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

ConditionSeminoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age18-99
SponsorHeinrich-Heine University, Duesseldorf

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Robot-assisted retroperitoneal lymph node dissection

    Procedure/Surgery

    Robot-assisted, if possibe ipsilateral nerve-sparing, retroperitoneal lymph node dissection and metastasis resection in a unilateral dissection field ("template")

  • Adjuvant therapy with one cycle of cisplatin, etoposide and bleomycin

    Drug

    The patient is given the option for an adjuvant therapy with one cycle of cisplatin, etoposide and bleomycin two to four weeks after RA-RPLND

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Low riskExperimental treatment 1 intervention
Group B: High riskExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Progression-free survival

Time frame
3 years

Secondary outcomes

1

Overall survival

Time frame
at least 5 years
2

Time to progression

Time frame
from intervention to progression assessed up to 5 years
3

Complications

Intraoperative Adverse Incident Classification (EAUiaiC) by the European Association of Urology ad hoc Complications Guidelines Panel, Clavien-Dindo

Time frame
intra- and perioperative
4

Quality of life

EORTC QLQ-C30 and QLQ-TC26

Time frame
baseline and yearly, up to 5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Heinrich-Heine University, Duesseldorf

Lead sponsor

Source ClinicalTrials.gov
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