NCT06932458 A Clinical Trial of Primary Retroperitoneal Lymph Node Dissection in Patients With Testicular Seminoma With Limited Retroperitoneal Metastases
| NCT ID | NCT06932458 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Western University, Canada |
| Condition | Testicular Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2025-07-17 |
| Primary Completion | 2028-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 30 participants in total. It began in 2025-07-17 with a primary completion date of 2028-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Testicular cancer represents 1% of adult neoplasms and is the most common solid malignancy in young men. At diagnosis, approximately 90% of cases are germ cell tumours (GCT), categorised as either seminoma (55-60%) or non-seminoma types (40-45%). For many years, the management of patients with CS IIA/B seminoma and retroperitoneal lymph node involvement ≤ 3 cm are eligible for treatment with either radiotherapy or chemotherapy Despite high cure rates for CS II seminoma (approximately 90%) with chemotherapy or radiotherapy, concerns persist regarding short and long-term treatment-related toxicities (such as increased risks of cardiovascular disease and secondary malignancies As such, an alternative strategy which has been explored in this study is the role of RPLND for the management of these patients
Eligibility Criteria
Inclusion Criteria: 1. Adult patients (\>18 years) with pure seminoma on radical orchiectomy specimen. 2. Initial CS I presentation with subsequent retroperitoneal relapse on surveillance, or de novo CS II at presentation. 3. Axial imaging of lymphadenopathy within 8 weeks of the date of RPLND 1. No more than 2 enlarged retroperitoneal lymph nodes, each no more than 3cm in the primary landing zones. 2. Suitable for proposed bilateral RPLND template 4. Serum tumour markers (alpha-fetoprotein (AFP), human chorionic gonadotropin (HCG), and lactate dehydrogenase (LDH)) must all be within normal limits within 2 weeks of planned RPLND Exclusion Criteria: 1. Any condition deemed by the treating surgeon to pose an unacceptable risk for retroperitoneal lymph node dissection 2. Any non-seminoma component on the orchiectomy specimen. 3. AFP \>20 at any time point, pre- or post-orchiectomy.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06932458 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Testicular Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06932458 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06932458 currently recruiting?
Yes, NCT06932458 is actively recruiting participants. Contact the research team at Kaydee.Connors@lhsc.on.ca for enrollment information.
Where is the NCT06932458 trial being conducted?
This trial is being conducted at London, Canada.
Who is sponsoring the NCT06932458 clinical trial?
NCT06932458 is sponsored by Western University, Canada. The trial plans to enroll 30 participants.
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