Pori

Researchers are investigating better ways to detect significant prostate cancer in men who are suspected of having the disease. The study compares two approaches: one where all men receive prostate biopsies after a pre-biopsy MRI scan, and another where biopsies are done only after a shared decision between the patient and urologist based on a risk estimate for prostate cancer. The trial involves 600 men and focuses on detecting clinically significant prostate cancer, defined as Gleason 4+3 or higher, at baseline. Participants are randomly assigned to one of two groups. In the control group, all men undergo prostate biopsies after an MRI scan. In the intervention group, biopsies are performed only after shared decision-making that considers prostate cancer risk factors such as age, medication use, PSA levels, MRI findings, and prostate volume. The MRI scans are evaluated by experienced radiologists using specific classification systems. Men with negative or no biopsies enter a five-year follow-up with PSA testing every six months. During the study, participants undergo MRI scans and discussions with their urologist about biopsy decisions. Those without significant findings are monitored with regular PSA tests for five years, followed by long-term health record tracking for 15 more years. The main outcome measured is the proportion of men diagnosed with clinically significant prostate cancer at the study's start. Safety and patient status are closely monitored throughout the trial.

Implantation of a drug-eluting stent (DES) has become a standard of percutaneous coronary intervention (PCI) during the last two decades. However there are still significant drawbacks in using DES as a permanent coronary implant. Most importantly, bleeding remains a significant complication of PCI, especially in elderly patients. The number of PCI patients having OAC:s is already significant, and will grow in the future, as the volume of PCIs in octogenarians increases, and so does the incidence of atrial fibrillation by age. After stenting at least one month lasting dual antiplatlet treatment (DAPT) is mandatory, and it cannot be safely terminated in case of a bleed. The optimal duration of DAPT on patients at bleeding risk is not known. Balloon coated with paclitaxel and iopromide (drug-coated balloon, DCB) was originally developed for the treatment of in-stent restenosis, but later its potential for the treatment of de-novo coronary artery leasons has become clear in large registry trials. So far, the randomized controlled studies have shown the non-inferiority of PCI using DCB in comparison to DES in de novo leasons in small vessels. Also the non-inferiority of PCI using DCB in comparison to BMS was shown in the DEBUT trial in large vessels on patients at high bleeding risk. These results need to be confirmed in comparison of DCB to DES as the use of BMS is diminishing. The hypothesis of the DEBATE trial is that the strategy using DCB and a shorter DAPT regimen is non-inferior to the treatment using DES and longer DAPT duration in the treatment of stable CAD or in ACS (UAP or NSTEMI) in patients on anticoagulation medication or otherwise on high bleeding risk. If non-inferiority is shown, the superiority of the DCB strategy over DES strategy will be tested.

Researchers are evaluating treatments for older adults with displaced distal radius fractures caused by low-energy injuries, such as falls from less than 1 meter. This randomized controlled trial, called the DISCLOSE trial, involves 532 participants aged 65 years or older living independently. The study aims to determine if casting without prior closed reduction is as effective as casting after closed reduction in reducing wrist pain and disability, measured by the Patient-Rated Wrist Evaluation (PRWE) score at 12 months. Participants are randomly assigned to one of two groups. In the "no reduction" group, a dorsal cast is applied immediately after the initial X-ray without attempting to realign the fracture first. In the "closed reduction" group, the fracture is realigned under local anesthesia before casting. Both groups have their cast removed after 5 weeks and are encouraged to resume normal wrist use without restrictions. Patients who decline randomization may join an observational group receiving standard care with closed reduction and casting. Participants attend follow-up visits at 3 and 12 months, with wrist X-rays at 3 months. Follow-up can be in person or remotely via phone or email, with wrist activity monitored by accelerometer wristbands sent by mail. Questionnaires assessing wrist function and pain are completed before follow-up appointments. A 5-year phone follow-up is planned. Participants with ongoing symptoms may receive physiotherapy for up to one year and, if needed, further evaluation including CT scans or surgery. The primary outcome is the PRWE score at 12 months post-injury.

