Actively Recruiting
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
Eligibility Criteria
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
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
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single event
Participants undergo robot-assisted retroperitoneal lymph node dissection to remove cancerous lymph nodes.
1 surgery visit
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
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
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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