PRIMETEST II – trial to test new predictors of recurrence in CS II A/B seminoma patients treated with primary robot-assisted retroperitoneal lymph node dissectio

Phase 2

Recruiting

• Conditions: C62; Malignant neoplasm of testis

• Registration Number: DRKS00031749
• Lead Sponsor: niversitätsklinikum Düsseldorf

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-09-12
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Male
• Target Recruitment: 60

Inclusion Criteria

Histologically verified seminomatous testicular germ cell tumour
- and an iliac or retroperitoneal lymph node metastasis detected on contrast CT or MRI, which is classified as local or unilateral regionally.
- maximum extension of the lymph node metastasis (LK-M) singular or multiple with a maximum size of 5 cm in transverse CT diameter (UICC IIB)

Exclusion Criteria

- LK-M with a transverse diameter >5 cm in the C (UICC IIC)
- Metastases other than LK-M (UICC III)
- The patient has received chemotherapy other than described above
- The patient has been treated with radiotherapy of the retroperitoneum
- The patient is in a reduced general condition or has a life-threatening illness
- The patient has a psychiatric illness
- Evidence of non-seminomatous germ cell tumour on RPLND histology
- Complete resection cannot be safely guaranteed due to previous surgery
- In the high risk group: contraindications to cisplatin, etoposide or bleomycin (severe hepatic insufficiency, severe renal insufficiency, severe pulmonary insufficiency, hypersensitivity, severe bone marrow depression, marked hearing impairment).

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression-free survival at 3 years

Secondary Outcome Measures

Name	Time	Method
- Time to progression (TTP) from surgery date<br>- Cancer-specific survival (CSS) and overall survival (OS)<br>- Intraoperative complications according to Intraoperative Adverse Incident Classification (EAUiaiC) by the European Association of Urology ad hoc Complications Guidelines Panel. <br>- Perioperative complications and long-term complications according to Clavien Dindo<br>- Health-related quality of life and mental health <br>- Rate of patients with postoperative retrograde ejaculation<br>- Investigation of the novel biomarker microRNA-371 <br>- Molecular analysis (immunohistochemistry, DNA/RNA sequencing) of histological samples to identify possible prognostic factors at the cellular level<br>