Actively Recruiting

Phase 2
Age: 18Years - 99Years
MALE
ID06144736

PRIMETEST II - Phase II Trial to Test New Predictors for Recurrence in Clinical Stage II A/B Seminoma Treated With Robot-Assisted Retroperitoneal Lymph Node Dissection

Led by Heinrich-Heine University, Duesseldorf · Updated on 2025-09-15

60

Participants Needed

1

Research Sites

156 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating a new treatment approach for men with low-volume metastatic seminoma, a type of testicular cancer. This study, called PRIMETEST II, builds on previous research and aims to reduce the long-term side effects often caused by standard treatments like chemotherapy and radiation. By using robot-assisted surgery, the study hopes to improve quality of life and identify factors that predict cancer recurrence, allowing for more personalized care. The study involves a robot-assisted primary retroperitoneal lymph node dissection (RA-RPLND) to remove affected lymph nodes. Patients are divided into two groups based on risk factors: those with low risk will have surgery alone, while higher-risk patients may receive surgery followed by one cycle of chemotherapy with cisplatin, etoposide, and bleomycin. This personalized approach is designed to avoid unnecessary chemotherapy and its side effects for most patients. Participants will be monitored over several years to assess outcomes such as recurrence-free survival at three years, overall survival, quality of life, mental health, and potential complications from surgery. Researchers will also analyze tissue and blood samples to explore molecular markers linked to recurrence. The study includes yearly assessments for up to five years to gauge physical and mental health and track any side effects, aiming for a tailored treatment strategy that maintains excellent survival while minimizing long-term toxicity.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 99Years
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Histologically confirmed pure seminomatous testicular germ cell tumor
  • Presence of iliac or retroperitoneal lymph node metastasis detected by CT or MRI, local or unilateral
  • Lymph node metastases measuring 5 cm or less in size
  • HCG level at staging examination not exceeding 5 IU/L if elevated after orchiectomy
  • Initial diagnosis in UICC stage IIA/IIB or recurrence in clinical stage I under surveillance or after carboplatin mono adjuvant therapy
Not Eligible

You will not qualify if you...

  • Lymph node metastases larger than 5 cm (UICC IIC) or other metastases (UICC III)
  • Prior chemotherapy different from carboplatin mono
  • Previous retroperitoneal radiotherapy
  • Reduced general health or life-threatening illness
  • Psychiatric illness
  • Non-seminomatous germ cell tumor components in surgery histology
  • Incomplete resection due to prior surgeries
  • For high-risk group: contraindications to cisplatin, etoposide, or bleomycin such as severe liver, kidney, or lung issues, hypersensitivity, bone marrow depression, or hearing impairment

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery

Duration - Single event

Participants undergo robot-assisted retroperitoneal lymph node dissection to remove cancerous lymph nodes.

1 surgery visit

Adjuvant Therapy (for high-risk participants)

Duration - One cycle administered over several days

Participants with higher risk of recurrence may receive one cycle of chemotherapy with cisplatin, etoposide, and bleomycin two to four weeks after surgery.

1 to 2 visits for chemotherapy administration and monitoring

Follow-up and Monitoring

Duration - Up to 5 years

Participants are monitored for recurrence, quality of life, mental health, and side effects including retrograde ejaculation, with assessments at baseline and yearly up to 5 years.

Yearly visits for up to 5 years

Trial Site Locations

Total: 1 location

1

University Hospital of Duesseldorf

Düsseldorf, Germany

Actively Recruiting

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Research Team

Y

Yue Che

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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