An interventional study of Robotic Retroperitoneal Lymph Node Dissection (RPLND) in Lymphadenopathy Retroperitoneal and Stage II Testicular Seminoma, sponsored by University Health Network, Toronto. Recruiting at 1 site in Canada. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-19.
Sponsored by University Health Network, Toronto · Not applicable, Interventional, and Treatment
This study will investigate the safety and efficacy of using robotic retroperitoneal lymph node dissection (R-RPLND), a minimally invasive surgical approach, as the first-line of treatment for stage IIA/B (or equivalent) seminoma patients. R-RPLND will be trialed as an alternative to chemotherapy, radiation therapy (for seminoma patients) and open RPLND in this study.
Typical treatment for testicular cancer that has spread to the retroperitoneum is chemotherapy, radiation therapy, or surgery. Chemotherapy and radiation therapy have numerous side effects and long-term complications and open retroperitoneum lymph node dissection (RPLND), the typical surgical approach for advanced testicular cancer, can be invasive and is fairly morbid. This study will investigate the safety and efficacy of using robotic retroperitoneal lymph node dissection (R-RPLND), a minimally invasive surgical approach, as the first-line of treatment for stage IIA/B (or equivalent) seminoma patients. R-RPLND will be trialed as an alternative to chemotherapy, radiation therapy (for seminoma patients) and open RPLND in this study. The primary endpoint of this study is Relapse Free Survival (RFS) at 2 years and 5 years. Secondary endpoints of this study include characteristics of relapse, time to progression, percentage of patients that can avoid chemotherapy and radiation therapy after R-RPLND, perioperative, short-term and long-term complications, rate of retrograde ejaculation, time to return of ejaculation and return to work. Additionally, Quality of Life will be measured by a questionnaire administered at 4 months post-RPLND. Approximately 25 patients will be enrolled in this study and will be followed for at least 5 years.
The data will provide important insights into the safety and efficacy of performing R-RPLND for seminoma patients with stage IIA/B (or equivalent) disease. This information will be paramount to informing clinical practice and patterns of care for treating advanced seminoma and use of the robotic approach for RPLND.
63 studies on the registry are indexed under Seminoma; 15 are open to participants now.
This study's planned enrollment of 25 is below the median of 50 across 47 interventional studies indexed under Seminoma.
Browse Seminoma studies →University Health Network, Toronto is the lead sponsor of 1,438 studies on the registry; 297 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 3 (18%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Robotic retroperitoneal lymph node dissection performed using the DaVinci robotic surgical system.
Procedure: Robotic Retroperitoneal Lymph Node Dissection (RPLND)
Robotic RPLND performed using the DaVinci robotic surgical system.
Relapse Free Survival (RFS)
RFS is defined as the length of time between date of R-RPLND and 1) relapse or 2) death from any cause with censoring of patients lost to follow-up.
Time frame: 2 years after RPLND
Relapse Free Survival (RFS)
RFS is defined as the length of time between date of R-RPLND and 1) relapse or 2) death from any cause with censoring of patients lost to follow-up.
Time frame: 5 years after RPLND
Rate of relapse
Defined as the proportion of participants experiencing relapse after primary R-RPLND. Relapse is defined as a new mass meeting size criteria (\>1cm) with or without elevation of serum tumour markers.
Time frame: Study duration (5 years)
Time to progression (TTP)
TTP is defined as the time elapsed between date of R-RPLND and disease progression.
Time frame: Study duration (5 years)
Relapse in vs. out of surgical field
Relapse is classified as in vs. out of R-RPLND surgical field.
Time frame: Study duration (5 years)
Relapse tumour characteristics
Tumour size (in cm) and location
Time frame: Study duration (5 years)
Mode of relapse detection
Mode of relapse detection (e.g., CT, serum tumour markers, physical exam, etc.).
Time frame: Study duration (5 years)
Treatment burden
Number and type of treatment modalities
Time frame: Study duration (5 years)
IGCCCG risk classification
International Germ Cell Cancer Collaborative Group (IGCCCG) risk classification
Time frame: Study duration (5 years)
Cancer-specific survival (CSS)
Defined as the length of time from date of R-RPLND to the date of death from disease.
Time frame: Study duration (5 years)
Overall survival (OS)
Defined as the length of time from the date of R-RPLND until death due to any cause.
Time frame: Study duration (5 years)
Percentage of patients that are able to avoid adjuvant treatment
Percentage of patients, after treatment with R-RPLND, that are able to avoid chemotherapy and radiotherapy.
Time frame: Study duration (5 years)
Complications
Perioperative, short-term (≤30 days) and long-term (\>30 days) complications. Scored using the Clavien Dindo classification system and assessed as attributable to R-RPLND by physician.
Time frame: Study duration (5 years)
Quality of Life Surveys for Cancer Patients
Measured using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for cancer patients (EORTC QLQ-C30).
Time frame: 4 months post-operatively
Quality of Life Surveys for Testicular Cancer Patients
Measured using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for testicular cancer patients (EORTC QLQ-TC26).
Time frame: 4 months post-operatively
Return to work
Self-reported by the patient and queried at each study visit until return to work.
Time frame: Study duration (5 years)
Rate of ejaculation
Self-reported by the patient and queried at each study visit until ejaculation returns.
Time frame: Study duration (5 years)
Time of return of ejaculation
Defined as the duration of time between R-RPLND and study visit when patient self-reports return of ejaculatory function.
Time frame: Study duration (5 years)
Operative time
Operative time (minutes) for surgical metrics.
Time frame: Duration of surgery (an average of 8 hours)
Estimated blood loss
Estimated blood loss (mL) for surgical metrics.
Time frame: Duration of surgery (an average of 8 hours)
Transfusion rate
Transfusion rate (mL) for surgical metrics.
Time frame: Duration of surgery (an average of 8 hours)
Type of hemostatic agents
Type of hemostatic agents used during surgery for surgical metrics.
Time frame: Duration of surgery (an average of 8 hours)
Number of hemostatic agents
Number of hemostatic agents used during surgery for surgical metrics.
Time frame: Duration of surgery (an average of 8 hours)
Conversion rate to open surgery
Conversion rate to open surgery for surgical metrics.
Time frame: Duration of surgery (an average of 8 hours)
Number of lymph nodes resected
Number of lymph nodes resected
Time frame: Duration of surgery (an average of 8 hours)
Length of stay
Length of stay (in days) from the date of admission to date of discharge.
Time frame: Post-operatively (an average of 2 days)
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