THERApy De-escalation for TESTicular Cancer

NCT ID: NCT06309745

Last Updated: 2025-03-17

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-06-24
• Study Completion Date: 2025-10-02

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.

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:

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.

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

retroperitoneal lymph node dissection

Intervention Type: 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.

Carboplatin AUC10

Intervention Type: DRUG

Carboplatin AUC10

Interventions

retroperitoneal lymph node dissection

retroperitoneal lymph node dissection

Intervention Type: PROCEDURE

Carboplatin AUC10

Carboplatin AUC10

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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.

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

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

• Minimum Eligible Age: 16 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Queen Mary University of London

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Prabhakar Rajan

Role: PRINCIPAL_INVESTIGATOR

Queen Mary University of London

Locations

Barts and London Hospital NHS Trust

London, , United Kingdom

Site Status: RECRUITING

Countries

United Kingdom

Central Contacts

Theratest study coordinator

Role: CONTACT

bci-theratest@qmul.ac.uk

020 7882 8478

Facility Contacts

THERATEST Study coordinator

Role: primary

Other Identifiers

THERATEST

Identifier Type: -

Identifier Source: org_study_id