robotic method could also work for seminoma, which this trial specifically evaluates. ^{1 3 4 6 7}

Who Is on the Research Team?

Robert Hamilton, MD

Principal Investigator

The Princess Margaret Cancer Foundation

Are You a Good Fit for This Trial?

This trial is for men with a specific type of testicular cancer (seminoma) that has spread to nearby lymph nodes but not beyond. They must have had surgery to remove the tumor, no metastasis in the chest, and meet certain criteria regarding tumor markers. It's not for those who've had extensive previous treatments or surgeries, other serious illnesses, or are unsuitable for robotic surgery.

Inclusion Criteria

Willing to comply with follow-up protocol

I have a lymph node in my abdomen that is 5cm or smaller, confirmed by a scan.

I am planning to undergo surgery to remove lymph nodes for cancer treatment.

Exclusion Criteria

My doctor says I can't have surgery using a robot.

I have large lymph nodes in my abdomen.

I have had chemotherapy or radiotherapy targeting the area behind my stomach.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo robotic retroperitoneal lymph node dissection (R-RPLND) using the DaVinci robotic surgical system

Surgery duration (an average of 8 hours)

1 visit (in-person)

Post-operative Recovery

Participants recover from surgery and are monitored for immediate post-operative complications

2 days

Inpatient stay

Follow-up

Participants are monitored for safety, effectiveness, and quality of life after treatment

5 years

Regular follow-up visits

What Are the Treatments Tested in This Trial?

Interventions

• Robotic Retroperitoneal Lymph Node Dissection (RPLND)

Trial Overview The study tests a minimally invasive surgical technique called Robotic Retroperitoneal Lymph Node Dissection (R-RPLND) as an initial treatment option instead of chemotherapy or radiation. The goal is to see if this approach is safe and effective for stage IIA/B seminoma patients.

How Is the Trial Designed?

Group I: Robotic Retroperitoneal Lymph Node Dissection Experimental Treatment 1 Intervention

Robotic retroperitoneal lymph node dissection performed using the DaVinci robotic surgical system.

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+

Published Research Related to This Trial

Robot-assisted retroperitoneal lymph node dissection (RARPLND) for stage I-IIB testicular cancer showed no retroperitoneal recurrence over an average follow-up of 21.2 months, indicating effective treatment outcomes.

RARPLND demonstrated similar results to laparoscopic techniques and better perioperative outcomes compared to open surgery, with a low complication rate of 8%, suggesting it is a safe and effective option for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Robot-Assisted Retroperitoneal Lymphadenectomy in Testicular Cancer Treatment: A Systematic Review. Tselos, A., Moris, D., Tsilimigras, DI., et al.[2019]

Robotic-assisted retroperitoneal lymph node dissection (RA-RPLND) is associated with shorter hospital stays, less blood loss, and fewer overall complications compared to traditional open surgery, based on a systematic review of 7 studies with 862 patients.

While RA-RPLND shows better lymph node yields than laparoscopic methods, it has similar outcomes in terms of operation time, lymph node positivity rates, and postoperative complications, indicating its safety and efficacy for treating testicular cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of robotic retroperitoneal lymph node dissection in testicular cancer: a systematic review and meta-analysis. Ge, S., Zeng, Z., Li, Y., et al.[2023]

Robotic-assisted retroperitoneal lymph node dissection (R-RPLND) is a promising surgical option for testicular cancer that shows less morbidity compared to traditional open RPLND, making it a safer choice for patients.

R-RPLND has been effectively used not only for early-stage testicular cancer but also for low-volume, clinical stage II disease, offering benefits such as shorter hospital stays and reduced blood loss while maintaining low complication rates and effective cancer control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Robotic-assisted retroperitoneal lymph node dissection for testicular cancer. Gereta, S., Hung, M., Hu, JC.[2023]

In a study comparing robotic retroperitoneal lymph node dissection (R-RPLND) and laparoscopic RPLND (L-RPLND) in 37 patients with stage I testicular cancer, both techniques showed similar safety profiles and perioperative outcomes, including operative time and complication rates.

The findings suggest that R-RPLND is comparable to L-RPLND, but it is still uncertain whether R-RPLND provides any additional benefits over the traditional laparoscopic approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comparative analysis of robotic vs laparoscopic retroperitoneal lymph node dissection for testicular cancer. Harris, KT., Gorin, MA., Ball, MW., et al.[2022]

Robot-assisted retroperitoneal lymph node dissection (R-RPLND) shows acceptable safety and feasibility, with major complication rates of 4.1% for primary cases and 8.5% for post-chemotherapy cases, based on a systematic review of 4222 patients.

