Testicular Cancer

Researchers are studying men with metastatic castration-resistant prostate cancer mCRPC to understand how different PETCT scans can predict outcomes during radioligand therapy with 177Lu-PSMA-617. This is an exploratory, prospective study conducted at a single center, focusing on imaging tumor heterogeneity to help assess therapy effects and patient response. The study is designed specifically for Veterans undergoing this treatment. Participants will receive several types of PETCT scans at different times before starting LuPSMA radioligand therapy RLT, and then after the 2nd, 4th, and 6th treatment cycles. These scans include 18F-Fluciclovine PETCT Axumin, 18F-DCFPyL PETCT, and 18F-FDG PETCT. The 18F-Fluciclovine scans will be performed within seven days of the PSMA PET scans to compare imaging results at each time point. During the study, detailed imaging measures such as lesion uptake and tumor volume will be collected and analyzed over time. Patients will be followed at the institution to correlate these imaging results with clinical outcomes. The main outcome measured is the impact of 18F-Fluciclovine PETCT on predicting outcomes of the 177Lu-PSMA-617 therapy from enrollment through 34 weeks of treatment.

Researchers are evaluating a new behavioral intervention called Goal-focused Emotion-Regulation Therapy GET aimed at reducing distress, improving emotion regulation, goal navigation skills, and stress-sensitive biomarkers in young adult men diagnosed with testicular cancer. This randomized controlled trial compares GET to Individual Supportive Listening ISL to understand their effects on psychological and biological outcomes. The study focuses on young adults aged 18 to 39 who have completed chemotherapy and experience distress related to their cancer. Participants will be randomly assigned to receive either six sessions of GET or ISL over eight weeks. GET helps patients identify meaningful personal goals, refine them, and develop strategies to overcome obstacles while improving emotional regulation and sense of purpose. ISL provides supportive, non-directive therapy focused on listening and encouraging expression of thoughts and feelings. Both interventions are delivered individually via an interactive video platform to improve access. During the study, participants will complete assessments at baseline, immediately after treatment, and at three- and six-month follow-ups. These include questionnaires measuring depression, anxiety, emotion regulation, goal navigation, career confusion, and spiritual well-being. Researchers will also collect biological samples to measure stress hormones and inflammatory markers. The study aims to evaluate the feasibility, acceptability, and effects of these interventions on psychological distress and biological stress indicators in young adult testicular cancer survivors.

Testicular cancer is a rare adult cancer but the most common solid tumor in young men, with about 90% being germ cell tumors classified as seminoma or non-seminoma. Around 20% of seminoma patients have clinical stage II disease with limited retroperitoneal lymph node metastases. This trial explores an alternative to standard radiotherapy or chemotherapy treatments, which carry risks of serious short- and long-term side effects, by evaluating the role of surgery called Primary Retroperitoneal Lymph Node Dissection RPLND.

Researchers are studying tumors in the genitourinary GU tract, including cancers of the kidney, bladder, prostate, testicles, penis, and rare types such as neuroendocrine cancers. This study aims to better understand both common and rare urinary tract cancers, especially those so rare that they are not often included in treatment studies or tissue banks. The goal is to gather detailed information about the natural history and characteristics of these cancers to improve diagnosis and treatment. Participants will be part of a long-term, multi-center observational study where their medical histories will be collected and followed over time. They may provide tissue samples, blood, and urine for scientific studies, including genetic testing. Imaging scans of the chest, abdomen, and pelvis may be done, sometimes with contrast agents. Optional tumor biopsies may be performed up to twice a year to collect samples. Participants will receive recommendations about cancer management and treatment and can ask questions throughout the study. During the study, participants will have physical exams, provide clinical photographs of skin lesions, and complete surveys about family cancer history. Follow-up visits will occur frequently, and if participants cannot visit the study center, their home doctors will be contacted to continue monitoring. The study will track disease progression, treatment responses, and other clinical information over the participants lifetimes. The primary outcome measure is understanding the natural history of urothelial and rare genitourinary cancers.

Researchers are evaluating a new PET imaging agent called 68Ga-MY6349 to improve diagnosis and monitoring of prostate cancer and other aggressive tumors. This study aims to overcome limitations of current methods like PSA tests and PSMA PETCT, which may miss some tumors or lack detailed tumor information. The new probe targets Trop2, a protein highly expressed in many cancers, to provide a whole-tumor assessment in living patients, supporting earlier diagnosis and better treatment planning. Participants will receive a single injection of the 68Ga-MY6349 tracer followed by PETCT imaging to visualize cancer presence and activity. This novel agent is compared to existing imaging agents like 68Ga-PSMA-11, with hopes of detecting more lesions and providing more sensitive and specific results. The study involves a single administration and imaging session per participant. During the study, participants undergo PETCT scans after receiving the tracer to assess tumor detection and uptake. Researchers will measure diagnostic accuracy over two years, including counting the number of lesions and standardized uptake values SUV to evaluate tracer performance. The trial includes safety monitoring and requires participant consent and adherence to the imaging protocol, lasting up to two years for outcome evaluation.

This research evaluates a new imaging method combining electromagnetic tracking with laparoscope and ultrasound probe imaging to improve surgeries for patients with confirmed urologic cancers. These cancers may affect the bladder, prostate, testicle, kidney, urethra, penis, ureter, or scrotum. The study aims to enhance visualization and localization of affected areas during lymph node dissection or organ removal surgeries, potentially reducing complexity, complications, and improving outcomes. Participants will undergo surgeries using a standard laparoscope and ultrasound probe equipped with an electromagnetic sensor to track lymph nodes or organs of interest. This imaging protocol is expected to record data in under 10 minutes during the procedure. The study is a pilot trial involving 10 participants and is supported by Siemens Medical USA. Participants will be monitored through laparoscope and ultrasound images and electromagnetic tracking data over one year. Researchers will assess the accuracy of navigation retrospectively. The involvement includes scheduled surgeries with laparoscopic lymph node dissection andor organ removal, supported by imaging and tracking to evaluate this novel approach. The study is led by Dana-Farber Cancer Institute and runs until December 2026.

