SeminomaTHERATESTNCT06309745
THERApy De-escalation for TESTicular Cancer
An observational study of Seminoma, run by Queen Mary University of London at 1 site in United Kingdom.
Trial summary
THERATEST is looking to collect data from 30 patients actively receiving de-escalation treatments or other standard of care treatments in two UK hospitals. THERATEST is a feasibility study to determine whether patients are willing to be recruited, the impact of de-escalation treatments on patients' cancers and quality… Read more about this study
- Who is it for?
- Ages 16 years and older, men only
- Conditions the study is for
- Seminoma
- What is being tested?
- retroperitoneal lymph node dissection and Carboplatin AUC10
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 24 Jun 2024to 2 Oct 2028
- Phase
- Observational
- 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 16 years and older
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Study population: A. rRPLND cohort: Patients with seminoma who are negative/low for tumour markers and unifocal ipsilateral Stage IIA or <3cm IIB will be assessed for rRPLND. Patients who are eligible for rRPLND will undergo surgery followed by adjuvant treatment or surveillance as determined by their clinical teams based on post-operative histology as per SOC. Patients who are not deemed eligible for or decline rRPLND, will be offered either BEP/EP chemotherapy or radiotherapy with or without neoadjuvant Carboplatin AUC7 and will continue to be followed in the study. B. Carboplatin AUC10 cohort: Patients with stage II seminoma will be offered Carboplatin AUC10. Those deemed ineligible for Carboplatin AUC10 or who decline this treatment option will be offered either BEP/EP chemotherapy or radiotherapy and will continue to be followed in the study.
Who may be able to join
- Each patient must meet all of the following inclusion criteria to be enrolled in the study:
- Willing and able to provide written informed consent.
- Male.
- Age ≥ 16 years.
- Histologically confirmed seminoma (biopsy/orchidectomy)
- Clinical stage II (standard of care cross-sectional imaging).
Show all 29Show fewer
- Ability to comply with the protocol, including but not limited to, completion of the patient-reported outcome questionnaires.
- rRPLND cohort specific inclusion criteria
- Participants must meet the following additional inclusion criteria to register for the rRPLND cohort:
- Stage IIA and <3cm IIB with unifocal ipsilateral lymph node within rRPLND template.
- Negative or mildly elevated serum tumour markers, defined as:
- AFP (alpha-fetoprotein) <10ng/ml and non-rising on serial testing
- BhCG (human chorionic gonadotropin) <50mg/ml
- LDH (lactate dehydrogenase) <1.5x upper limit normal
- Fit for surgery, defined as meeting all of the following criteria:
- Body mass index (BMI) <34
- Charlson comorbidity index ≤3
- ECOG Performance status 0-1
- No significant cardio-pulmonary disease, or other uncontrolled intercurrent illness that would limit fitness for surgery in the opinion of the investigator
- No previous open intra-abdominal surgery
- Carboplatin AUC10 cohort specific inclusion criteria
- Participants must meet the following additional inclusion criteria to register for the Carboplatin AUC10 group:
- Serum tumour markers, defined by IGCCCG "good risk" criteria:
- AFP <10ng/ml
- any BhCG
- LDH <2.5x ULN
- Glomerular filtration rate by EDTA clearance over 25 ml/min (a measured creatinine clearance using Cockcroft and Gault would be allowed if unable to perform EDTA clearance).
- ECOG Performance status 0-2.
- Patients must be sterile or agree to use adequate contraception during the period of therapy.
Who cannot join
- Raised AFP > 10ng/ml that does not fall to <10ng/ml following orchidectomy
- Previous chemotherapy or radiotherapy for the disease under study.
- Previous or concurrent malignancy other than testicular cancer, unless treated with curative intent and with no known active disease present for ≥2 years before enrolment and felt to be at low risk for recurrence by the treating physician (for example: non-melanoma skin cancer or lentigo maligna; breast ductal carcinoma in situ; prostatic intraepithelial neoplasia; urothelial papillary non-invasive carcinoma or urothelial carcinoma in situ).
- Any condition that, in the opinion of the investigator, would interfere with evaluation of study intervention or interpretation of patient safety or study results such as medical comorbidities impacting on QoL or medical conditions or other disorders that would affect adherence to study requirements
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Barts and London Hospital NHS Trust
London
THERATEST Study coordinator
About this study
THERATEST is looking to collect data from 30 patients actively receiving de-escalation treatments or other standard of care treatments in two UK hospitals. THERATEST is a feasibility study to determine whether patients are willing to be recruited, the impact of de-escalation treatments on patients' cancers and quality of life, whether we should proceed with these treatments in a larger study, and if so how the study should be conducted. A feasibility study prepares the ground for a larger study and improves the chances of the subsequent study producing valuable evidence, and helps to avoid wasting precious resources on larger trials that are unlikely to be informative. We hope that information from THERATEST will bridge the current knowledge gap and allow clinicians to design bigger trials to actively compare the different treatment strategies.
