Robot-assisted surgery for low-volume metastatic seminoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• University Hospital of Duesseldorf
  Düsseldorf, Germany Recruiting

Study contacts

• Principal investigator: Yue Che — University Hospital of Düsseldorf
• Study coordinator: Yue Che
• Email: yue.che@med.uni-duesseldorf.de
• Phone: 00492118118110

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Primary retroperitoneal lymph node surgery versus chemotherapy for good‑prognosis metastatic testicular cancer

  This study will test whether primary RPLND (surgery) instead of standard chemotherapy leads to fewer side effects and better quality of life for men 18 and older with good‑prognosis metastatic testicular cancer.

  Recruiting Sahlgrenska University Hospital · Gothenburg, Göteborg · NCT07498959

• De-escalation treatments for stage II seminoma

  This study is testing whether less intense treatments for stage II seminoma can help patients feel better and manage their cancer just as well as standard treatments.

  Recruiting Queen Mary University of London · London · NCT06309745

• Robot-assisted biopsy for testicular cancer

  This study is testing a new robot-assisted method for taking biopsies in men with testicular cancer to see if it can more accurately find hidden cancer and reduce unnecessary treatments.

  Recruiting Heinrich-Heine University, Duesseldorf · Düsseldorf · NCT06133543

• De-escalation treatment for early-stage seminoma

  This study is testing whether giving less treatment after surgery for early-stage seminoma can still be effective while reducing side effects for patients.

  Recruiting at 12 sites Phase 2 Centre Leon Berard · Besançon and 14 other locations · NCT05529251

• Comparing radiotherapy and observation for residual seminoma after chemotherapy

  This study is testing whether giving radiotherapy or just watching closely is better for patients with advanced seminoma who still have leftover masses after chemotherapy.

  Recruiting Tata Memorial Centre · Mumbai, Maharashtra and 1 other locations · NCT05142982

• Using microRNA to improve testicular cancer management

  This study is testing if a specific microRNA can help doctors better detect and manage testicular cancer by identifying active tumor cells in patients.

  Recruiting at 4 sites Haukeland University Hospital · Bergen and 5 other locations · NCT04914026

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.