R-RPLND is associated with significantly lower transfusion rates (0.9% vs 14.5%) and fewer overall complications (7.8% vs 18.5%) compared to open RPLND (O-RPLND), although there is a notable conversion rate to open surgery in post-chemotherapy cases (9.0%).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Robot-assisted retroperitoneal lymph node dissection: a systematic review of perioperative outcomes. Garg, H., Mansour, AM., Psutka, SP., et al.[2023]

Robotic retroperitoneal lymph node dissection (RPLND) is emerging as a promising alternative to traditional open RPLND for testicular cancer, aiming to reduce surgery-related complications while maintaining similar effectiveness in cancer treatment.

Current evidence suggests that robotic RPLND can effectively stage and treat testicular cancer, although more extensive studies with longer follow-up are needed to fully confirm its oncologic efficacy compared to open surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Indications, evolving technique, and early outcomes with robotic retroperitoneal lymph node dissection. Werntz, RP., Pearce, SM., Eggener, SE.[2019]

Robotic-assisted laparoscopic retroperitoneal lymph node dissection (R-RPLND) is an effective treatment option for high-risk, clinical stage I testicular cancer, showing similar complication rates to traditional open RPLND but with benefits like shorter hospital stays and less blood loss.

As R-RPLND becomes more common in high-volume medical centers, further research, including head-to-head trials against open RPLND, will be necessary to fully understand its long-term effectiveness in treating testicular cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Robotic retroperitoneal lymph node dissection for testicular cancer: feasibility and latest outcomes. Mittakanti, HR., Porter, JR.[2020]

The PRIMETEST trial evaluated primary retroperitoneal lymph node dissection (RPLND) as an alternative to chemotherapy or radiation for patients with clinical stage IIA/B seminoma, but it did not meet its primary endpoint of less than 30% recurrence, with a recurrence rate of 30% after a median follow-up of 32 months.

Despite not meeting the primary goal, the trial suggests that RPLND may still be beneficial for carefully selected patients, as it achieved a progression-free survival rate of 70%, indicating potential for avoiding the side effects of conventional treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase 2 Single-arm Trial of Primary Retroperitoneal Lymph Node Dissection in Patients with Seminomatous Testicular Germ Cell Tumors with Clinical Stage IIA/B (PRIMETEST). Hiester, A., Che, Y., Lusch, A., et al.[2023]

Robotic-assisted laparoscopic retroperitoneal lymph node dissection (R-RPLND) shows promising early outcomes for treating clinical stage I nonseminomatous germ cell tumors, offering similar recovery benefits as traditional laparoscopic methods while enhancing surgical precision and visualization.

Despite its advantages, further large-scale studies are necessary to confirm R-RPLND's efficacy and safety before it can replace the open approach as the standard treatment for low-stage testicular cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Review of Outcomes and Technique for the Robotic-Assisted Laparoscopic Retroperitoneal Lymph Node Dissection for Testicular Cancer. Schwen, ZR., Gupta, M., Pierorazio, PM.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8185654/

Outcomes and expanding indications for robotic ... Safety and early oncologic effectiveness of primary robotic retroperitoneal lymph node dissection for nonseminomatous germ cell testicular cancer. Eur Urol ...

2. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/ijc.35486

The perioperative outcomes of retroperitoneal lymph node ... Overall, 6673 patients underwent RPLND for testicular cancer. Of them, 5570 (83%) received open, 819 (12%) laparoscopic, and 284 (5%) robot- ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/27234998/

Safety and Early Oncologic Effectiveness of Primary ... We examined outcomes after robot-assisted retroperitoneal lymph node dissection for patients with low-stage nonseminomatous testicular cancer

4. sciencedirect.com sciencedirect.com/science/article/pii/S2214388225000554

Robot-assisted post-chemotherapy retroperitoneal lymph ... This study summarizes the experience with lateral and supine approaches in robot-assisted PC-RPLND for metastatic non-seminomatous germ cell tumors.

5. mdpi.com mdpi.com/2072-6694/17/9/1439

Feasibility and Oncological Safety of Robotic ... This study aimed to compare the safety and oncological outcomes of open (O-RPLND) and robotic (R-RPLND) retroperitoneal lymph node dissection for testicular ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2405456924002414

Testis Cancer Oncological Outcomes Following Robotic ... Robotic PC-RPLND in testicular cancer is associated with acceptable intermediate-term oncological outcomes in appropriately selected patients.

7. pure.johnshopkins.edu pure.johnshopkins.edu/en/publications/safety-and-early-oncologic-effectiveness-of-primary-robotic-retro

Safety and Early Oncologic Effectiveness of Primary ... Patient summary: We examined outcomes after robot-assisted retroperitoneal lymph node dissection for patients with low-stage nonseminomatous testicular cancer ...