Minimally invasive surgery for early-stage testicular seminoma

Robotic Retroperitoneal Lymph Node Dissection (R-RPLND) as First-line Treatment for Clinical Stage IIA/B Testicular Seminoma

This study is testing a new, less invasive robotic surgery for early-stage testicular seminoma to see if it can safely help patients avoid chemotherapy and radiation while improving their quality of life.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 25 (estimated)
• Ages: 18 Years and up
• Sex: Male
• Sponsor: University Health Network, Toronto (Academic / other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 1 site (Toronto, Ontario)
• Trial ID: NCT05345158 on ClinicalTrials.gov

What this trial studies

This study investigates the safety and efficacy of robotic retroperitoneal lymph node dissection (R-RPLND) as the first-line treatment for patients with stage IIA/B testicular seminoma. The approach aims to provide a less invasive alternative to traditional chemotherapy, radiation therapy, and open surgery. The primary endpoint is relapse-free survival at 2 and 5 years, while secondary endpoints include complications, quality of life, and the ability to avoid chemotherapy and radiation. Approximately 25 patients will be enrolled and followed for at least 5 years to gather comprehensive data on outcomes.

Who should consider this trial

Good fit: Ideal candidates are patients with histologically confirmed stage IIA/B seminomatous testicular germ cell tumors and specific lymphadenopathy criteria.

Not a fit: Patients with advanced disease or those not meeting the inclusion criteria will not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could reduce the need for chemotherapy and radiation, minimizing side effects and improving quality of life for patients.

How similar studies have performed: While robotic approaches in surgery are gaining traction, this specific application for stage IIA/B seminoma is relatively novel and has not been extensively tested in prior studies.

Eligibility criteria

Inclusion Criteria:

* Histologically confirmed seminomatous testicular germ cell tumour with negative margins on radical orchiectomy
* Lymphadenopathy in the retroperitoneum: at least one lymph node ≤5cm in size (in the transverse plane) detected on contrast CT scan or MRI (CS IIA/B; or active surveillance relapse with CS IIA/B equivalent)
* CT Chest negative for metastasis
* Patients qualify for this trial under the following scenarios: (1) initial diagnosis of clinical or stage IIA/B disease or (2) recurrence after surveillance for clinical stage I disease
* Patients with serum tumour marker elevation are eligible if the elevated marker does not exceed the following cut-offs within 10 days of RPLND: AFP (\< 2.5 x ULN) and β-hCG (\<5 IU/L)
* Curative treatment with RPLND is intended
* Under the care of a uro-oncologist at Princess Margaret Cancer Centre
* Willing to comply with follow-up protocol
* Capable of providing informed consent

Exclusion Criteria:

* Retroperitoneal lymphadenopathy \>5cm in the transverse plane (CS IIC)
* Metastasis to distant lymph nodes or any organ (CS III)
* History of chemotherapy or radiotherapy to the retroperitoneum
* Patients with previous scrotal or retroperitoneal surgery for indication other than germ cell tumour
* Patients in reduced general condition, with uncontrolled intercurrent illnesses, or with life-threatening disease
* Patients with psychiatric illnesses that would limit compliance with study requirements
* Unsuitable for robotic surgery (determined by treating physician)

Where this trial is running

Toronto, Ontario

• Princess Margaret Cancer Centre — Toronto, Ontario, Canada (Recruiting)

Study contacts

• Principal investigator: Robert Hamilton, MD — The Princess Margaret Cancer Foundation
• Study coordinator: Robert Hamilton, MD

Conditions Lymphadenopathy Retroperitoneal; Stage II Testicular Seminoma