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Safety and Efficacy Study of Hypofractionated Radiotherapy for Localized Prostate Cancer: a Single-arm Clinical Trial
The aim of this trial is to study the safety outcomes of hypofractionated radiotherapy in treating patients with localized prostate cancer. Hypofractionated radiotherapy delivers higher doses of radiotherapy in a shorter time period, may enabling the killing of more tumor cells with fewer side effects. Accumulating evidence has proven the safety and feasibility of hypofractionated radiotherapy for localized prostate cancer.But for localized prostate cancer,the optimal dose per fraction of hypofractionated radiotherapy is still on its way.
The present study will be conducted as a prospective, open-label, single-arm clinical trial. The patients will receive hypofractionated radiation(54 Gy in 15 daily fractions of 3.6 Gy ). After completion of study treatment, patients were followed up once a month for the first 3 months and once every 3 months after 3 months for a total of 5 years. The primary endpoints of the study are the toxicities about gastrointestinal (GI),genitourinary (GU) symptoms and erectile dysfunction.The secondary endpoints include progression-free survival (bPFS), local progression-free-survival(LPFS) ,distant metastasis free survival(DMFS) ,overall survival (OS)and quality of life (QoL).
Age
18 - No limit years
Sex
MALE
Healthy Volunteers
No
Changhai hospital
Shanghai, Shanghai Municipality, China
Start Date
September 1, 2024
Primary Completion Date
September 1, 2026
Completion Date
September 1, 2031
Last Updated
August 26, 2024
20
ESTIMATED participants
Hypofractionated radiation therapy
RADIATION
Lead Sponsor
Changhai Hospital
NCT07450599
NCT02662673
Data Source & Attribution
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View ClinicalTrials.gov Terms and ConditionsNCT00196781