Testicular Cancer

Researchers are studying men with metastatic castration-resistant prostate cancer (mCRPC) to understand how different PET/CT 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 PET/CT 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 PET/CT (Axumin), 18F-DCFPyL PET/CT, and 18F-FDG PET/CT. 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 PET/CT 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, which includes cancers of the kidney, bladder, prostate, testicles, penis, and neuroendocrine cancers. Some of these tumors are rare and not well represented in treatment studies or tissue banks, making it difficult to establish standard care. This research aims to better understand both common and rare GU tumors by collecting detailed patient information over time. Participants in this long-term, multi-center observational study will provide medical history and may undergo physical exams, blood and urine sample collection, and surveys about family cancer history. Imaging scans of the chest, abdomen, and pelvis may be performed, sometimes with contrast injections. Patients may also provide existing tumor samples or optional biopsies. Samples may be used for genetic testing, and various scientific analyses including genomics and immune monitoring will be conducted. Throughout the study, participants will have regular follow-up visits and ongoing monitoring of their health, either at the research site or through coordination with their home doctors. Researchers will track disease patterns, treatment responses, and disease progression to characterize the natural history of GU cancers. This study will continue to follow patients over their lifetime to gather comprehensive data and improve future diagnosis and treatment strategies.

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 PET/CT, 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 PET/CT 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 PET/CT 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 and/or 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 a Phase 1a/1b open-label study for participants with platinum-refractory or resistant ovarian cancer and other advanced CLDN6-positive solid tumors like testicular and endometrial cancers. The study aims to assess the safety, tolerability, and preliminary efficacy of this investigational drug in these patients. The study includes a Phase 1a dose escalation portion where participants receive CTIM-76 once weekly on days 1, 8, 15, and 22 of a 28-day cycle, across approximately nine dose cohorts to determine the recommended dose for expansion. The Phase 1b dose expansion will evaluate at least two dose levels or dosing schedules in about 80 participants to analyze dose and exposure responses. Participants continue treatment until disease progression, unacceptable toxicity, or decision to stop treatment. Participants will undergo evaluation for dose-limiting toxicities during the first 28 days after the first dose and overall response rates up to 24 months. Assessments include measures of disease progression and safety monitoring. The study involves regular dosing cycles and ongoing observation to collect pharmacokinetic, pharmacodynamic, biomarker, and efficacy data. Participation duration varies based on individual treatment response and tolerability.

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 mg/m2 IV on day 1, and capecitabine 1000 mg/m2 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 treatment's 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 l'Oncologia 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 evaluating the rate of venous thromboembolism (VTE) over six months in participants with advanced germ cell cancer who are at high risk of VTE. The study focuses on those receiving standard cisplatin-based chemotherapy combined with low-dose acetylsalicylic acid (ASA). This Phase II, single-arm trial compares results to historical data to understand how well ASA may prevent VTE in this specific population. Participants will self-administer a fixed daily dose of 81 mg ASA by mouth for 26 weeks alongside their chemotherapy. The study has two stages: initially, 13 participants will be enrolled, and if most do not experience VTE during the first 26 weeks, an additional 18 participants will join. If a participant develops VTE, they will stop ASA and start standard anticoagulation treatment. The trial is initially conducted at a single center with plans to add more sites later. During the study, participants will be closely monitored for VTE events and bleeding complications. Researchers will assess VTE occurrence at 26 weeks, and secondary outcomes include major and non-major bleeding events, relapse-free survival, and overall survival up to two years after starting chemotherapy. Participants will provide their own ASA supply and are expected to comply with daily medication and study procedures throughout the trial duration.