Germ Cell Tumor

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 investigating new treatments for advanced ovarian cancer that is non-HRD positive. The study aims to find out if maintenance treatment with sacituzumab tirumotecan (sac-TMT), alone or combined with bevacizumab, helps people live longer without their cancer worsening compared to standard care. This is a phase 3 trial involving participants who have completed surgery and first-line platinum-based chemotherapy. Participants will be assigned randomly to one of two groups. One group will receive sac-TMT infusions every two weeks on days 1, 15, and 29 of a six-week cycle, potentially combined with bevacizumab infusions every three weeks on days 1 and 22 for up to 22 cycles. The other group will receive either bevacizumab alone on the same schedule or be observed without treatment, depending on their assigned standard care option. Treatment continues until cancer progression, unacceptable side effects, or other reasons to stop. During the trial, participants will have regular visits for treatment and monitoring, including assessments of cancer progression and side effects. Researchers will measure how long participants live without cancer worsening (progression-free survival) for up to about 49 months and monitor overall survival and quality of life for up to about 78 months. Various health questionnaires will be used to track physical function, symptoms, and well-being. Safety and treatment tolerability will also be carefully evaluated throughout the study period.

This research aims to establish a cohort to study the comprehensive management of ovarian cancer, including fallopian tube cancer and primary peritoneal cancer. It focuses on evaluating the effects of surgery, chemotherapy, and maintenance therapies on patient prognosis and quality of life. The study also investigates postoperative recovery, complications, adverse reactions, and analyzes factors influencing outcomes in these cancers. Participants will not receive any intervention as this is an observational study. Researchers will monitor patients undergoing standard treatments including surgery, chemotherapy, and targeted maintenance therapies such as PARPi. The study explores the safety and effectiveness of these treatments in real-world clinical settings without altering patient care. During the study, participants will be followed up to assess survival outcomes such as progression-free survival and overall survival about six months after study completion. Researchers will also track adverse reactions and monitor recovery and complications after treatments. The total participation period varies, with follow-ups focusing on long-term prognosis and safety.

Researchers are conducting a multicenter observational study to understand hereditary ovarian cancer among Chinese patients. The study aims to describe the clinical and genetic features of hereditary ovarian cancer and establish a risk prediction model to estimate cancer risk in first-degree relatives of mutation carriers. It also seeks to identify new tumor-causing mutations in families with hereditary ovarian cancer where known genetic causes are not found. Participants include patients diagnosed with epithelial ovarian cancer, divided into two groups: those with suspected gene mutations or a family history of cancer, and those without these factors. The study will follow these groups from 2024 to 2026 to analyze clinical, pathological, and genetic information. Through genetic sequencing and family history, the research team will explore new genetic mechanisms and verify the risk prediction model. Participants will undergo genetic testing and clinical evaluations over the study period from 2024 to 2026. Researchers will collect data on tumor features, gene mutations, and family histories. The primary outcome is to describe clinicopathological and genetic characteristics of hereditary ovarian cancer. Secondary outcomes include monitoring new ovarian cancer cases in first-degree relatives. The study aims to guide personalized diagnosis, treatment, and preventive interventions for high-risk families.

Ovarian cancer is a serious health concern with the highest death rate among gynecological cancers. Diagnosing ovarian cancer definitively requires surgery since current tests cannot reliably distinguish between benign and malignant ovarian abnormalities before surgery. Researchers are evaluating the Cleo Diagnostics (CleoDX) Ovarian Adnexal Mass Score Test System, which measures five blood biomarkers to better assess the likelihood of cancer in patients with ovarian masses needing surgery. This test aims to help doctors make more informed decisions about surgery and patient care by providing a more accurate pre-surgical cancer risk assessment. The study involves patients with ovarian cysts or adnexal masses identified by imaging who require surgery but have not yet undergone it. The CleoDX test analyzes blood samples to generate a score indicating cancer risk, and patients are categorized after surgery as having malignant or benign masses. The study compares the CleoDX test results to standard clinical assessments and post-surgical pathology to evaluate the test's accuracy and performance. Participants will provide blood samples before surgery, and their clinical and pathological information will be collected and analyzed. The primary outcome is the calculation of the CleoDX adnexal mass score, with secondary outcomes comparing the test's score to clinical and pathological findings. Data analysis will take place after patient recruitment, continuing for up to 12 months or until the study ends in August 2026. The study involves monitoring and evaluating the test's ability to predict cancer risk accurately before surgery.

This research aims to evaluate the feasibility of using pembrolizumab, an immunotherapy drug, before surgery in patients with post-molar gestational trophoblastic neoplasia (GTN), a rare pregnancy-related condition involving abnormal growth of placental cells. The study focuses on patients with low-risk, recurrent GTN who have not responded fully to initial surgical treatment. By exploring pembrolizumab as a less toxic alternative to chemotherapy, the trial hopes to find safer treatment options for these patients. Participants will be randomly assigned to one of two groups: one group will receive a second surgical removal alone, while the other will receive a single intravenous dose of pembrolizumab followed by surgery. Twenty patients in total will be recruited and evenly divided between these two groups. The study will take place at a single hospital and will include follow-up monitoring for one year after surgery. During the study, participants will undergo assessments including blood tests to measure hormone levels, imaging tests such as chest X-rays to check for disease spread, and evaluations of overall health and organ function. The main goal is to determine if delivering pembrolizumab before surgery is practical and acceptable. Researchers will also monitor the safety of this approach and compare the rates of surgical cure between the two groups. Participants' health will be tracked for up to one year following treatment.

This research aims to provide continued access to the drug niraparib and further understand its long-term safety in participants who are currently being treated with niraparib in previous GlaxoSmithKline/TESARO-sponsored studies that have completed their main goals. The study includes adults with ovarian or breast cancers who are benefiting from niraparib treatment as judged by their doctor. Participants will take niraparib once daily by mouth continuously in 90-day cycles. The dose will be the same as what they received in their prior study. They will continue treatment until disease progression, unacceptable side effects, starting a new anticancer therapy not part of the previous study, withdrawal of consent, or other reasons decided by the doctor or participant. During the study, participants will attend scheduled visits where researchers will monitor side effects, physical health including vital signs and physical exams, lab tests, and overall wellbeing up to five years. They will track adverse events, changes in performance status, blood tests, and use of other medications. This long-term follow-up helps collect important safety information while participants continue niraparib treatment under medical supervision.

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.