PRIMETEST II - Clinical Stage II A/B Seminoma Treated With RA-RPLND

• Status: Recruiting
• Trial end date: 2029-08-31
• Target enrollment: 0
• Participant gender: Male

Summary

PRIMETEST II is an interventional study involving low-volume metastatic seminoma. It explores a novel approach using robot-assisted primary retroperitoneal lymph node dissection, aiming to reduce long-term side effects and improve quality of life. By identifying factors predicting cancer recurrence, the study hopes to tailor treatments for better outcomes. The approach could potentially spare patients from chemotherapy induced long-term side effects while maintaining excellent survival rates, presenting a promising shift in testicular cancer care for this specific patient group.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Heinrich-Heine University, Duesseldorf
• Treatments: Bleomycin; Etoposide

Criteria

Inclusion Criteria:

• Histologically confirmed pure seminomatous testicular germ cell tumor

• Presence of iliac or retroperitoneal lymph node metastasis detected in contrast-enhanced CT or MRI, classified as local or unilaterally regional

• Maximum extent of lymph node metastasis (LN-M) singular or multiple, with a maximum size of 5 cm in transverse CT diameter (UICC IIB)

• Patients with an elevation in HCG after orchiectomy at the time of staging examination can be included if the directly preoperatively determined HCG does not exceed 5 IU/L.

Patients can be included in the following scenarios:

• Initial diagnosis of a tumor in UICC stage IIA/IIB

• Recurrence of a tumor in clinical stage (CS) I under active surveillance

• Recurrence of a CS I tumor after adjuvant therapy with carboplatin mono

Exclusion Criteria:

• LN-M with a transverse diameter >5 cm in CT (UICC IIC)

• Other metastases than LN-M (UICC III)

• The patient received a different chemotherapy than described above

• The patient underwent retroperitoneal radiotherapy

• 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 tumor components in the RPLND histology

• Complete resection cannot be ensured due to previous surgeries

• In the "high risk" group: Contraindications to cisplatin, etoposide, or bleomycin (severe liver insufficiency, severe kidney insufficiency, severe lung insufficiency, hypersensitivity, severe bone marrow depression, profound hearing impairments)