Background: Non-operative management (NOM) for rectal cancer is an accepted treatment option that has not been commonly utilized in Finland but has been widely adopted in major cancer centers worldwide. NOM can be considered if the rectal tumor disappears with neoadjuvant treatment, resulting in a complete clinical response. Objective: The aim of the study is to establish a unified NOM protocol for national use and determine whether the outcomes of Finnish and Estonian treatment practices align with international experiences. Design: The study is a prospective, non-randomized, single-arm, international multicenter trial examining the oncological and quality-of-life consequences of NOM. Primary Endpoint: The primary endpoint is disease-free survival 2 years after the initiation of NOM. Secondary Endpoints: These include overall survival, disease-specific survival, survival free from total mesorectal excision (TME) surgery, survival free from circulating tumor DNA (ctDNA) detection after complete clinical response, recurrence-free survival, incidence of local recurrence and metastases, salvage TME success rate, quality of life at 1 year post-NOM, and treatment-related morbidity up to 5 years. Inclusion Criteria: Patients must have histopathologically confirmed primary rectal adenocarcinoma before neoadjuvant treatment, achieve clinical complete response (cCR) after neoadjuvant therapy, and express willingness to undergo rectum-preserving treatment after considering the risk of recurrence. Exclusion Criteria: Patients with evidence of metastasis at diagnosis, aged under 18, those not receiving neoadjuvant treatment, or those unable to provide informed consent are excluded. Diagnosis and Treatment: Pretreatment of patients follows standard practice. Upon meeting inclusion criteria with confirmed cCR, patients undergo protocolized monitoring with clinical examination, laboratory tests, and imaging. Randomization: No randomization is performed. Follow-up: Patients are monitored every 3 months for the first 2 years, then every 6 months for 3 years. Monitoring replaces surgical intervention unless cancer recurs. Follow-up is part of standard care, with costs covered by the healthcare system. Safety: Incidence of local recurrence and success of resection post-recurrence are monitored closely. If over 30% local recurrence occurs post-cCR, it may necessitate study termination at the center. Data Collection: Clinical data are entered into electronic case report forms (eCRFs) based on primary healthcare documentation and stored pseudonymized on the primary research center's server. Molecular and pseudonymized clinical data are collected securely for analysis. Sample Size Calculation and Statistical Analysis: A sample of 200 patients is estimated to provide sufficient data for the primary and key secondary endpoints and to meet other study objectives accurately. Data Handling: Data handling adheres to privacy legislation, with information stored pseudonymously.

Urothelial cancers of the bladder and upper urinary tract cause significant illness and death worldwide, with over 600,000 new cases and 200,000 deaths each year. Many patients present with blood in the urine, which often leads to invasive bladder examinations called cystoscopies. However, only about 10% of these cystoscopies detect cancer, creating a need for better diagnostic methods. The UROSCOUT-1 trial is a prospective multicenter observational study aimed at evaluating whether urine tumor DNA (utDNA) testing can reduce the number of cystoscopies needed for patients suspected of having urothelial cancer. This study collects urine samples by mail from patients scheduled for cystoscopy to rule out urothelial cancer. The samples are then analyzed without knowing the patients' cancer status. To balance the study groups, random subsampling is used to create a roughly equal number of cancer-positive and cancer-negative patients. The goal is to see if utDNA testing can potentially replace many cystoscopies, improving patient quality of life and reducing healthcare costs and workloads. Participants will provide urine samples and undergo their scheduled cystoscopy. Researchers will measure the sensitivity and specificity of the utDNA test for detecting urothelial cancer one year after diagnosis. The study will monitor and compare test results with clinical outcomes to assess if utDNA testing can serve as a reliable alternative to cystoscopy. The participation includes sample mailing and follow-up over a year.

Researchers are investigating whether a simple home exercise program can help patients with advanced chronic kidney disease (CKD). The study also includes an observational group without the exercise program to examine the link between cardiovascular and kidney health, exercise capacity, and adverse outcomes. The research focuses on risks such as premature death, cardiovascular events, hospital visits, and kidney function decline, particularly in patients who are frail and elderly. Participants receive a single session with a registered physiotherapist who teaches them how to perform physical training exercises independently at home at least three times a week throughout the study. The study includes a controlled trial of this physical education program along with an observational follow-up to assess its effects. Researchers will track outcomes such as mortality, major cardiovascular or cerebrovascular events, emergency department visits, hospitalizations, need for dialysis, and walking capacity over multiple years. Throughout the study, patients will undergo evaluations including blood tests, X-rays, quality of life assessments, and exercise capacity measurements. The study will monitor compliance with the home exercise program and measure long-term health outcomes up to December 2031. This comprehensive approach aims to understand how frailty and physical activity affect health in advanced CKD and whether exercise can improve prognosis and quality of life.

Researchers are evaluating the safety and effectiveness of a drug called PF-07220060 combined with letrozole compared to other approved treatments (palbociclib, ribociclib, or abemaciclib with letrozole) in adults with breast cancer that is hormone receptor-positive and HER2-negative. This cancer has spread locally or to other parts of the body and has not been treated with systemic anti-cancer therapy for advanced or metastatic disease. The study is a Phase 3, open-label, randomized trial involving multiple centers. Participants will be randomly assigned to receive either PF-07220060 plus letrozole or the investigator's choice of one of the approved CDK4/6 inhibitors (palbociclib, ribociclib, or abemaciclib) combined with letrozole. The treatments are given as drugs with letrozole serving as endocrine therapy. The study compares these treatments in terms of how well they control the cancer and their safety profiles. Participants will visit the study clinic regularly for monitoring during treatment. Researchers will assess how long participants live without their disease worsening or dying from any cause, which is the main outcome measured up to about four years. The study team will monitor each participant's health and response to treatment through these visits to gather information about treatment effects and safety.