Read the detailed description
THERATEST is an observational cohort study of patients receiving SOC treatments (combination chemotherapy or radiotherapy) or de-escalated treatments (primary rRPLND or Carboplatin AUC10) treatments for stage II seminoma.
Potential patients will be identified and invited to join the THERATEST study. Patients will be allocated to the following cohorts based on whether the relevant mode of treatment is adopted as an institutional SOC in their respective institution:
- rRPLND cohort: Patients with seminoma who are negative/low for tumour markers and unifocal ipsilateral Stage IIA or <3cm IIB will be assessed for rRPLND. Patients who are eligible for rRPLND will undergo surgery followed by adjuvant treatment or surveillance as determined by their clinical teams based on post-operative histology as per SOC. Patients who are not deemed eligible for or decline rRPLND, will be offered either BEP/EP chemotherapy or radiotherapy with or without neoadjuvant Carboplatin AUC7 and will continue to be followed in the study.
- Carboplatin AUC10 cohort: Patients with stage II seminoma will be offered Carboplatin AUC10. Those deemed ineligible for Carboplatin AUC10 or who decline this treatment option will be offered either BEP/EP chemotherapy or radiotherapy and will continue to be followed in the study.
Chemotherapy treatment strategies and adjuvant treatments are left to the shared decision-making between treating clinician and patient and follow institutional SOC. In both cohorts patients will be followed up for 2 years after treatment completion or until death or withdrawal of consent, whichever is the earliest. Beyond the study period, patients will be follow up as per institutional SOC protocols as part of prospective institutional audits.
- Conditions
- Seminoma
- Being tested
- retroperitoneal lymph node dissection, Carboplatin AUC10
- Medical subject headings
- Seminoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
retroperitoneal lymph node dissectionProcedure or surgery
retroperitoneal lymph node dissection
Carboplatin AUC10Drug
Carboplatin AUC10
| Study group | Role | What they receive |
|---|---|---|
| RPLND cohort | Patients with seminoma who are negative/low for tumour markers and unifocal ipsilateral Stage IIA or <3cm IIB will be assessed for rRPLND. Patients who are eligible for rRPLND will undergo surgery followed by adjuvant treatment or surveillance as determined by their clinical teams based on post-operative histology as per SOC. Patients who are not deemed eligible for or decline rRPLND, will be offered either BEP/EP chemotherapy or radiotherapy with or without neoadjuvant Carboplatin AUC7 and will continue to be followed in the study. Receives: Procedure: retroperitoneal lymph node dissection | |
| Carboplatin AUC10 cohort | Patients with stage II seminoma will be offered Carboplatin AUC10. Those deemed ineligible for Carboplatin AUC10 or who decline this treatment option will be offered either BEP/EP chemotherapy or radiotherapy and will continue to be followed in the study. Receives: Drug: Carboplatin AUC10 |
What is being measured
The primary outcome is the main question the study is designed to answer.
FEASIBILITY of recruitment and retention
To demonstrate feasibility of recruitment and retention (number of participants recruited per month and retained annually). Completion of recruitment of 30 patients into the THERATEST study, and measurement of overall patient retention within the trial until the 2-year follow-up visit.
Measured: through study completion, an average of 3 year
Secondary outcomes (5)
QUALITY OF LIFE assessed by difference in HRQOL scores
To determine differences in Health-related QOL (HRQOL) before and after treatment(s). Change in domain scale scores/single item scores in European Organisation for Research and Treatment of Cancer (EORTC) QLQ-TC26 and EORTC QLQ-C30, measured from baseline until the 2-year follow-up visit.
Measured: through study completion, an average of 3 year
QUALITY OF LIFE assessed by difference in differences in sexual drive, function, and overall satisfaction
To determine differences in sexual drive, function, and overall satisfaction before and after treatment(s). Change in domain scale scores/single item scores in Brief Male Sexual Function Inventory (BMSFI), QLQ-TC26, and supplementary questions on retrograde ejaculation. Measured from baseline until the 2-year follow-up visit.
Measured: through study completion, an average of 3 year
Progression free SURVIVAL
- To determine progression-free survival (PFS) and overall survival (OS) rates ensuring these fall in line with standard of care treatments outcomes (>95%). PFS rate at 2 years, defined as the proportion of patients who did not experience disease progression or death from any cause during the 2-year follow-up period.