Researchers are evaluating CTIM-76, a CLDN6-directed T cell-engaging bispecific antibody, in people with platinum-refractory or resistant ovarian cancer and other advanced CLDN6-positive solid tumors such as testicular and endometrial cancers. This Phase 1a1b open-label study aims to assess the safety, tolerability, and effectiveness of CTIM-76 in these patients. The study includes a dose escalation portion to determine the recommended dose for expansion, followed by a dose expansion phase to evaluate different dose levels and schedules. In the dose escalation phase Phase 1a, participants receive CTIM-76 once according to their assigned dose cohort, with about 9 dose groups planned. Treatment continues until disease progression, unacceptable side effects, or a decision to stop by the participant or physician. The dose expansion phase Phase 1b will study at least two dose levels or schedules in approximately 80 participants to better understand the dose-response relationship. The final recommended dose will be selected based on all collected safety, pharmacokinetic, pharmacodynamic, biomarker, and preliminary efficacy data. Participants will be monitored for dose-limiting toxicities within 28 days after the first dose and overall response rate up to 24 months. Assessments include disease measurement per RECIST 1.1 criteria, organ function, and overall health. Safety and response data guide dosing decisions. The total duration of participation depends on treatment continuation and disease progression, with ongoing evaluations throughout the study period ending in 2028.

Researchers are evaluating the safety and effectiveness of a combination treatment using adebrelimab and XELOX chemotherapy around the time of surgery for patients with surgically removable gastric cancer or adenocarcinoma of the gastroesophageal junction. This Phase II trial aims to improve outcomes for patients with locally advanced stages of this cancer, as current treatments still face challenges like high recurrence rates despite surgery and chemotherapy. The study focuses on how well this combination approach works before and after surgery to reduce cancer recurrence and improve survival. Participants receive neoadjuvant therapy consisting of three cycles of adebrelimab 1200 mg intravenously every 3 weeks combined with XELOX chemotherapy oxaliplatin 130 mgm2 IV on day 1, and capecitabine 1000 mgm2 orally twice daily from days 1 to 14, every 3 weeks. Surgery is scheduled within 3 to 6 weeks after this treatment. Following surgery, participants receive five cycles of adjuvant therapy with the same doses of adebrelimab and XELOX chemotherapy. Additionally, adebrelimab maintenance therapy continues for up to one year, with a total of no more than eight cycles of the perioperative combination treatment. During the study, participants will undergo assessments including pathological response evaluation after surgery, imaging, and follow-up visits for up to one year to measure outcomes such as pathological complete response, major pathological response, objective response rate, and survival rates. Researchers will monitor safety through adverse events and serious adverse events. The total study duration includes treatment and follow-up periods, with long-term survival tracked up to three years. This comprehensive monitoring aims to assess the treatments impact on cancer control and patient well-being.

Researchers are evaluating the plasma expression of miRNA 371a-3p miRNA 371 as a specific marker to detect the presence or absence of viable germ cell malignancy in male patients newly diagnosed with testicular germ cell tumors or those with a history of this cancer. This observational cohort study aims to understand how well miRNA 371 can indicate relapse risk in early-stage testicular seminoma and nonseminoma groups. The study is sponsored by Fondazione del Piemonte per lOncologia and focuses on measuring miRNA levels and relapse outcomes over 48 months. Patients are grouped based on their risk of relapse low risk 5-25% chance or moderate risk 26-50% chance. Those in the low-risk group will follow a low-intensity schedule involving biospecimen collection and imaging, while the moderate-risk group will have a higher intensity schedule including additional early imaging and classic cancer marker tests. The study observes these patients without administering any investigational treatments. Participants will undergo regular blood tests to measure miRNA 371 levels and classic tumor markers like beta-HCG, AFP, and LDH. Imaging and clinical evaluations will be done within 42 days before registration and monitored over the 48-month study period. Researchers will track relapse rates, relapse-free survival, and overall survival, collecting pathology reports and performance status data. Participants must provide informed consent and blood samples throughout the study duration.

Researchers are studying adults with advanced germ cell cancer who are at high risk for venous thromboembolism VTE. The study aims to evaluate the rate of participants who remain free of VTE for six months while receiving standard cisplatin-based chemotherapy combined with low-dose aspirin acetylsalicylic acid, ASA, comparing outcomes to historical data. This is a single-arm Phase II trial involving participants with stage IS or IIA or higher testicular or germ cell cancer. Participants will take a fixed low dose of aspirin 81 mg orally every day for 26 weeks alongside their standard chemotherapy. The study is designed in two stages first enrolling 13 participants, with expansion to a total of 31 if initial results show promising VTE prevention. Participants provide their own aspirin supply and will stop aspirin if they experience a VTE, switching to standard anticoagulation therapy as directed by their doctors. During the study, participants will be monitored for VTE events and bleeding risks over 26 weeks. Researchers will also assess relapse-free survival and overall survival up to two years after starting chemotherapy. Participants must be able to swallow oral medications and comply with study procedures throughout the treatment period. This study is sponsored by Wake Forest University Health Sciences and may include additional sites beyond the initial center.