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IRCT20211004052674N1 IRCT 2021-12-11 Ahvaz University of Medical Sciences Comparison of serum profile of inflammatory cytokines in localized prostate cancer patients Comparison of serum profile of inflammatory cytokines in high or unfavorable intermediate-risk localized prostate cancer patients treated with definitive whole pelvis radiation therapy plus external beam boost versus high dose rate brachytherapy boost. 2021-11-11 anticipated 20 Complete https://irct.ir/trial/59798 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple individual randomization with a sealed envelope Twenty letters are used in the form of ten group A numbers and ten group B numbers People in group A will only receive external beam radiotherapy, and people in group B will be treated with brachytherapy. N/A Prostate Cancer. Intervention 1: Control group: This group undergoes external radiotherapy. Before the start of treatment and after one month and three months after the end of external radiotherapy, the level of inflammatory cytokines of interleukin 6, interleukin 8 and TNF alpha are evaluated. Intervention 2: Intervention group: In addition to external radiotherapy, this group undergoes brachytherapy. Before the start of treatment and one month and then three months after the end of treatment, inflammatory levels of interleukin 6, interleukin 8 and TNF alpha are evaluated. Yes - There is a plan to make this available What will be shared: Information about the main outcome or the like can be shared When: Access period starts 6 months after the results are published To whom: Academic and scientific community Conditions: Use in clinical studies Where to obtain: Ahvaz Jundishapur University How to obtain: Send request to Ahvaz Jundishapur University Comments:
public Ali bagheri
Golestan hospital, Farvardin street
Ahvaz Iran (Islamic Republic of) 3311861357 +98 61 3374 3001 alibagheri.md@gmail.com Ahvaz University of Medical Sciences scientific Ali bagheri
Golestan hospital, Farvardin street
Ahvaz Iran (Islamic Republic of) 3311861357 +98 61 3374 3001 alibagheri.md@gmail.com Ahvaz University of Medical Sciences Iran (Islamic Republic of) Age ≥18 year Eastern Cooperative Oncology Group (ECOG) performance zero or one Localized prostate adenocarcinoma confirmed by pathology with moderate (Unfavorable) and high risk according to National Comprehensive Cancer Network criteria(NCCN) (first edition 2021) 18 years no limit Male Severe physical illness or mental disorder that, according to the researcher, prevents treatment according to the protocol Patients who cannot be followed up regularly Contraindications for external radiotherapy or brachytherapy Previous history of external radiotherapy or prostate brachytherapy History of any prostate surgery Any history of malignancy (except for non-melanoma skin cancers) History of Chemotherapy, Targeted Therapy and the use of immunosuppressive drugs History of chronic infectious diseases (HIV, viral hepatitis, etc.) Treatment - Devices Treatment - Devices Control group: This group undergoes external radiotherapy. Before the start of treatment and after one month and three months after the end of external radiotherapy, the level of inflammatory cytokines of interleukin 6, interleukin 8 and TNF alpha are evaluated Intervention group: In addition to external radiotherapy, this group undergoes brachytherapy. Before the start of treatment and one month and then three months after the end of treatment, inflammatory levels of interleukin 6, interleukin 8 and TNF alpha are evaluated Serum profile of inflammatory cytokines. Timepoint: Serum levels of inflammatory cytokines are measured two weeks before the start of radiotherapy, and one and three months after the end of radiotherapy. Method of measurement: Blood test. Ahvaz University of Medical Sciences Approved 2021-11-05 Ethics Committee of Ahvaz Jundishapur University Golestan hospital, Farvardin street ahvaz Khouzestan Iran (Islamic Republic of)