Actively Recruiting

Age: 16Years +
MALE
NCT06309745

THERApy De-escalation for TESTicular Cancer

Led by Queen Mary University of London · Updated on 2026-03-02

30

Participants Needed

1

Research Sites

223 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

THERApy De-escalation for TESTicular Cancer

Who Can Participate

Age: 16Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Willing and able to provide written informed consent
  • Male
  • Age 16 years or older
  • Histologically confirmed seminoma (biopsy or orchidectomy)
  • Clinical stage II confirmed by imaging
  • Able to comply with study procedures including patient questionnaires
  • For rRPLND cohort: Stage IIA or <3cm IIB with unifocal ipsilateral lymph node within rRPLND template
  • For rRPLND cohort: Negative or mildly elevated serum tumour markers (AFP <10ng/ml and non-rising, BhCG <50mg/ml, LDH <1.5x upper limit normal)
  • For rRPLND cohort: Fit for surgery (BMI <34, Charlson comorbidity index ≤3, ECOG 0-1, no significant cardio-pulmonary or uncontrolled illness, no previous open intra-abdominal surgery)
  • For Carboplatin AUC10 cohort: Serum tumour markers meeting IGCCCG good risk criteria (AFP <10ng/ml, any BhCG, LDH <2.5x upper limit normal)
  • For Carboplatin AUC10 cohort: Glomerular filtration rate over 25 ml/min by EDTA clearance or creatinine clearance
  • For Carboplatin AUC10 cohort: ECOG performance status 0-2
  • For Carboplatin AUC10 cohort: Patient must be sterile or agree to use adequate contraception during therapy
Not Eligible

You will not qualify if you...

  • Raised AFP >10ng/ml that does not fall below 10ng/ml after orchidectomy
  • Previous chemotherapy or radiotherapy for testicular cancer
  • Previous or concurrent malignancy other than testicular cancer unless treated with curative intent and no active disease for at least 2 years, and considered low risk for recurrence (e.g., certain skin cancers, breast ductal carcinoma in situ, prostate intraepithelial neoplasia, some urothelial carcinomas)
  • Any medical condition that could interfere with study treatment evaluation, patient safety, or adherence, as judged by the investigator

AI-Screening

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Trial Site Locations

Total: 1 location

1

Barts and London Hospital NHS Trust

London, United Kingdom

Actively Recruiting

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Research Team

T

Theratest study coordinator

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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