Clinical trial: NCT03827616
Section: Alternatives
Subsections: What Are The Alternative Treatment Options If I Do Not Wish To Participate In The Study?

If you decide not to participate in this study or to withdraw your consent to participate in it early, the study doctor may recommend alternative treatments. An alternative option for radiation therapy is treatment in the traditional radiation regime for 7.5 weeks, for 37 sessions, on linear accelerators SL-75, Synergy.
Clinical trial: NCT03827616
Section: Confidentiality
Subsections: Will The Privacy Of My Personal Data Be Protected?

The physician researcher will process your health information that contains personal data, which includes collecting, recording, organizing, storing, storing, specifying, using, transferring, depersonalizing, deleting personal data for conducting this research, in accordance with the conditions set forth in this patient information leaflet.  
Such personal data may include your name, address, telephone number, information about past diseases, photographs (pictures of your internal organs) and other research data, including those obtained as a result of medical care within the system of state guarantees of free medical care to citizens. Data may be requested from your doctor or other medical personnel if you have no objections. The physician researcher has the right to process your personal data, including information about your health. In accordance with the legislation of the Russian Federation, the doctor is obliged to maintain the confidentiality of these data.  
The protection of your personal data is guaranteed during the entire study and after its completion. After signing an informed consent, participants will be assigned unique identification numbers. The personal data of the participants, as well as the associated identification numbers, will be stored with the medical researcher and will not be accessible to third parties. All research data obtained during participation in the study are part of a scientific study and can be used to present the results in scientific publications and public reports (conferences, symposia, defended candidate and doctoral theses), without violating the confidentiality of your data, that is, that does not allow to identify your identity (without specifying the last name, first name, patronymic and other data that allow you to be associated with the presented results).  
Your permission to use and transfer your health data is indefinite. You can at any time withdraw your consent to the use and transmission of data about your health by sending a written notice to the investigator about this.  
However, after this you will be excluded from the study.  
If you have questions about specific medical information about your health that will be used during this study, you can discuss them with a medical researcher. Who / where can I ask questions? For questions: Concerning the study Medical researcher Full name Tel: +7 (843) ___________
Cell: + ________________
Concerning my rights as a research participant:
Local ethical committee Tatarstan Cancer Center 29, Sibirskiy tract 420029 Kazan, Russian Federation Tel: +7 (843) 202-23-86 This scientific study was approved by the Expert Council and the Local Ethics Committee Tatarstan Cancer Center.
Clinical trial: NCT03827616
Section: Duration of Study Involvement
Subsections: What Will Happen And What Is The Duration Of My Participation In This Study?

You will be assigned to one of two groups of the prostate cancer radiotherapy regimen. Distribution will occur in a random way - as when tossing a coin. You and your health care provider will know which prostate cancer regimen you are receiving.  
You will be asked to undergo radiotherapy for prostate cancer on a TomoHD.  
Before radiation exposure, you will undergo a pre-radiation treatment planning computed tomography.  
The duration of the course of radiation therapy, depending on the mode of fractionation, will be from 4 to 5.5 weeks.  
In the future, you will be monitored by a researcher for 10 years. This observation may also be in the form of a telephone contact with you. A research doctor or an authorized center employee will contact you during the period of the study to obtain information about your health. During the study, you will be asked to complete questionnaires assessing your health.
Clinical trial: NCT03827616
Section: Participant Responsibilities
Subsections: To Participate In The Study Should:|Obligations Of The Research Participant:

- read the Patient Information Leaflet carefully, ask all questions you are interested in about the study to the researcher and voluntarily sign the Informed Consent form;
- meet the criteria for inclusion / exclusion in the study;
- provide the research physician with information about your medical and family history;
- provide the results of previous studies,
- there are reasons why you may not be able to participate in this study (for example, in the presence of severe concomitant pathology and other contraindications). Discuss these questions with a medical researcher.

- provide the medical researcher with information about your medical and family history;
- provide the results of previous studies;
- agree that a researcher can contact you while you are participating in a study and may have access to your medical documentation for analysis only for the purpose of this study described in this fact sheet;
- fill out questionnaires assessing your health.  
How can research procedures affect my well-being, the risks associated with the procedures?  
You may experience discomfort while performing certain procedures.  
In addition, some of them are associated with certain risks:
Radiation therapy:
- slight weakness, dizziness, nausea, lowering blood pressure.  
- a slight decrease in the level of leukocytes and platelets in the blood.  
- increased urination, a burning sensation, pains during urination, the appearance of blood in the urine.  
- Increased defecation, change in stool consistency, discomfort in the perianal area, lower abdominal pain.
Clinical trial: NCT03827616
Section: Procedures
Subsections: What Procedures Will Be Performed If I Agree To Take Part In The Study?

During the treatment, in consultation with the attending physician, blood and urine will be collected for analysis.  
Pre-radiation treatment planning computed tomography will be carried out by the staff of the Topometric Training Department Tatarstan Cancer Center.
Clinical trial: NCT03827616
Section: Purpose of Research
Subsections: What Is The Purpose Of The Study?

Purpose of the study Compare the results of the two modes of radiation therapy for prostate cancer, at which the dose of radiation delivered in one session, the number of sessions, the total dose of radiation differ.  
The duration of irradiation in the first mode will be 4 weeks, during which, for 20 irradiation sessions every day, the total radiation dose of 60 Gy will be summed up.  
The duration of irradiation in the second mode will be 5.5 weeks, during which, for 28 irradiation sessions daily, a total irradiation dose of 70 Gy will be summed up.  
Our study aims to study the results of radiotherapy for prostate cancer with two different modes of radiation. Both options suggest proven clinical efficacy and safety.  
The system of state guarantees provides free civil medical care.  
You can take part in this study if you have a histologically verified adenocarcinoma of the prostate; age over 18 years and available results of the following studies: transrectal ultrasound of the prostate , pelvic magnetic resonance imaging, osteoscintigraphy; clinical stage T1-3N0M0. There may be reasons that will not allow you to participate in this study. A medical researcher will discuss them with you.  
It will be included approximately 300 patients in this study.
Clinical trial: NCT03827616
Section: Withdrawal from Study
Subsections: What Happens If I Decide To Stop Participating In The Study?

Your participation in this study is voluntary.  
If you decide to stop participating in the study, this will not entail any sanctions or loss of any rights that you had before participating in the study. In the case of your decision to discontinue participation in the study, inform the researcher about this. In what cases / under what circumstances can participation in the study be terminated? For various reasons, your participation in the study may be terminated.  
These decisions can be made if:
- Continuing to participate in this study does not meet your interests from a medical point of view;
- You do not follow the instructions of your medical researcher;
- The investigation is terminated ahead of time.