Hengelo

Researchers are evaluating a new treatment called ifinatamab deruxtecan (I-DXd) for men with metastatic castration-resistant prostate cancer (mCRPC). This study compares I-DXd to chemotherapy to see if it helps people live longer overall and live longer without their cancer worsening. It is a Phase 3, open-label trial focused on patients who have progressed on prior therapies and have evidence of metastatic disease. Participants receive either I-DXd through an intravenous infusion every 3 weeks or docetaxel chemotherapy administered every 3 weeks. Prednisone tablets are also given daily as part of the treatment plan. Before each I-DXd dose, premedication is provided to help prevent nausea and vomiting using a combination of drugs such as corticosteroids and anti-nausea medicines. Treatment continues until disease progression, unacceptable side effects, or other reasons to stop. During the study, researchers monitor overall survival and how long patients live without their cancer progressing, for up to about 36 months. Participants undergo tumor tissue collection, scans, and assessments to track disease status and side effects. Safety is closely watched throughout treatment. The study includes men aged 18 and older with confirmed prostate cancer and metastatic disease who have previously received certain hormone therapies but no prior taxane chemotherapy for mCRPC.

Researchers are evaluating the use of Autologous Fat Transfer (AFT) with pre-expansion as a full breast reconstruction method for female breast cancer patients who have undergone or will undergo mastectomy. This multicenter prospective cohort study aims to monitor the quality of life, aesthetic outcomes, complications, oncological safety, and cost-effectiveness of AFT. The study builds on the previous BREAST trial that compared AFT with implant-based reconstruction, but here all patients receive AFT. Participants in this study will undergo full breast reconstruction using AFT combined with an external expansion device. This procedure is offered to women who have had or are candidates for mastectomy, including those undergoing preventive mastectomy. The external expansion device must be worn by participants to assist the reconstruction process. There is no comparator group in this study as all patients receive the AFT treatment. During the study, participants will be followed for at least two years to evaluate breast-related quality of life and other outcomes. Researchers will monitor safety, aesthetic results, and complications throughout this period. Patients will be assessed regularly to track their progress and any adverse effects related to the treatment, with particular attention to oncological safety and overall well-being after reconstruction.

This trial studies men with low-volume, hormone-sensitive metastatic prostate cancer to evaluate if a shorter treatment duration with androgen receptor pathway inhibitors (ARPIs) like Apalutamide or Enzalutamide is as effective as continuous therapy. The purpose is to see if stopping ARPI treatment after 12 months, with the option to restart if the cancer progresses, can reduce side effects and costs without worsening outcomes. This is a Phase 3 randomized nationwide study focusing on patients with low-volume metastatic disease confirmed by imaging and clinical assessment. Participants will receive androgen deprivation therapy (ADT) combined with either continuous ARPI treatment or ARPI treatment stopped at 12 months. Those who stop ARPI after 12 months may restart treatment if their PSA levels rise, confirmed by a second test at least 4 weeks later. The study compares these two approaches to understand if shorter ARPI use is non-inferior to continuous use, aiming to reduce treatment toxicity while maintaining disease control. Participants will be followed for up to 6 years, with clinical progression-free survival as the main outcome. Researchers will monitor time from study inclusion to disease progression or treatment end. Patients will undergo regular assessments including PSA testing and clinical evaluations to track disease status. Safety and treatment effects will be closely observed throughout the study period, which includes up to 5 years of active follow-up after randomization.

Researchers are evaluating the AtMoves Knee System to improve the diagnosis of aseptic loosening in patients who have had total knee arthroplasty (knee replacement surgery). The study aims to determine if using this device can reduce the number of failed outcomes, defined as insufficient improvement in knee function reported by patients 12 months after diagnosis. The trial compares patients who receive an additional CT scan with the AtMoves Knee System to those who do not, while both groups may undergo other diagnostic tests as needed. The AtMoves Knee System is a device that applies controlled force to the knee during a CT scan to detect tiny movements in the tibial component of the knee prosthesis, which may indicate loosening. Participants will be divided into two groups: one will have the extra CT scan with the device, and the other will receive standard care without the device. Both groups continue with any other diagnostic procedures their doctors recommend. During the one-year follow-up, all participants will complete questionnaires about their knee condition and symptoms. Researchers will track changes in patient-reported outcomes to see how well the device helps in diagnosing loosening. The main outcome measured is the rate of patients with failed outcomes at 12 months. This study involves adults aged 18 years or older who have had knee replacement surgery and are suspected of having aseptic loosening but need further diagnostic help.

Acute urinary retention (AUR) is a sudden and painful condition where a man cannot urinate, often caused by an enlarged prostate known as benign prostatic hyperplasia (BPH). This condition is typically treated by inserting a catheter to empty the bladder and starting medication that relaxes the prostate. The study evaluates the safety and effectiveness of removing the catheter at different times after insertion, aiming to find the optimal duration before attempting to urinate without the catheter, called a Trial Without Catheter (TWOC). Men in this study will all receive a catheter and begin or continue alpha-blocker medication. Participants are randomly assigned to one of two groups: one will have their catheter removed after three days, and the other after fourteen days. This randomized controlled trial compares these two timelines to see if a shorter catheter duration is as successful as a longer one in allowing normal urination without needing the catheter replaced. During the study, researchers will monitor whether participants need to be re-catheterized either three or fourteen days after catheter removal. They will also assess complications, patient comfort with the catheter, quality of life, and healthcare costs. The results aim to improve care for men with AUR by reducing unnecessary catheterization time, discomfort, and complications, helping doctors decide the best time to remove the catheter.

