Hengelo

Researchers are studying metastatic castration-resistant prostate cancer mCRPC to find new treatment options. This trial evaluates if the study medicine ifinatamab deruxtecan I-DXd or MK-2400 helps people live longer overall and experience slower cancer growth or spread compared to chemotherapy. The study is a Phase 3 trial comparing I-DXd with standard chemotherapy for mCRPC patients. Participants are randomly assigned to receive either I-DXd at 12 mgkg every 3 weeks through intravenous infusion or docetaxel chemotherapy at 75 mgm2 every 3 weeks combined with daily prednisone pills. Treatment continues until the disease progresses, unacceptable side effects occur, or treatment is stopped for other reasons. Premedication is given before each dose of I-DXd to help prevent nausea and vomiting. During the study, participants will have regular visits for treatment and monitoring. Researchers will assess overall survival and radiographic progression-free survival for up to about 36 months. Additional measures include response rates, time to pain progression, PSA progression, and adverse events. The study tracks safety, treatment effects, and quality of life over a long follow-up period to better understand the potential benefits and risks of I-DXd compared to chemotherapy.

Researchers are monitoring the effectiveness and safety of Autologous Fat Transfer AFT with pre-expansion as a method for full breast reconstruction in female breast cancer patients. This multicenter, prospective cohort study follows the BREAST trial and aims to evaluate quality of life, aesthetic outcomes, complications, oncological safety, and cost-effectiveness of AFT. All participants will receive AFT in this observational study. Participants will undergo breast reconstruction using Autologous Fat Transfer combined with an external expansion device. This procedure is offered to women who have had or will have a mastectomy, including preventive mastectomy. The study focuses on assessing various outcomes over several years, with particular attention to quality of life and aesthetic results at two years, and oncological safety up to five years after treatment. During the study, participants will be monitored for breast-related quality of life, aesthetic results, any complications, oncological safety, and the cost-effectiveness of the procedure. These outcomes will be assessed through regular follow-ups and evaluations over a period of two to five years. The study is led by Maastricht University Medical Center and aims to provide comprehensive information on this breast reconstruction method.

Researchers are evaluating a shorter treatment duration with androgen receptor pathway inhibitors ARPIs, specifically Apalutamide or Enzalutamide, in patients with low-volume hormone-sensitive metastatic prostate cancer. This phase 3 clinical trial aims to determine if stopping ARPI therapy after 12 months, with the option to restart if the cancer progresses, is not worse than continuing ARPI treatment. The goal is to reduce side effects and costs while maintaining effective disease control. Participants will be randomly assigned after completing 12 months of ARPI treatment to one of two groups one group will continue androgen deprivation therapy ADT combined with ARPI, while the other will stop ARPI after 12 months but may restart it if a confirmed rise in prostate-specific antigen PSA occurs. The PSA confirmation sample must be taken at least four weeks after the initial rise. Treatment will be monitored closely according to these protocols. During the study, participants will be followed for up to 6 years, including 5 years after randomization to track clinical progression-free survival. Researchers will regularly assess disease status, treatment effects, and possible side effects. The study includes regular visits and monitoring to evaluate how long patients remain free from disease progression while comparing the two treatment approaches.

Researchers are evaluating the AtMoves Knee System to improve the diagnosis of aseptic loosening in patients who have received a total knee replacement. The main goal is to find out if using this specialized device during a CT scan can reduce the number of failed outcomes, defined by patient-reported knee function scores not showing meaningful improvement at 12 months. The study compares two groups to see if the AtMoves Knee System helps in clinical diagnosis and treatment decisions. Participants are randomly assigned to one of two groups. The intervention group undergoes a CT scan using the AtMoves Knee System, which applies specific forces to detect movement of the knee prosthesis component. Both groups continue with diagnostic and treatment plans determined by their orthopedic surgeons, with the control group not receiving the specialized CT scan. This allows researchers to assess the added value of the AtMoves system in routine clinical care. During the one-year follow-up period, participants complete questionnaires about their knee function. Researchers will track the percentage of failed outcomes, revision surgeries, diagnostic activities, related costs, medical use after diagnosis, societal productivity loss, and participant satisfaction with the AtMoves procedure. The study aims to provide a comprehensive evaluation of this diagnostic tools impact on patient outcomes and healthcare use.

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. Treatment usually starts with inserting a catheter to empty the bladder and taking medication called alpha-blockers. This study compares two different lengths of catheter use before trying to urinate again, known as the Trial Without Catheter TWOC, to find out if a shorter catheter period is as effective and safe as a longer one. The trial includes 478 men with AUR who all receive a catheter and start or continue alpha-blocker treatment. Participants are randomly assigned to have the catheter removed either after three days or after fourteen days. The study examines if the shorter catheter duration works as well as the longer one in allowing normal urination without needing catheter replacement. It also looks at complications, patient comfort, quality of life, and healthcare costs. During the study, researchers will monitor how many men need re-catheterization after their TWOC, assess patient-reported symptoms and quality of life at multiple time points up to six months, and track complications and healthcare expenses up to 18 months after catheter insertion. The goal is to identify the best timing for catheter removal to reduce discomfort and complications and improve care. Participation lasts through these assessments and follow-ups as scheduled by the research team.

