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

NCT06144736 | Recruiting Phase 2 DMC

• 1 other identifier: 2022-2256
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Seminoma

Keywords

seminoma; low volume metastases; clinical stage IIA/B

Outcome Measures

Primary Outcomes (1)

• Progression-free survival

  3 years

Secondary Outcomes (8)

• Overall survival

  at least 5 years

• Time to progression

  from intervention to progression assessed up to 5 years

• Complications

  intra- and perioperative

• Quality of life

  baseline and yearly, up to 5 years

• Mental health

  baseline and yearly, up to 5 years

Study Arms (2)

Low risk

EXPERIMENTAL

Criteria for "low risk": * Absence of "high risk" criteria * Previous carboplatin therapy post orchiectomy * Exclusion of malignancy in the RPLND histology

Procedure: Robot-assisted retroperitoneal lymph node dissection

High risk

EXPERIMENTAL

Criteria for "high risk": * Clinical stage II at initial diagnosis * Primary tumor \> 4 cm * Infiltration of the "rete testis" in the primary tumor

Procedure: Robot-assisted retroperitoneal lymph node dissection; Drug: Adjuvant therapy with one cycle of cisplatin, etoposide and bleomycin

Interventions

Robot-assisted retroperitoneal lymph node dissection PROCEDURE

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

High risk; Low risk

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

High risk

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Heinrich-Heine University, Duesseldorf: lead

Study Sites (1)

University Hospital of Duesseldorf

Düsseldorf, Germany

RECRUITING

MeSH Terms

Conditions

Seminoma

Interventions

Etoposide; Bleomycin

Condition Hierarchy (Ancestors)

Germinoma; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates; Glycopeptides; Glycoconjugates; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Yue Che

  University Hospital of Düsseldorf

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yue Che

CONTACT

00492118118110; yue.che@med.uni-duesseldorf.de

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The patients are classified as "low risk" or "high risk" for recurrence upon study enrollment. "Low risk" patients undergo a robot-assisted retroperitoneal lymph node dissection and metastasis resection (RA-RPLND) in a unilateral dissection field ("template") without adjuvant therapy. "High risk" patients also undergo a retroperitoneal lymph node dissection and metastasis resection in a unilateral dissection field, but additionally have the option to receive adjuvant therapy with one cycle of PEB two to four weeks after the RA-RPLND.

Study Record Dates

• First Submitted: November 10, 2023
• First Posted: November 22, 2023
• Study Start: August 28, 2023
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2029
• Last Updated: September 15, 2025

Record last verified: 2025-03

Locations

DE (1)