Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Rare Diseases

Endodermal Sinus Tumor

Teratoma

Testicular Neoplasms

Retroperitoneal Neoplasms

Testicular Diseases

Choriocarcinoma

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Endocrine Gland Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Male Urogenital Diseases

Endocrine System Diseases

Gonadal Disorders

Trophoblastic Neoplasms

Adenocarcinoma

Carcinoma

Neoplasms, Glandular and Epithelial

Pregnancy Complications

Pregnancy Complications, Neoplastic

Female Urogenital Diseases

Female Urogenital Diseases and Pregnancy Complications

Abdominal Neoplasms

Germ Cells Tumors

Testicular Germ Cell Tumor

Testicular Yolk Sac Tumor

Only one arm is being evaluated--the arm receiving PET scan

Axumin PET scan

Yair Lotan, MD

Investigators will use Axumin PET/CT to help with the imaging modalities to determine the presence of occult retroperitoneal disease.

Investigators aim to perform a prospective study of anti-18F-FACBC PET/CT in patients with NSGCT prior to RPLND, either in the primary setting or in the post-chemotherapy setting. We will correlate histopathologic outcomes from the RPLND specimen and clinical outcomes of recurrence during follow-up to identify the accuracy of anti-18F-FACBC PET/CT in these settings.

Males with germ cell tumors (testicular cancer)

Role of Axumin PET Scan in Germ Cell Tumor

Anti-1-amino-3-18F-flurocyclobutane-1-carboxylic Acid (Axumin) Positron Emission Tomography/Computed Tomography Prior to Retroperitoneal Lymph Node Dissection for Testicular Cancer

Investigate the accuracy of anti-18F-FACBC PET/CT correlating with histopathologic outcomes

University of Texas Southwestern Medical Center

Professor of Urology

Blood and Lymph Conditions

Lymphadenopathy

Seminoma

Germinoma

Lymphatic Diseases

Testicular Seminoma

Central Nervous System Germinoma

Laboratory Biomarker Analysis

Retroperitoneal Lymph Node Dissection

Siamak Daneshmand

This phase II trial studies how well retroperitoneal lymph node dissection (RPLND) works in treating patients with stage I-IIa testicular seminoma. The retroperitoneum is the space in the body behind the intestines that is typically the first place that seminoma spreads. RPLND is a surgery that removes lymph nodes in this area to treat testicular seminoma and may experience fewer long-term toxicities, such as a second cancer, cardiovascular disease, metabolic syndrome (pre-diabetes), or lung disease.

PRIMARY OBJECTIVES:

I. Assess the recurrence free survival (RFS) at 2 years after RPLND when RPLND is used as a first line treatment for patients with testicular seminoma and low volume (=\< 2cm) retroperitoneal disease.

SECONDARY OBJECTIVES:

I. Estimate the percent of patients, after treatment with RPLND, who can avoid external beam radiotherapy (XRT) or systemic chemotherapy (CTX) for seminoma.

II. Assess the complications associated with primary RPLND for seminoma.

OUTLINE:

Patients undergo RPLND.

After completion of study treatment, patients are followed up at 1 month, every 4 months for 1 year, every 6 months for 2 years, and then annually thereafter.

Retroperitoneal Lymph Node Dissection in Treating Patients With Testicular Seminoma

Surgery in Early Metastatic Seminoma (SEMS): Phase II Trial of Retroperitoneal Lymph Node Dissection as First-Line Treatment for Testicular Seminoma With Isolated Retroperitoneal Disease (1-3cm)

Associated 95% confidence intervals will be constructed. Actuarial RFS will be calculated by the Kaplan Meier method. The recurrence location (pelvic, retroperitoneal, distant) will be calculated as a percentage of total recurrences to describe the clinical pattern of disease after relapse.

The rate of short and long term complications will be calculated.

Associated 95% confidence intervals will be constructed. Actuarial RFS will be calculated by the Kaplan Meier method.

National Cancer Institute (NCI)

University of Southern California

Antineoplastic Agents

All Drugs and Chemicals

Carboplatin

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.

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.

retroperitoneal lymph node dissection

Carboplatin AUC10

Theratest study coordinator

THERATEST Study coordinator

Prabhakar Rajan

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.

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.

THERApy De-escalation for TESTicular Cancer

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.

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.

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.

• 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.

• 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.

• 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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Role of Axumin PET Scan in Germ Cell Tumor	NCT03426865	Testis Cancer Germ Cell Tumor Testicular Canc... Germ Cell Tumor... Germ Cell Tumor... Testicular Neop... Testicular Germ... Testicular Yolk... Testicular Chor... Testicular Dise... Germ Cell Cance... Germ Cell Neopl... Germ Cell Cance...	Axumin PET scan	18 Years -	University of Texas Southwestern Medical Center
Retroperitoneal Lymph Node Dissection in Treating Patients With Testicular Seminoma	NCT02537548	Lymphadenopathy Stage I Testicu... Stage II Testic...	Laboratory Biom... Retroperitoneal...	16 Years -	University of Southern California
Retroperitoneal Lymph Node Dissection in Treating Patients With Testicular Seminoma	NCT02537548	Lymphadenopathy Stage I Testicu... Stage II Testic...	Laboratory Biom... Retroperitoneal...	16 Years -	University of Southern California
THERApy De-escalation for TESTicular Cancer	NCT06309745	Seminoma	retroperitoneal... Carboplatin AUC...	16 Years -	Queen Mary University of London
THERApy De-escalation for TESTicular Cancer	NCT06309745	Seminoma	retroperitoneal... Carboplatin AUC...	16 Years -	Queen Mary University of London

Spots Global Cancer Trial Database for retroperitoneal lymph node dissection