Assen

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 chemotherapy dosing strategies in older patients aged 70 years and above who have metastatic colorectal cancer and are eligible for first-line palliative chemotherapy. This phase III randomized controlled trial aims to compare upfront dose-reduced chemotherapy with standard full-dose chemotherapy, focusing on progression-free survival PFS. Patients are assessed using the Geriatric 8 G8 questionnaire to determine their risk of chemotherapy toxicity, which guides treatment assignment. The study seeks to balance treatment effectiveness with minimizing toxicity, hospital admissions, and maintaining quality of life QoL and physical functioning. Participants classified as low risk for toxicity G8 score 15 or higher are randomized to receive either doublet chemotherapy a fluoropyrimidine combined with oxaliplatin at full dose or with a 25% dose reduction upfront. Those at high risk G8 score 14 or lower or judged high risk by their oncologist receive fluoropyrimidine monotherapy either at full dose or with a 25% dose reduction. The study also allows the addition of targeted treatments like bevacizumab or EGFR inhibitors. Dose adjustments are made for patients with moderate kidney impairment. Chemotherapy is given orally or intravenously on schedules varying between every two and three weeks, depending on the regimen. Participants will be closely monitored throughout treatment, with assessments including radiological or clinical evaluations for disease progression, quality of life and physical functioning questionnaires at 1, 3, 6, and 12 months, and tracking of chemotherapy toxicity, overall survival, treatment cycles, dose changes, hospital admissions, and cumulative drug dosage. Safety and cost-effectiveness will also be evaluated over an average study duration of eight months and up to one year for some outcomes. The study plans to include 587 patients and will continue until December 2028.

Researchers are investigating whether taking breaks from the standard combination therapy of daratumumab, lenalidomide, and dexamethasone Dara-Rd for newly diagnosed multiple myeloma patients affects survival and quality of life. This study aims to compare continuous treatment versus planned treatment-free intervals to see if stopping therapy temporarily may reduce side effects, allow recovery from toxicity, and improve overall well-being while controlling the disease. Participants who have completed 12 cycles of Dara-Rd with at least a partial response and no signs of disease progression will be randomly assigned to one of two groups. One group will continue Dara-Rd therapy without interruption until disease progression, while the other group will stop treatment temporarily and restart it at biochemical progression, continuing until disease progression. The trial is open-label and will follow patients for several years to assess outcomes. Throughout the study, researchers will monitor participants event-free survival and progression-free survival for up to about 57 and 69 months, respectively. Additional assessments include side effect burden, patient-reported quality of life, treatment costs, treatment-free interval length, response times, and survival after second-line therapy. Regular evaluations will help determine how treatment interruption affects toxicity, dose intensity, and overall treatment outcomes over the long term.

Researchers are studying the gut microbiome in adults with metastasized or irresectable colorectal cancer CRC who are receiving chemotherapy. The study aims to understand how the gut microbiome changes during treatment and how these changes relate to the effects of chemotherapy. This research is important because even though treatments are improving, survival rates remain low and side effects are common, so better tools to predict treatment response are needed. Participants in this observational study will provide fecal samples at home before starting treatment and again three months after treatment begins, coinciding with their response evaluation. They will also fill out questionnaires about factors that may affect the microbiome, such as the use of antibiotics or proton pump inhibitors. Additionally, blood samples will be collected before treatment and three months later for storage and analysis. During the study, researchers will track participants response to chemotherapy and any serious side effects over two years. They will use various tests, including stool sample analysis, questionnaires, and blood tests, to gather data. The total duration of participation and follow-up extends for at least two years to help predict treatment outcomes and side effects based on microbiome changes.

Researchers are comparing robot-assisted radical prostatectomy RARP and external beam radiotherapy EBRT, sometimes combined with androgen deprivation therapy ADT, for men with high-risk non-metastatic prostate cancer. The study aims to understand differences in quality of life, functional outcomes, cost-effectiveness, progression-free survival, and distant metastasis-free survival. There is currently no clear consensus on which treatment is better, leading to variation in hospital practices. Participants will receive either RARP, which may include pelvic lymph node dissection and possibly adjuvant radiotherapy or androgen deprivation therapy, or EBRT delivered at an effective radiation dose, possibly combined with a brachytherapy boost and pelvic lymph node dissection. Positive lymph node findings will not exclude participants and may be treated with lymph node irradiation. Treatment details vary based on clinical decisions. During the study, participants will be followed for up to five years, with key assessments at three years including health-related quality of life and functional outcomes. Cost-effectiveness will also be evaluated at three years, while progression-free and distant metastasis-free survival will be tracked up to five years. The study involves regular monitoring to gather these outcomes and support shared decision-making for future patients.

Researchers are investigating how various factors beyond tumor stage, such as biochemical, histopathological, genomic, environmental, and clinical characteristics, affect the outcomes of patients diagnosed with colorectal cancer CRC, small bowel cancer, and anal cancer. This observational study aims to collect detailed information from diagnosis through long-term follow-up to better understand prognosis and treatment effects in both early and late-stage cancers. The study addresses the gap between clinical trial populations and real-world patients by including a broader patient group treated in general practice. Participants will be followed prospectively from their initial diagnosis until death. Data collection includes medical history, clinical parameters, imaging, pathology, tumor details, treatments, hospital stays, interventions, and adverse events. With separate consent, patient-reported quality of life and work ability information will also be gathered. Additionally, biological samples obtained during routine care may be collected for further observational and molecular research. This cohort serves as a platform for evaluating new interventions through a Trials within Cohorts TwiCs design. Throughout up to ten years of follow-up, participants will undergo assessments of progression-free survival, disease-free survival, overall survival, and serious adverse events. Quality of life and work ability are assessed at intervals of 3, 6, 12, 24, 36, and 48 months. This extensive data collection supports a wide range of research aims including prognostic studies, molecular analyses, comparisons of new treatments, and health policy evaluations. The study provides a comprehensive view of treatment outcomes and patient experiences in everyday clinical settings.

Researchers are investigating a new virtual reality treatment called VR-VOICES for people who hear distressing voices auditory verbal hallucinations related to psychiatric disorders. These hallucinations often cause significant distress and disability, and current psychological treatments have limited effectiveness. This trial aims to evaluate how VR-VOICES affects the severity and frequency of these voices, clinical symptoms, quality of life, and healthcare costs. The study is a single-blind randomized controlled trial comparing VR-VOICES plus treatment as usual TAU against TAU alone. VR-VOICES includes 7 to 10 individual therapy sessions lasting 45 to 60 minutes, plus two booster sessions, where patients and therapists create a virtual avatar representing the voice that bothers them most. Patients engage in dialogues with this avatar, which becomes less hostile over time as they build resilience. TAU involves usual care such as medication, counseling, and psychological therapies like CBT. Participants will be assessed at the start, during some VR sessions, after 12 weeks, and at 6 months follow-up. Researchers will collect data on voice severity, beliefs about voices, anxiety, distress, impact on daily life, clinical symptoms, costs, and quality of life through questionnaires, diaries, and interviews. The main measure is the severity of hallucinations at 3 months. The study will involve 112 patients aged 16 or older with persistent distressing voices and psychiatric diagnoses.