NCT07498959

Primary RPLND Versus Systemic Chemotherapy in Good-prognosis Metastatic Testicular Cancer

Testicular Cancer Treatment: Assessing Quality of Life in Good Prognosis Metastastic Disease

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: Sahlgrenska University Hospital · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this prospective observational study is to learn about the short- and long-term effects of treating men over the age of 18 with good prognosis metastatic testicular cancer with either primary retropertioneal lymph node dissection, RPLND, (for low-stage metastastic seminoma) or three doses of chemotherapy for metastastic seminoma or nonseminoma. The main question it aims to answer is: Does primary RPLND lower the risk of side-effects compared to receiving chemotherapy?

Detailed description

The current SWENOTECA guidelines from 2020 state that patients with seminoma stage IIA-IIB with \<3 lymph nodes \<30 mm in any dimension should be recommended a primary RPLND rather than the previously considered standard treatment, chemotherapy. The rationale behind this change is to reduce the number of patients at risk of acute and long-term side effects from chemotherapy. We aim to perform a quality-of-life assessment to determine whether the change from chemotherapy to surgery is justified regarding short- and long-term (2 years) quality-of-life. Two study groups are formed: 1. Surgery group consisting of patients scheduled for a primary RPLND due to a CS IIa/b seminoma (maximum 2 nodes, maximum 30 mm in any diameter) 2. Chemotherapy group (control group) of patients receiving 3 doses of BEP due to a good prognosis seminoma or nonseminoma. Patients will be recrutied at eight study centers in Sweden and Norway. Since RPLND is centralized in Sweden and Norway, the study will be population-based. Primary outcome is: 1. Changes across study-groups in global HRQOL after treatment as measured by the EORTC QLQ-C30 with the testicular cancer-specific supplement EORTC QLQ-TC26. Secondary outcomes are: 2. Differences in fatigue across study-groups as measured by the Fatigue Questionnaire (FQ). 3. Differences across study-groups in patient-reported prevalence of retrograde ejaculation as assessed by supplementary questions. 4. Rate of doctor-reported complications related to treatment in the study-groups. 5. Differences in quality-adjusted life years across study-groups as measured by the EQ-5D-5L tool 6. PFS in both study-groups (longer follow-up than 2 years permitted) Data will be assessed at baseline, at 3 months after start of treatment, at 6 months, 1 year and 2 years.

Conditions

• Testicular Cancer
• Seminoma
• Quality of Life
• De-escalation
• RPLND

Interventions

Type	Name	Description
PROCEDURE	primary RPLND for low-stage metasatatic seminoma	surgical lymph node dissection
DRUG	3 courses of chemotherapy; Blemocin, Etoposide and Platinum (BEP)	systemic tretament for good prognosis metastastic testicular cancer

Timeline

• Start date: 2026-03-19
• Primary completion: 2031-03-25
• Completion: 2032-03-25
• First posted: 2026-03-27
• Last updated: 2026-03-27

Locations

1 site across 1 country: Sweden