Measured: through study completion, an average of 3 year
OVERALL SURVIVAL
- To determine progression-free survival (PFS) and overall survival (OS) rates ensuring these fall in line with standard of care treatments outcomes (>95%). OS rate at 2 years, defined as the proportion of patients who did not experience death from any cause during the 2-year follow-up period.
Measured: through study completion, an average of 3 year
SAFETY and complication of all treatments
- To assess the safety and complications of all treatments. Incidence, nature and severity of adverse events with severity determined according to CTCAE v5.0 collected from consent until 6 weeks post-surgery or chemotherapy.
Surgical complications will be assessed by the Clavien-Dindo scoring system, and analysing details of surgical complications, blood transfusion, ITU admission and dialysis rates from patient records up to 6 months post-rRPLND.
Measured: through study completion, an average of 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2024
- Study start24 Jun 2024
- Primary completion2 Oct 2028 (estimated)
- Study completion2 Oct 2028 (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 Queen Mary University of LondonThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Queen Mary University of London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Prabhakar Rajan, Principal investigator, Queen Mary University of London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06309745
- Sponsor's protocol ID
- THERATEST
- Acronym
- THERATEST
- Status last verified
- Feb 2026
- First submitted
- 8 Sep 2023
- Last updated
- 2 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THERApy De-escalation for TESTicular Cancer
- ClinicalTrials.gov ID
- NCT06309745
- Acronym / sponsor ID
- THERATEST / THERATEST
- Conditions
- Seminoma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Queen Mary University of LondonUniversity, hospital or other
- Study start
- 24 Jun 2024 (actual)
- Primary completion
- 2 Oct 2028 (estimated)
- Study completion
- 2 Oct 2028 (estimated)
- First posted
- 13 Mar 2024 (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.
THERATEST is looking to collect data from 30 patients actively receiving de-escalation treatments or other standard of care treatments in two UK hospitals. THERATEST is a feasibility study to determine whether patients are willing to be recruited, the impact of de-escalation treatments on patients' cancers and quality of life, whether we should proceed with these treatments in a larger study, and if so how the study should be conducted. A feasibility study prepares the ground for a larger study and improves the chances of the subsequent study producing valuable evidence, and helps to avoid wasting precious resources on larger trials that are unlikely to be informative. We hope that information from THERATEST will bridge the current knowledge gap and allow clinicians to design bigger trials to actively compare the different treatment strategies.
Detailed description
THERATEST is an observational cohort study of patients receiving SOC treatments (combination chemotherapy or radiotherapy) or de-escalated treatments (primary rRPLND or Carboplatin AUC10) treatments for stage II seminoma.
Potential patients will be identified and invited to join the THERATEST study. Patients will be allocated to the following cohorts based on whether the relevant mode of treatment is adopted as an institutional SOC in their respective institution:
- rRPLND cohort: Patients with seminoma who are negative/low for tumour markers and unifocal ipsilateral Stage IIA or <3cm IIB will be assessed for rRPLND. Patients who are eligible for rRPLND will undergo surgery followed by adjuvant treatment or surveillance as determined by their clinical teams based on post-operative histology as per SOC. Patients who are not deemed eligible for or decline rRPLND, will be offered either BEP/EP chemotherapy or radiotherapy with or without neoadjuvant Carboplatin AUC7 and will continue to be followed in the study.
- Carboplatin AUC10 cohort: Patients with stage II seminoma will be offered Carboplatin AUC10. Those deemed ineligible for Carboplatin AUC10 or who decline this treatment option will be offered either BEP/EP chemotherapy or radiotherapy and will continue to be followed in the study.
Chemotherapy treatment strategies and adjuvant treatments are left to the shared decision-making between treating clinician and patient and follow institutional SOC. In both cohorts patients will be followed up for 2 years after treatment completion or until death or withdrawal of consent, whichever is the earliest. Beyond the study period, patients will be follow up as per institutional SOC protocols as part of prospective institutional audits.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RPLND cohort | – | Procedure: retroperitoneal lymph node dissectionPatients with seminoma who are negative/low for tumour markers and unifocal ipsilateral Stage IIA or <3cm IIB will be assessed for rRPLND. Patients who are eligible for rRPLND will undergo surgery followed by adjuvant treatment or surveillance as determined by their clinical teams based on post-operative histology as per SOC. Patients who are not deemed eligible for or decline rRPLND, will be offered either BEP/EP chemotherapy or radiotherapy with or without neoadjuvant Carboplatin AUC7 and will continue to be followed in the study. |
| Carboplatin AUC10 cohort | – | Drug: Carboplatin AUC10Patients with stage II seminoma will be offered Carboplatin AUC10. Those deemed ineligible for Carboplatin AUC10 or who decline this treatment option will be offered either BEP/EP chemotherapy or radiotherapy and will continue to be followed in the study. |
Who may qualify
- Ages
- 16 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- A. rRPLND cohort: Patients with seminoma who are negative/low for tumour markers and unifocal ipsilateral Stage IIA or <3cm IIB will be assessed for rRPLND. Patients who are eligible for rRPLND will undergo surgery followed by adjuvant treatment or surveillance as determined by their clinical teams based on post-operative histology as per SOC. Patients who are not deemed eligible for or decline rRPLND, will be offered either BEP/EP chemotherapy or radiotherapy with or without neoadjuvant Carboplatin AUC7 and will continue to be followed in the study. B. Carboplatin AUC10 cohort: Patients with stage II seminoma will be offered Carboplatin AUC10. Those deemed ineligible for Carboplatin AUC10 or who decline this treatment option will be offered either BEP/EP chemotherapy or radiotherapy and will continue to be followed in the study.
