Kurate

This research focuses on men with prostate cancer who have previously participated in an enzalutamide clinical study sponsored by Astellas or Medivation. It aims to gather long-term safety information from participants who continue to benefit from enzalutamide treatment. This is a Phase 2 open-label extension study designed to monitor ongoing treatment effects after the initial study has completed its primary analysis or evaluation period. Participants will continue their previous treatment regimens, which may include enzalutamide taken orally once daily. Some may also receive abiraterone acetate with prednisone or leuprolide acetate depending on their prior study enrollment. Dose adjustments are allowed with medical monitor approval. The first visit of this study should occur within seven days of the last visit of the prior study unless treatment is temporarily paused. Participants are asked to return to their study site every 24 weeks for safety reviews, including adverse event monitoring and medication checks. At visits every 12 weeks, participants return unused study drugs and receive new supplies if needed. Safety data, including all adverse events and serious adverse events, are collected from consent until study completion, which may last up to 96 months. The study follows local standard care guidelines and includes a post-marketing phase in South Korea.

Researchers are evaluating the effectiveness of active surveillance and chemotherapy treatments in pediatric, adolescent, and adult patients with low risk and standard risk germ cell tumors. This phase III trial focuses on monitoring patients after tumor removal and comparing the outcomes of carboplatin-based versus cisplatin-based chemotherapy regimens. The study aims to maintain high overall survival rates for low risk patients and to compare event-free survival between the two chemotherapy options in standard risk patients. Additional objectives include assessing side effects such as hearing loss and neuropathy, and exploring tumor marker changes and other biological measures related to treatment outcomes. Patients with low risk stage I germ cell tumors undergo surgery followed by observation, with the option to transfer to standard risk treatment if the tumor recurs. Those with standard risk tumors are randomly assigned to one of four chemotherapy regimens combining bleomycin, etoposide, carboplatin, or cisplatin. Treatments are given intravenously on specific schedules every 21 days for up to 3 or 4 cycles, depending on the group. Throughout the trial, patients receive imaging scans, blood tests, tumor biopsies if needed, and pulmonary function tests to monitor treatment response and side effects. Participants are closely followed after treatment completion with regular visits every 2 months for the first year, then less frequently up to 10 years. Researchers collect data through imaging, blood samples, lung tests, and questionnaires to measure survival, disease recurrence, and side effects like hearing loss. The study also includes exploratory analyses of tumor markers and patient-reported outcomes to better understand treatment impacts and improve future care for germ cell tumor patients.

Researchers are evaluating whether adding preoperative chemotherapy before surgery improves outcomes for patients with high-risk dedifferentiated liposarcoma (DDLPS) and leiomyosarcoma (LMS) located in the retroperitoneal or pelvic areas. This phase III trial compares standard surgery alone to surgery combined with chemotherapy, aiming to increase disease-free survival in these patients. High-risk tumors are carefully defined by specific pathological and imaging criteria to select appropriate participants. Participants are randomly assigned to one of two groups. The standard group undergoes large, en-bloc curative surgery within four weeks of randomization. The experimental group receives three cycles of chemotherapy—doxorubicin plus ifosfamide for high-grade liposarcoma, or doxorubicin plus dacarbazine for leiomyosarcoma—starting within two weeks after randomization. After chemotherapy, operability is reassessed and surgery is performed within three to six weeks following the last chemotherapy cycle. Chemotherapy doses may be adjusted according to guidelines but must meet minimum thresholds. During the study, patients undergo imaging to measure their tumors and provide tumor tissue and blood samples for pathology and research. Eligibility includes performance status, organ function, and use of effective birth control for those of reproductive potential. Researchers monitor disease-free survival over seven years from the first patient's enrollment. Safety, treatment response, and other health assessments are part of the follow-up during and after treatment.