SeminomaPhase 2NCT06144736
PRIMETEST II - Clinical Stage II A/B Seminoma Treated With RA-RPLND
A Phase 2 study testing Robot-assisted retroperitoneal lymph node dissection and Adjuvant therapy with one cycle of cisplatin, etoposide and bleomycin in people with Seminoma, run by Heinrich-Heine University, Duesseldorf at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years, men only
- Conditions the study is for
- Seminoma
- What is being tested?
- Robot-assisted retroperitoneal lymph node dissection and Adjuvant therapy with one cycle of cisplatin, etoposide and bleomycin
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- 28 Aug 2023to 31 Aug 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
University Hospital of Duesseldorf
Düsseldorf
Yue Che, yue.che@med.uni-duesseldorf.de
Peter Albers, peter.albers@med.uni-duesseldorf.de
About this study
Official title: PRIMETEST II - Phase II Trial to Prospectively Test New Predictors for Recurrence in Patients With Clinical Stage II A/B Seminoma Treated With RA-RPLND
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.
Read the detailed description
Testicular cancer stands as the most prevalent cancer among young men, boasting a highly favorable prognosis characterized by almost unaltered long-term survival even in advanced stages. However, traditional treatments like chemotherapy and radiation are linked to significant long-term toxicity and increased rates of secondary malignancies. Particularly, late toxicities, mainly cardiovascular, substantially diminish overall survival by approximately 6-7 years. To circumvent unnecessary acute and long-term toxicities associated with radiation or chemotherapy, it's crucial to explore alternative therapeutic avenues through personalized, less toxic approaches.
Building upon the hypothesis-generating PRIMETEST I study, PRIMETEST II is a single-arm, non-randomized prospective study. It aims to explore novel and personalized predictive parameters for recurrence following a robot-assisted primary retroperitoneal lymph node dissection (pRA-RPLND) in patients with clinical stage IIA/B seminoma (involving low-volume metastatic disease up to 5 cm). These patients represent a rare subgroup among testicular cancer patients, making a randomized comparison of treatment options impractical due to their low prevalence. The overarching goal is to reduce long-term toxicity in this young cohort of cancer patients and enhance their quality of life through personalized clinical and molecular predictions.
PRIMETEST I has indicated that pRA-RPLND in patients with clinical stage IIA/B seminoma led to a 70% recurrence-free survival at 32 months' follow-up. These findings suggest that pRA-RPLND could serve as an alternative to standard therapies (chemotherapy, radiotherapy) for a highly selective group of patients, effectively preventing excessive toxicity. PRIMETEST I has already identified several potential factors that predict which patients are more likely to benefit from surgical therapy alone.
In the novel prospective setting of PRIMETEST II, the study tests the identified predictive factors for recurrence. Patients exhibiting presumably low-risk features (about 70% of patients) will continue with surgery alone. Those with a presumed higher risk of recurrence will undergo robot-assisted surgery and have the option of receiving adjuvant treatment (one cycle of cisplatin, etoposide, and bleomycin). The primary endpoint is a three-year recurrence-free survival, estimated to exceed 90%. Additional objectives include exploring new predictors of recurrence at both molecular and clinical levels by analyzing serum and tissue samples from the primary tumor and metastases.
This innovative approach anticipates that 70% of patients will avoid long-term toxicity and experience excellent recurrence-free survival rates comparable to standard chemotherapy or radiation therapy.
- Conditions
- Seminoma
- Being tested
- Robot-assisted retroperitoneal lymph node dissection, Adjuvant therapy with one cycle of cisplatin, etoposide and bleomycin
- Keywords
- seminoma, low volume metastases, clinical stage IIA/B
- Medical subject headings
- Seminoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robot-assisted retroperitoneal lymph node dissectionProcedure or 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 bleomycinDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Low risk | Experimental | Criteria for "low risk":
* Absence of "high risk" criteria
* Previous carboplatin therapy post orchiectomy
* Exclusion of malignancy in the RPLND histology Receives: 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 Receives: Procedure: Robot-assisted retroperitoneal lymph node dissection; Drug: Adjuvant therapy with one cycle of cisplatin, etoposide and bleomycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
Measured: 3 years
Secondary outcomes (8)
Overall survival
Measured: at least 5 years
Time to progression
Measured: from intervention to progression assessed up to 5 years
Complications
Intraoperative Adverse Incident Classification (EAUiaiC) by the European Association of Urology ad hoc Complications Guidelines Panel, Clavien-Dindo
Measured: intra- and perioperative
Quality of life
EORTC QLQ-C30 and QLQ-TC26
Measured: baseline and yearly, up to 5 years
Mental health
Questionnaire
Measured: baseline and yearly, up to 5 years
Rate of retrograde ejaculation
Measured: postoperative assessment yearly, up to 5 years
Validation of microRNA-371
Measurements of the biomarker microRNA-371
Measured: Day before surgery, day 3-5 after surgery and in case of adjuvant therapy 3 days from last drug application
Analysis of molecular characteristics
Measurements still not specified
Measured: after study recruitment completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2023
- Study start28 Aug 2023
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SeminomaStudies of the same condition, open and under way.
