De-escalation treatments for stage II seminoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

THERATEST is an observational study collecting data from patients with stage II seminoma receiving either standard of care treatments or de-escalation treatments in two UK hospitals. The study aims to assess patient willingness to participate, the effects of de-escalation treatments on cancer progression and quality of life, and to gather insights that could inform larger future studies. Patients will be categorized into cohorts based on their treatment options, including retroperitoneal lymph node dissection (rRPLND) or Carboplatin AUC10. The findings will help bridge knowledge gaps and guide the design of more extensive trials.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Each patient must meet all of the following inclusion criteria to be enrolled in the study:

1. Willing and able to provide written informed consent.
2. Male.
3. Age ≥ 16 years.
4. Histologically confirmed seminoma (biopsy/orchidectomy)
5. Clinical stage II (standard of care cross-sectional imaging).
6. 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:

1. Stage IIA and \<3cm IIB with unifocal ipsilateral lymph node within rRPLND template.
2. Negative or mildly elevated serum tumour markers, defined as:

   1. AFP (alpha-fetoprotein) \<10ng/ml and non-rising on serial testing
   2. BhCG (human chorionic gonadotropin) \<50mg/ml
   3. LDH (lactate dehydrogenase) \<1.5x upper limit normal
3. Fit for surgery, defined as meeting all of the following criteria:

   1. Body mass index (BMI) \<34
   2. Charlson comorbidity index ≤3
   3. ECOG Performance status 0-1
   4. No significant cardio-pulmonary disease, or other uncontrolled intercurrent illness that would limit fitness for surgery in the opinion of the investigator
   5. 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:

1. Serum tumour markers, defined by IGCCCG "good risk" criteria:

   1. AFP \<10ng/ml
   2. any BhCG
   3. LDH \<2.5x ULN
2. 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).
3. ECOG Performance status 0-2.
4. Patients must be sterile or agree to use adequate contraception during the period of therapy.

Exclusion Criteria:

1. Raised AFP \> 10ng/ml that does not fall to \<10ng/ml following orchidectomy
2. Previous chemotherapy or radiotherapy for the disease under study.
3. 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).
4. 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

Where it's running

• Barts and London Hospital NHS Trust
  London, United Kingdom Recruiting

Study contacts

• Principal investigator: Prabhakar Rajan — Queen Mary University of London
• Study coordinator: Theratest study coordinator
• Email: bci-theratest@qmul.ac.uk
• Phone: 020 7882 8478

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Primary retroperitoneal lymph node surgery versus chemotherapy for good‑prognosis metastatic testicular cancer

  This study will test whether primary RPLND (surgery) instead of standard chemotherapy leads to fewer side effects and better quality of life for men 18 and older with good‑prognosis metastatic testicular cancer.

  Recruiting Sahlgrenska University Hospital · Gothenburg, Göteborg · NCT07498959

• Robot-assisted surgery for low-volume metastatic seminoma

  This study is testing if robot-assisted surgery can help patients with low-volume metastatic seminoma avoid long-term side effects and improve their quality of life while also figuring out how to personalize their treatment.

  Recruiting Phase 2 Heinrich-Heine University, Duesseldorf · Düsseldorf · NCT06144736

• Robot-assisted biopsy for testicular cancer

  This study is testing a new robot-assisted method for taking biopsies in men with testicular cancer to see if it can more accurately find hidden cancer and reduce unnecessary treatments.

  Recruiting Heinrich-Heine University, Duesseldorf · Düsseldorf · NCT06133543

• De-escalation treatment for early-stage seminoma

  This study is testing whether giving less treatment after surgery for early-stage seminoma can still be effective while reducing side effects for patients.

  Recruiting at 12 sites Phase 2 Centre Leon Berard · Besançon and 14 other locations · NCT05529251

• Comparing radiotherapy and observation for residual seminoma after chemotherapy

  This study is testing whether giving radiotherapy or just watching closely is better for patients with advanced seminoma who still have leftover masses after chemotherapy.

  Recruiting Tata Memorial Centre · Mumbai, Maharashtra and 1 other locations · NCT05142982

• Using microRNA to improve testicular cancer management

  This study is testing if a specific microRNA can help doctors better detect and manage testicular cancer by identifying active tumor cells in patients.

  Recruiting at 4 sites Haukeland University Hospital · Bergen and 5 other locations · NCT04914026

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.