THERApy De-escalation for TESTicular Cancer

NCT06309745 | Recruiting

• 1 other identifier: THERATEST
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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 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

Seminoma

Outcome Measures

Primary Outcomes (1)

• 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.

  through study completion, an average of 3 year

Secondary Outcomes (5)

• QUALITY OF LIFE assessed by difference in HRQOL scores

  through study completion, an average of 3 year

• QUALITY OF LIFE assessed by difference in differences in sexual drive, function, and overall satisfaction

  through study completion, an average of 3 year

• Progression free SURVIVAL

  through study completion, an average of 3 year

• OVERALL SURVIVAL

  through study completion, an average of 3 year

• SAFETY and complication of all treatments

  through study completion, an average of 3 year

Study Arms (2)

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.

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.

Drug: Carboplatin AUC10

Interventions

Carboplatin AUC10 DRUG

Carboplatin AUC10

Carboplatin AUC10 cohort

retroperitoneal lymph node dissection PROCEDURE

retroperitoneal lymph node dissection

RPLND cohort

Eligibility Criteria

• Age: 16 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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).
• Ability to comply with the protocol, including but not limited to, completion of the patient-reported outcome questionnaires.
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Queen Mary University of London: lead

Study Sites (1)

Barts and London Hospital NHS Trust

London, United Kingdom

RECRUITING

MeSH Terms

Conditions

Seminoma

Condition Hierarchy (Ancestors)

Germinoma; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Prabhakar Rajan

  Queen Mary University of London

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Theratest study coordinator

CONTACT

020 7882 8478; bci-theratest@qmul.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2023
• First Posted: March 13, 2024
• Study Start: June 24, 2024
• Primary Completion (Estimated): October 2, 2028
• Study Completion (Estimated): October 2, 2028
• Last Updated: March 2, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)