- More trials run by Heinrich-Heine University, DuesseldorfThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heinrich-Heine University, Duesseldorf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yue Che, Principal investigator, University Hospital of Düsseldorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06144736
- Sponsor's protocol ID
- 2022-2256
- Status last verified
- Mar 2025
- First submitted
- 10 Nov 2023
- Last updated
- 15 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PRIMETEST II - Phase II Trial to Prospectively Test New Predictors for Recurrence in Patients With Clinical Stage II A/B Seminoma Treated With RA-RPLND
- ClinicalTrials.gov ID
- NCT06144736
- Acronym / sponsor ID
- 2022-2256
- Conditions
- Seminoma
- Keywords
- seminoma, low volume metastases, clinical stage IIA/B
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Heinrich-Heine University, DuesseldorfUniversity, hospital or other
- Study start
- 28 Aug 2023 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Aug 2029 (estimated)
- First posted
- 22 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Testicular cancer stands as the most prevalent cancer among young men, boasting a highly favorable prognosis characterized by almost unaltered long-term survival even in advanced stages. However, traditional treatments like chemotherapy and radiation are linked to significant long-term toxicity and increased rates of secondary malignancies. Particularly, late toxicities, mainly cardiovascular, substantially diminish overall survival by approximately 6-7 years. To circumvent unnecessary acute and long-term toxicities associated with radiation or chemotherapy, it's crucial to explore alternative therapeutic avenues through personalized, less toxic approaches.
Building upon the hypothesis-generating PRIMETEST I study, PRIMETEST II is a single-arm, non-randomized prospective study. It aims to explore novel and personalized predictive parameters for recurrence following a robot-assisted primary retroperitoneal lymph node dissection (pRA-RPLND) in patients with clinical stage IIA/B seminoma (involving low-volume metastatic disease up to 5 cm). These patients represent a rare subgroup among testicular cancer patients, making a randomized comparison of treatment options impractical due to their low prevalence. The overarching goal is to reduce long-term toxicity in this young cohort of cancer patients and enhance their quality of life through personalized clinical and molecular predictions.
PRIMETEST I has indicated that pRA-RPLND in patients with clinical stage IIA/B seminoma led to a 70% recurrence-free survival at 32 months' follow-up. These findings suggest that pRA-RPLND could serve as an alternative to standard therapies (chemotherapy, radiotherapy) for a highly selective group of patients, effectively preventing excessive toxicity. PRIMETEST I has already identified several potential factors that predict which patients are more likely to benefit from surgical therapy alone.
In the novel prospective setting of PRIMETEST II, the study tests the identified predictive factors for recurrence. Patients exhibiting presumably low-risk features (about 70% of patients) will continue with surgery alone. Those with a presumed higher risk of recurrence will undergo robot-assisted surgery and have the option of receiving adjuvant treatment (one cycle of cisplatin, etoposide, and bleomycin). The primary endpoint is a three-year recurrence-free survival, estimated to exceed 90%. Additional objectives include exploring new predictors of recurrence at both molecular and clinical levels by analyzing serum and tissue samples from the primary tumor and metastases.
This innovative approach anticipates that 70% of patients will avoid long-term toxicity and experience excellent recurrence-free survival rates comparable to standard chemotherapy or radiation therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Low risk | Experimental | Procedure: Robot-assisted retroperitoneal lymph node dissectionCriteria for "low risk": * Absence of "high risk" criteria * Previous carboplatin therapy post orchiectomy * Exclusion of malignancy in the RPLND histology |
| High risk | Experimental | Procedure: Robot-assisted retroperitoneal lymph node dissection, Drug: Adjuvant therapy with one cycle of cisplatin, etoposide and bleomycinCriteria for "high risk": * Clinical stage II at initial diagnosis * Primary tumor > 4 cm * Infiltration of the "rete testis" in the primary tumor |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
- Initial diagnosis of a tumor in UICC stage IIA/IIB
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Robot-assisted retroperitoneal lymph node dissectionRobot-assisted, if possibe ipsilateral nerve-sparing, retroperitoneal lymph node dissection and metastasis resection in a unilateral dissection field ("template") | Procedure or surgery | High risk, Low risk |
| Adjuvant therapy with one cycle of cisplatin, etoposide and bleomycinThe patient is given the option for an adjuvant therapy with one cycle of cisplatin, etoposide and bleomycin two to four weeks after RA-RPLND | Drug | High risk |
Primary outcome
Progression-free survival
Time frame: 3 years
8 secondary outcomes
Overall survival
Time frame: at least 5 years
Time to progression
Time frame: from intervention to progression assessed up to 5 years
Complications
Time frame: intra- and perioperative
Quality of life
Time frame: baseline and yearly, up to 5 years
Mental health
Time frame: baseline and yearly, up to 5 years
Rate of retrograde ejaculation
Time frame: postoperative assessment yearly, up to 5 years
Validation of microRNA-371
Time frame: Day before surgery, day 3-5 after surgery and in case of adjuvant therapy 3 days from last drug application
Analysis of molecular characteristics
Time frame: after study recruitment completion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2025.
- Individual participant dataSharing planned: Undecided
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Sentinel Node Identification Using Gamma and Near-Infrared Imaging in TesticulAr MaLignancies
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yue Che principal investigator
University Hospital of Düsseldorf
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Robot-assisted retroperitoneal lymph node dissection and Adjuvant therapy with one cycle of cisplatin, etoposide and bleomycin in people with Seminoma, run by Heinrich-Heine University, Duesseldorf at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yue Che (00492118118110, yue.che@med.uni-duesseldorf.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2025.