Robot-assisted surgery for low-volume metastatic seminoma

PRIMETEST II - Phase II Trial to Prospectively Test New Predictors for Recurrence in Patients With Clinical Stage II A/B Seminoma Treated With RA-RPLND

This study is testing if robot-assisted surgery can help patients with low-volume metastatic seminoma avoid long-term side effects and improve their quality of life while also figuring out how to personalize their treatment.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 99 Years
• Sex: Male
• Sponsor: Heinrich-Heine University, Duesseldorf (Academic / other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 1 site (Düsseldorf)
• Trial ID: NCT06144736 on ClinicalTrials.gov

What this trial studies

PRIMETEST II is an interventional study focusing on patients with low-volume metastatic seminoma, utilizing robot-assisted primary retroperitoneal lymph node dissection (pRA-RPLND) to minimize long-term side effects and enhance quality of life. The study aims to identify predictive factors for cancer recurrence, allowing for personalized treatment approaches. By avoiding traditional chemotherapy and radiation, which can lead to significant long-term toxicity, this study seeks to improve patient outcomes while maintaining high survival rates. It builds on insights from the earlier PRIMETEST I study, targeting a rare subgroup of testicular cancer patients.

Who should consider this trial

Good fit: Ideal candidates include young men with histologically confirmed pure seminomatous testicular germ cell tumors and low-volume lymph node metastases.

Not a fit: Patients with larger lymph node metastases or those with other metastases beyond the lymph nodes may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the long-term side effects associated with traditional cancer treatments for seminoma patients.

How similar studies have performed: Previous studies, such as PRIMETEST I, have shown promising results with similar approaches, indicating potential for success in this novel intervention.

Eligibility 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)

Where this trial is running

Düsseldorf

• University Hospital of Duesseldorf — Düsseldorf, Germany (Recruiting)

Study contacts

• Principal investigator: Yue Che — University Hospital of Düsseldorf
• Study coordinator: Yue Che

Conditions Seminoma; seminoma; low volume metastases; clinical stage IIA/B