Clinical trials

The goal of this study is to assess the feasibility of high-dose radiotherapy (Single-Dose Radiotherapy, SDRT) of 24 Gy in patients with localized low and intermediate risk prostate cancer using a special system of internal and external immobilization of the prostate gland. Patients eligible for this study are classified according to the National Comprehensive Cancer Network (NCCN) guidelines as low or intermediate risk prostate cancer (Stage T1-T2c and/or Prostate Specific Antigen (PSA) level ≤20 ng/mL and/or Gleason score of ≤7). The study will examine the technical feasibility of image-guided volumetrically-modulated arc therapy (VMAT-IGRT) with an emphasis on normal tissue sparing and precision of radiation delivery using dedicated devices (an air-filled endorectal balloon and a Foley catheter) that ensure target immobilization and reproducibility of prostate anatomical localization using a special external patient immobilization system, including patient placement on the patient transfer trolley, which allows patient transfer without removing the endorectal balloon and urinary catheter during all stages of simulation and treatment planning (MR, CT, Positron emission tomography (PET) / CT-simulation) and during the treatment session on the linear accelerator. Previously untreated patients with localized prostate cancer of the low risk and favorable intermediate risk (NCCN) groups will receive SDRT at a dose of 24 Gy. In patients from the unfavourable intermediate risk (NCCN) group with a visible dominant intraprostatic lesion (DIL), local escalation of the DIL dose to 30 Gy will be performed. Patients will be followed up at one week and one month after completion of treatment, then every 3 months for 24 months (+/- 4 weeks), and every 6 months thereafter. Evaluation of early and late adverse events will focus, although not exclusively, on the genitourinary and gastrointestinal toxicity, primarily the rectal toxicity. Serum prostate-specific antigen (PSA) levels will be determined according to the clinical follow-up schedule. Multiparametric magnetic resonance imaging (mpMRI) with intravenous contrast will be performed at baseline and at 6-, 12-, and 24-months post-intervention. Participants of the study will be followed up for at least 2 years after treatment.

There is currently no consensus on the "gold standard" for Implant-based Breast reconstruction. In the United States, more than half of all breast reconstructions are performed using acellular dermal matrix (ADM). However, based on the findings of literature and systematic reviews, it can be cautiously said that synthetic meshes cause fewer complications with comparable aesthetic results and low cost. In our study, we propose using polytetrafluoroethylene (PTFE) mesh in implant-based breast reconstruction. This material has previously proven itself in cardiovascular, maxillofacial and neurosurgery, hernioplasty and as a suture material. Allogeneic dura mater, which has demonstrated comparable results in breast reconstruction with the literature, will be used as a comparison. The purpose of this study is to evaluate the efficacy and safety of a porous, non-biodegradable, synthetic polytetrafluoroethylene mesh for implant-based breast reconstruction in patients diagnosed with breast cancer. An allogeneic dura mater technique will be used as a control. Patients eligible for this study are classified according to the National Comprehensive Cancer Network (NCCN) guidelines as having stage 0-2 breast cancer. The primary questions this study aims to answer are: * What are the rates of major and minor complications associated with these techniques. Major complications will be defined as complications leading to reoperation. * How effective are PTFE mesh and dura in maintaining the inframammary fold and implant projection after breast reconstruction? * What is the patient satisfaction rate with the surgical results? Patients will be randomly assigned to the study but will know which technique will be used in their particular case. Patients included in this study will undergo subcutaneous mastectomy or skin-sparing mastectomy using standard techniques with simultaneous implantation using PTFE mesh or allogeneic dura mater graft. In our opinion, the mesh and graft will stabilize the projections of the inframammary fold and breast implant. After the surgery, all minor and major complications will be recorded for 6 months. For this, both physical examination and radiological diagnostic methods will be used, including breast ultrasound and MRI with contrast. Revision surgeries will be performed if necessary. Projections of the inframammary fold and breast implant will also be measured in order to determine the effectiveness of the compared techniques. Patients will be asked to complete the BREAST-Q Version 2.0© Reconstruction Module questionnaire to determine satisfaction with the surgical outcome. The results of the study will help the professional community to determine the most effective method of Implant-based Breast reconstruction and will be published in peer-reviewed scientific journals.