Researchers are studying the MiLES intervention aimed at employers to help employees with cancer successfully return to work. This randomized controlled trial will compare the MiLES intervention to usual care, assessing its effectiveness, cost-effectiveness, and impact on quality of life for employees with cancer and their employers. The study includes 140 pairs of employees with cancer and their employers, focusing on improving return-to-work outcomes within a year. The study involves two groups one where employers access the web-based MiLES intervention featuring interactive videos, conversation checklists, tips, and information to better support employees with cancer during sick leave and return to work and a control group receiving usual care without access to MiLES during the study. Employers in the control group will receive access to MiLES after a 12-month waiting period. The MiLES intervention encourages effective communication and support between employers and employees. Participants will complete questionnaires at the start and at 3, 6, and 12 months to assess return to work, quality of life, work-related support, and satisfaction for both employees and employers. The study also evaluates employers confidence in providing support and satisfaction with the return-to-work process. Researchers will monitor outcomes and perform cost-effectiveness analyses from the employers perspective. The total follow-up period for each participant is 12 months.

This trial focuses on female breast cancer patients who are scheduled for or have already undergone mastectomy. The study evaluates a new breast reconstruction method called autologous fat transfer AFT using the EVEBRA external vacuum expansion device compared to the standard AFT approach without the device. The goal is to assess differences in breast volume, quality of life, aesthetic outcomes, complications, and oncological safety. Participants are randomized into two groups one group receives AFT combined with the EVEBRA device, which requires wearing the device for 200 hours before surgery over two weeks and then 10 hours daily for two weeks after surgery. After this, they wear a PexyBra over the reconstructed breast. The other group receives AFT without using the EVEBRA device. Reconstruction is performed with three fat grafting sessions. During the study, participants undergo MRI to measure breast volume and tissue quality, complete the Breast-Q questionnaire to assess satisfaction, have breast sensation tested with monofilaments, and have photographic evaluations at 12 months. Researchers will also measure chest circumference and bra cup size changes. The total study period includes follow-up at one year to monitor outcomes, safety, and patient experiences with the reconstruction methods.

Breast cancer affects about one in seven women, and determining if cancer has spread to the lymph nodes is vital for treatment planning and predicting outcomes. This trial evaluates a new method using indocyanine green ICG fluorescence imaging to identify the sentinel lymph node during breast cancer surgery. The study aims to introduce ICG into regular hospital care in the Netherlands, comparing it to the current standard method using a radioactive tracer, technetium-labeled 99mTc-nanocolloid, which has logistical challenges and exposes patients to radiation. The trial is conducted in three phases first, using the standard 99mTc method second, a transition phase combining both 99mTc and ICG and third, fully implementing ICG alone. During surgery, ICG is injected after anesthesia and visualized with a special camera to locate lymph nodes, while 99mTc requires preoperative injection and imaging. The study takes place in several hospitals and involves gradually introducing ICG while monitoring and adjusting the process. Participants undergo sentinel lymph node biopsy during planned surgery with no extra hospital visits. After surgery, they complete a short questionnaire about their experience. Researchers collect data on how well ICG is adopted, patient satisfaction, procedure safety, costs, and surgical outcomes. The trial aims to create medical protocols and educational materials to support widespread, sustainable use of ICG in breast cancer care.

Researchers are studying women with node-positive breast cancer who receive neoadjuvant systemic therapy NST, which includes chemotherapy with or without immunotherapy. The study aims to understand the safety and quality of life effects of using less invasive methods compared to more invasive axillary staging and treatment after NST. This is important because patients whose lymph nodes show no remaining cancer after NST may not benefit from extensive lymph node removal, but more evidence is needed about the safety and impact of less invasive approaches. This multicenter observational study collects detailed information on patients treated with NST for node-positive breast cancer. It gathers data about the cancer, staging methods before and after NST, and treatment details from medical records. Patients complete questionnaires about their quality of life at diagnosis, and then 1 and 5 years later. The study database is maintained by the Netherlands Cancer Registry and aims to inform future treatment guidelines. Participants provide information through patient-reported outcome measures and undergo regular clinical follow-up to monitor disease-free survival, breast cancer-specific survival, overall survival, and rates of cancer recurrence in the lymph nodes over five years. Quality of life is assessed using several validated tools at baseline and during follow-up. The study results will help balance treatment decisions between less and more invasive options and support shared decision making for women with this breast cancer type.

Researchers are investigating whether chemotherapy can be safely skipped for patients with certain favorable features of low stage triple-negative breast cancer after surgery and radiation. The study aims to see if avoiding chemotherapy improves patients quality of life. Participants decide with their doctors whether to have chemotherapy or not as part of their treatment. Participants receive surgery and radiotherapy based on local or national guidelines. One group will have chemotherapy omitted, while another group will receive chemotherapy in addition to surgery and radiotherapy. The study compares these two approaches to understand treatment outcomes. Participants will be monitored for up to 96 months to track disease recurrence and survival. Quality of life, fear of recurrence, health worries, and cost effectiveness will be assessed up to 2 years after inclusion. Various questionnaires and clinical evaluations will be used to measure these outcomes and ensure participant safety throughout the study.