Key inclusion criteria (29 listed)
- Each patient must meet all of the following inclusion criteria to be enrolled in the study:
- Willing and able to provide written informed consent.
- Male.
- Age ≥ 16 years.
- Histologically confirmed seminoma (biopsy/orchidectomy)
Key exclusion criteria (4 listed)
- Raised AFP > 10ng/ml that does not fall to <10ng/ml following orchidectomy
- Previous chemotherapy or radiotherapy for the disease under study.
- Previous or concurrent malignancy other than testicular cancer, unless treated with curative intent and with no known active disease present for ≥2 years before enrolment and felt to be at low risk for recurrence by the treating physician (for example: non-melanoma skin cancer or lentigo maligna; breast ductal carcinoma in situ; prostatic intraepithelial neoplasia; urothelial papillary non-invasive carcinoma or urothelial carcinoma in situ).
- Any condition that, in the opinion of the investigator, would interfere with evaluation of study intervention or interpretation of patient safety or study results such as medical comorbidities impacting on QoL or medical conditions or other disorders that would affect adherence to study requirements
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 |
|---|---|---|
| retroperitoneal lymph node dissectionretroperitoneal lymph node dissection | Procedure or surgery | RPLND cohort |
| Carboplatin AUC10Carboplatin AUC10 | Drug | Carboplatin AUC10 cohort |
Primary outcome
FEASIBILITY of recruitment and retention
Time frame: through study completion, an average of 3 year
To demonstrate feasibility of recruitment and retention (number of participants recruited per month and retained annually). Completion of recruitment of 30 patients into the THERATEST study, and measurement of overall patient retention within the trial until the 2-year follow-up visit.
5 secondary outcomes
QUALITY OF LIFE assessed by difference in HRQOL scores
Time frame: through study completion, an average of 3 year
QUALITY OF LIFE assessed by difference in differences in sexual drive, function, and overall satisfaction
Time frame: through study completion, an average of 3 year
Progression free SURVIVAL
Time frame: through study completion, an average of 3 year
OVERALL SURVIVAL
Time frame: through study completion, an average of 3 year
SAFETY and complication of all treatments
Time frame: through study completion, an average of 3 year
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 2 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Seminoma
Active, not recruitingPhase 2
Evaluating Immune Therapy, Duravalumab (MEDI4736) With Tremelimumab for Relapsed/Refractory Germ Cell Tumors
Germ Cell Tumor, Nonseminomatous Germ Cell Tumor
RecruitingPhase 2
De-escalation Study for Stage IIa/IIb < 3 cm Seminoma
Seminoma, Stage II
RecruitingObservational study
Sentinel Node Identification Using Gamma and Near-Infrared Imaging in TesticulAr MaLignancies
Germ Cell Tumor of Testis
RecruitingPhase 3
Active Surveillance, Bleomycin, Etoposide, Carboplatin or Cisplatin in Treating Pediatric and Adult Patients With Germ Cell Tumors
Childhood Extracranial Germ Cell Tumor, Extragonadal Embryonal Carcinoma
Active, not recruitingPhase 2
Nivolumab and Ipilimumab in Treating Patients With Rare Tumors
Acinar Cell Carcinoma, Adenoid Cystic Carcinoma
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.
Prabhakar Rajan principal investigator
Queen Mary University of London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Seminoma, run by Queen Mary University of London at 1 site in United Kingdom.
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 29 inclusion and 4 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 2 Mar 2026. 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 United Kingdom. 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.
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 Theratest study coordinator (020 7882 8478, bci-theratest@qmul.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FEASIBILITY of recruitment and retention (time frame: through study completion, an average of 3 year). 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 2 Mar 2026.