Researchers are evaluating the effectiveness of the MiLES intervention, a web-based program designed for employers, to improve the successful return to work (RTW) of employees diagnosed with cancer within the past two years. This randomized controlled trial also aims to assess the cost-effectiveness and return on investment of the MiLES intervention compared to usual care. The study includes 140 employer-employee dyads, focusing on both the employee's and employer's outcomes related to RTW and quality of life. Employers in the intervention group will have unlimited access to the MiLES website, which offers interactive videos, conversation checklists, tips, information about RTW guidance, involved stakeholders, and relevant legislation. These resources intend to support employers in effectively communicating with and assisting their employees with cancer during sick leave and return to work. The control group will receive care as usual without access to the MiLES intervention. Participants will complete questionnaires at the start of the study and at 3, 6, and 12 months after enrollment to assess outcomes such as successful RTW, quality of life, work-related support, and satisfaction with support. Employers will report on their self-efficacy in providing RTW support and satisfaction with the RTW process. The follow-up period lasts 12 months, and a process evaluation based on the UK Medical Research Council framework will also be conducted.

Researchers are evaluating a new breast reconstruction method called autologous fat transfer (AFT) for women with breast cancer who have had or will have a mastectomy. This multicenter randomized controlled trial compares AFT using the EVEBRA device to AFT without the device. The study will assess the method's effectiveness based on breast volume, quality of life, appearance, complications, and cancer safety. Participants will be divided into two groups: one group will use the EVEBRA device which involves wearing it for 2 weeks before surgery for a total of 200 hours, and then for 10 hours daily for 2 weeks after surgery; the other group will receive AFT without the device. Reconstruction will only involve autologous fat grafting. The EVEBRA device is designed to support the fat transfer process. During the study, participants will be monitored for breast volume changes using MRI over one year. Researchers will also evaluate aesthetic outcomes, quality of life, and any complications. The study includes assessments of safety and effectiveness, with follow-up visits to track progress and device tolerance. Participation includes regular evaluations and adherence to device use as instructed.

Researchers are evaluating the long-term safety, performance, and clinical benefits of the G7 Acetabular Shells used with Vivacit-E and Longevity highly crosslinked polyethylene (HXLPE) liners in patients undergoing primary or revision total hip arthroplasty. The study focuses on patients treated for various hip conditions such as degenerative joint disease, osteoarthritis, avascular necrosis, rheumatoid arthritis, fractures, and related disorders. The main goal is to confirm how well the implant system lasts and functions over a 10-year period. Participants will receive either the Vivacit-E or Longevity HXLPE liner, with 150 subjects assigned to each group. This dual cohort study involves implanting the G7 Acetabular System along with the assigned liner and instrumentation during hip replacement surgery. The study will monitor the implants and patients over time to assess device survival and clinical outcomes. During the study, participants will have follow-up visits where researchers will assess the survival of the implant using statistical methods and monitor any adverse events related to the implant or instrumentation. Patient-reported clinical outcome measures (PROMs) and radiographic results, if available, will be recorded to evaluate performance and benefits. Safety and effectiveness will be followed for up to 10 years after implantation.

Researchers are evaluating how to introduce a new method using indocyanine green (ICG) dye and a special camera to locate the sentinel lymph node during breast cancer surgery. The sentinel lymph node is the first node where cancer may spread. The current standard uses a radioactive tracer called technetium-99m (99mTc), which requires extra hospital visits and exposes patients to radiation. ICG offers advantages like no radiation, no extra visits, and lower costs but is not yet widely used in the Netherlands due to unfamiliarity and uncertainty about switching methods. The study involves three phases across several Dutch hospitals: Phase I uses the current 99mTc method only; Phase II uses both 99mTc and ICG together; and Phase III uses ICG only. During surgery, ICG is injected after anesthesia and before the lymph node is removed, with imaging to guide the procedure. In Phase II, the surgeon confirms findings with the radioactive tracer, while Phase III fully relies on ICG. The hospitals will implement these phases step-by-step following a planned schedule. Participants undergo the sentinel lymph node biopsy as part of their planned breast cancer surgery, with no extra hospital visits. After surgery, they complete a short 10-15 minute questionnaire about their experience. Researchers will collect data from hospital records and surveys to measure how well ICG is adopted, patient satisfaction, safety, and effectiveness. The study aims to create a standardized protocol and educational materials to support nationwide adoption of ICG for sentinel lymph node biopsy.

Researchers are studying breast cancer patients who have cancer that has spread to lymph nodes and are treated with neoadjuvant systemic therapy (NST), which includes chemotherapy and sometimes immunotherapy. The study focuses on how to best check and treat the lymph nodes after NST, comparing less invasive methods to the traditional axillary lymph node dissection (ALND). The goal is to see if less invasive techniques can offer similar cancer control and quality of life benefits. This multicenter observational study includes patients with positive lymph nodes who receive NST followed by breast and axillary treatment. Data on patient characteristics, tumor details, staging before and after NST, and treatments will be collected into a national database. Patients will complete quality of life questionnaires at diagnosis, and then 1 and 5 years later to understand the impact of different axillary treatment strategies. Participants will be followed for 5 years to evaluate disease-free survival, breast cancer-specific survival, overall survival, and rates of cancer returning in the lymph nodes. Quality of life will be measured using multiple questionnaires over time. The study aims to provide evidence to improve national guidelines and support shared decision-making about axillary treatment options for node positive breast cancer patients.